project management in clinical research

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Clinical research project management: back to basics.

Clinical trials require care and precision regarding planning, coordination, and collaboration. The stakes are high, with participants’ health and well-being and significant investments of both time and money on the line. That’s why clinical research project managers are necessary – to ensure coordinated and collaborative efforts between numerous departments, teams, and vendors that adhere to the study protocol as well as regulatory and ethical standards. In this article, we will take an in-depth look at the basics of clinical research project management.

What is project management in clinical research?

Clinical trials involve several complex, dynamic parts with different boundaries/areas of responsibility, and personnel with specific skill sets and qualifications. As a consequence, successful clinical trials require organizers who are adept at project management.

Clinical trials can be thought of as large-scale, complex projects with multiple milestones and parallel workstreams, including:

• Study and protocol design
• Study startup
• Site activation
• Recruitment
• Documentation (promotional material, informed consent forms, case report forms, protocol documents, surveys, etc.)
• IRB and IEC approval
• Site management
• Investigational product distribution and management of study materials
• Laboratories (analyses, lab tests, imaging, etc.)
• Reporting and regulatory affairs

Why is project management in clinical research important?

Clinical research involves multiple stakeholders. Project management can essentially be thought of as monitoring progress and keeping everyone involved on the same page. Project management is critical for the success of a clinical trial; it helps the different teams stay on schedule, adhere to protocol, and communicate amongst one another, as well as meet the trial objectives/targets, maintain quality standards, stay within budget, and follow regulatory requirements.

The following are three major reasons why project management in clinical research is important:

Timeline management

Project management ensures the delivery of clinical trial objectives and sub-objectives within the allocated time and budget. This is important because nearly 85% of all clinical trials experience delays. [1] Project management techniques can allow investigators to plan ahead if it looks like a deadline is not going to be met, so they can reallocate resources and priorities to accelerate the process, or otherwise notify teams responsible for tasks that would be affected by the resultant delay and adjust the timelines.

Streamline and facilitate communications

It is important for the various stakeholders involved in a clinical trial to be on the same page. Keeping all of these actors updated and facilitating communication amongst them is another task of the project management team. Lack of communication in clinical trials can have negative consequences on the quality of research. [2] An efficient project manager or management team can streamline communication and collaboration between multiple teams and departments, further increasing the transparency of the individual but interdependent operations.

Quality control (QC)

Quality control is another important aspect of clinical research project management. Quality standards are often stringent, but this is designed to protect the safety of participants and the general population. Clinical trials that fail to adhere to or meet quality standards will not be considered to have provided sufficient evidence on the effectiveness and/or safety of an investigational drug. Researchers and investigators tend to be under a lot of pressure as trials are often on tight budgets and timelines, but it is important that quality not be sacrificed in order to meet other objectives.

Project management helps sponsors/investigators manage all objectives and sub-tasks in a clinical trial while still prioritizing adherence to quality and regulatory standards. Part of the task of the project management team may even be to define internal quality standards for specific tasks, objectives, and/or teams.

What does a clinical research project manager do?

A clinical research project manager coordinates with other departments, teams, and personnel involved in the clinical trial to ensure the organized completion of clearly defined tasks. They also manage external vendors such as central laboratories or technology providers. Project managers will monitor the progress of all tasks and objectives to keep the study on track according to its protocol, including timeline and budget, and also communicate with stakeholders such as the sponsor to keep them up to date.

What is the clinical research project manager responsible for?

The responsibilities of a clinical research project manager depend on the specifics of the trial and its complexity, but they generally include the following:

• Planning : This includes general planning of the trial, including the internal organization between departments/teams, how tasks should be executed in order to comply with regulations, how many and which sites to involve, whether external tools/solutions need to be contracted, etc.
• Budgeting : Making sure that the study’s resources are allocated appropriately to the different teams/tasks, within the overall study budget, also providing room for unexpected costs or delays.
• Vendor identification/selection : Negotiation with vendors, technology providers, and suppliers.
• Scheduling : Scheduling the objectives/sub-tasks of the clinical trial and monitoring activities to make sure they are completed on time.
• Liaising : Acting as a central point of contact for members of the project team and sponsors.
• Task delegation : Assigning tasks to team members and updating them about their responsibilities, as well as deadlines and expectations.

What are the key topics included in a clinical research project plan?

The project manager may organize all of the above-mentioned tasks and responsibilities into a document or repository referred to as a clinical research project plan. This plan would formally outline standard protocols for aspects of the clinical research project management, such as:

• Timeline : The timeline should clearly outline specific tasks for each team/department, including their expected initiation and completion dates, and the project manager will ensure tasks and teams are on track. Clinical trials often get delayed, so it is useful to have protocols in place regarding how to deal with potential delays. [3]
• Budget : Often related to unexpected delays, it is not uncommon for projects to end up over budget. The project plan should clearly define budgets, both for teams and for individual tasks, and should outline how deviations from budgets should be dealt with.
• Stakeholder management : The project management plan should outline the content and dates of formal reports for keeping stakeholders updated about the trial’s progress.
• Documentation : The project plan should outline how documentation should be collected, organized, stored, and verified in order to ensure compliance with laws as well as ethical and clinical standards as established by the WHO and ICH guidelines for Clinical Good Practice.
• Site management : Although site monitoring is usually a separate responsibility in clinical trials, the project plan may include instructions and guidelines for individual study sites regarding adherence to protocol, tasks, and timelines. In addition, sites should have clear guidelines on who to contact in the case of any problems, questions, or adverse events that may arise during the trial.
• Data management : The project plan should specify protocol for the collection, secure storage, management, validation, and cleaning of subject information and trial data, in accordance with quality standards and applicable regulations. Proper data management ties in closely with quality assurance, and sound results require healthy data.

Tips for successful clinical research project planning and management

Here are 4 specific tips and ideas for maximizing the efficacy of project management functions in clinical research.

1. Plan with flexibility

Delays can be hard to avoid, especially in the recruitment stage, and they are costly to sponsors. Nonetheless, proper consideration of these potential delays in the timeline (i.e., allowing for some degree of flexibility) can make the difference between the delays simply setting the trial back a few weeks, or ending in the entire trial being canceled.

While delays aren’t ideal, proper planning can allow the sponsors to absorb these delays without them leading to completely missed deadlines and/or cancellation of the trial; in the end, cancellation likely represents a much more significant waste of resources than delays. The same logic can be applied to flexibility in budgeting, as delays may imply additional costs; if these are less unexpected, they can be better absorbed within the trial budget without setting it entirely off track.

2. Identify possible risks and establish mitigation strategies

Perform a thorough analysis of the protocol and utilize specialist knowledge in the fields of medicine and clinical research management to identify and create a list of risks that could arise throughout the clinical trial. Planning ahead of time will allow sponsors to respond rapidly to these risk factors and mitigate them, without having to perform lengthy analyses and coming up with mitigation strategies when it may be too late.

Some potential risks to consider include recruitment delays or low accrual, adverse events, patient dropouts, protocol breaches, problems with study drug supply or distribution, technical failures (of software systems, medical equipment, etc.), and data integrity issues, to name a few. Start with the risks that pose the greatest threat to the integrity of the study, i.e., those which would result in it being canceled, stopped, or rendering the results unusable.

3. Use project management tools

Constantly reviewing all aspects of the clinical trial is a daunting task, so the use of specialized and customizable software solutions can be helpful. There are many such solutions available, from general project management tools to dedicated clinical trial management systems ( CTMS ). These tools can be of significant help in managing, organizing, and overviewing all of the aspects of project management discussed previously, acting as a sort of central dashboard as well as a “safeguard” for the project management plan and tasks.

4. Leverage data automation tools and functions

Similarly to the previous point, data management is another aspect of clinical trials (and clinical trial project management) that can benefit greatly from the assistance of technological tools. Lots of data management functions, including organization, cleanup, and validation, can be streamlined or even completely automated through data processing tools, which are sometimes integrated directly into CTMS or other clinical trial monitoring solutions. The benefits of healthy data include enhanced regulatory compliance and faster progression to data analysis and results once the study data has been collected. Data can also be improved at the source through the use of electronic reporting/collection/recording methods such as:

• Electronic patient-reported outcomes ( ePRO )
• Electronic trial master files ( eTMF )
• Electronic clinical outcome assessments ( eCOA )
• Electronic case report forms ( eCRF )

Conclusions

Clinical research project management is a vital function for keeping the numerous separate yet highly interconnected parts involved in a clinical trial operating in coordination and on track with protocol, budget, timelines, and regulations. There are numerous strategies and tools that can facilitate clinical trial project management tasks and help improve clinical trial quality and speed while still ensuring patient safety and regulatory compliance.

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What to know about project management for clinical trials.

Completing any multi-part task requires organization, coordination, and discipline — and, of course, clinical trials are no exeption. Planning a research study, launching a trial, and keeping things running smoothly requires knowledge and expertise, which is why clinical trial project managers are so vital to the process.

From creating a plan, communicating updates, calculating risks, and addressing any mistakes that arise , solid project management is a necessity to ensure medical research is allowed to move forward. Here, we’ll discuss the role of the clinical trial project manager, as well as tips for developing project plans, stakeholder involvement, communication, IRB submission, and summarizing lessons learned.

What is project management in clinical trials?

The Project Management Institute (PMI) defines project management as the "application of knowledge, skills, tools, and techniques to project activities to meet the project requirements." Project management combines expertise in scope, time, cost, quality, risk management, communication, and stakeholder management in order to move through the five basic phases of any project :

• Project initiation. This phase involves developing an idea, understanding the necessity of the project, and identifying the key decision-makers
• Project planning. This is the phase for making a plan and outlining the work required, including prioritization, budget, schedule, and resources
• Project execution. This is where tasks are distributed by informing all teams of their responsibilities and deadlines
• Project monitoring. This entails implementing project tracking to compare the current project status and progress with the original plan, adjusting as needed
• Project closure. The final phase, where project managers reflect on project success and key learnings for next time

When concerning clinical trials, project management brings all of these phases together to ensure set up, enrollment, operations, and reporting are all done smoothly and effectively. 

Roles of a clinical trial project manager

A clinical trial project manager may have different responsibilities specific to each trial, but in general, they will be tasked with vendor selection, budget oversight, IRB submissions, report creation, and meeting planning, all of which are detailed below.

Vendor selection: Because conducting a clinical trial requires many different elements, outside vendors will often be brought in to provide expertise in certain aspects of a study. This is most common for specialized elements such as Interactive Web Response Systems (IWRS) , electronic patient-reported outcome (ePRO) technology, and clinical trial patient recruitment . Often, it will be the project manager's job to vet these vendors and assist with comparing options.

Timeline and budget oversight: Though every study begins with a specific timeline and budget, nearly 80% of all clinical trials are delayed due to difficulties in patient recruitment, which causes many to exceed their budget. In these situations, a project manager can leverage their expertise to hold the trial team accountable for the time and money spent on the study, in addition to managing expectations should these elements begin to change. 

IRB submissions: Any patient-facing materials involved in research studies must be reviewed and submitted for Institutional Review Board (IRB) approval, and gathering these materials is often the responsibility of the clinical trial project manager. Because every IRB is different, the project manager will need to look at previous submissions and any templates that are available to ensure the study's particular IRB requirements are met.

Report generation: As part of tracking the progress of a trial, clinical trial project managers should regularly generate and distribute reports on various aspects of a study’s progress. These reports can often be automated so they are not a time-consuming task, but they do play an essential role in keeping key stakeholders looped in on the progress of the research.

Meeting coordination: Occasionally, the trial’s key stakeholders may need to meet to review a trial’s progress and address any roadblocks. The project manager will likely be charged with planning and leading these meetings to ensure that all details are covered and relevant updates are provided.

Tips for effective project management in clinical trials

Create a detailed project plan

One of the best ways to circumvent delays and issues in a clinical trial is to create a detailed project plan before the study launches. This plan should include a timeline of milestones, key dates, a task schedule, and any other relevant pieces that can keep the project on track. Some people may prefer pen and paper for this, but there are also many online resources available to help project managers keep track of details and stay on schedule.

Anticipate risk management demands

Every project will have some level of risk, so it’s wise to acknowledge what points of contention may arise and plan accordingly. A few examples of risks associated with clinical trials include:

• Long wait times for IRB approval
• Delays in patient recruitment
• Turnover among site staff
• Changes to the trial protocol

Before the project starts, it can be helpful to come together as a team to discuss potential risks that may arise, share past experiences, and determine how they can be prevented or handled if they do arise.

Understand IRB requirements

In most studies, the project manager will also be tasked with gathering materials and submitting them for approval from the Institutional Review Board (IRB). Every IRB will vary on its guidelines, but IRB administrators should be able to answer any questions to ensure a smooth and efficient process.

Even if the responsibility of IRB submission is a task for the project manager, it can be helpful to enlist additional team members to provide a second set of eyes before the materials are submitted. It is also wise to create a checklist of elements that should be included in the IRB packet to ensure nothing gets left out.

Foster open communication between sites and sponsors

Another important communication piece for project managers is to share feedback from sites back with the sponsor of the trial. Communication is particularly important in relation to sharing updates with sponsors about recruitment or screening challenges the site may be facing. 

Communication tips for project management

One of the most important jobs of a clinical trial project manager is to ensure clear and effective communication with multiple stakeholders. To manage this communication from the onset, it can be useful to create a list of stakeholders, the updates they'll need, and how often they should be informed.

To manage this communication, the RACI project management method can provide a helpful framework to organize stakeholders into four categories based on their involvement in the project and communication needs.

• Responsible: The responsible party is the main point person for communication – this is the stakeholder who does the actual work of this part of the project. For example, when submitting outreach material to the IRB, the person responsible for creating the material may be the lead on the marketing team or the contact at a clinical trial recruitment company.
• Accountable: The accountable person is generally the manager of the responsible party and may wish to be involved in only some of the updates related to the project. Generally, if the responsible party needs approval from their manager, they should do so before sharing updates more broadly.
• Consulted: The consulted party would be any additional stakeholders who should weigh in on a project. The responsible or accountable party can generally help project managers determine who should be involved in the consultation.
• Informed: These are people who are simply kept up-to-date on the progress of the project at appropriate intervals.

A paper on managing clinical trials published by the National Institutes of Health also mentions the importance of keeping the investigators themselves in the loop about a trial, stating, "Investigators need to feel valued and part of an inclusive team answering an important clinical question, so providing regular feedback that ensures they feel involved must be central to a trial's communication strategy." Because the investigators may also have busy clinical practices in addition to being part of the trial, it’s important to respect their time while making them feel involved and informed.

Project managers’ roles after a clinical trial

Project management is an ever-evolving skill and there are lessons to be learned from even the most successful project execution. It’s important that project managers evaluate each trial after it's complete in order to analyze trends and plan for the next one while key learnings are still top of mind. As Hubspot puts it, "a productive project post-mortem is a chance to fully unpack a project's trajectory and dig deeper into why things unfolded the way they did.”

Hosting a project post-mortem meeting involving key stakeholders is advisable. Sending a pre-meeting questionnaire can streamline the process of gathering thoughts on what went well, what didn't, and what could be done better next time. The agenda should include a recap of the project's goals and a review of the results so that any discrepancies can be addressed and everyone is able to come up with actionable takeaways for the future.

If you're interested in learning more about how Antidote begins the clinical trial recruitment process and manages the project throughout, download our recruitment template below.

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Introduction to Clinical Research Project Management

Clinical research plays a pivotal role in advancing medical knowledge and improving patient care. It involves the systematic investigation of new treatments, interventions, and healthcare practices. However, successfully conducting clinical research requires careful planning, coordination, and management. This is where clinical research project management comes into play.

In this article, we will provide a comprehensive introduction to clinical research project management, exploring why project management is essential for the successful execution of clinical trials.

Defining Clinical Research Project Management

Clinical research project management is a specialized discipline that focuses on planning, organizing, and overseeing the various aspects of a clinical research study. It involves managing a wide range of tasks, including study protocol development, participant recruitment, data collection, monitoring, regulatory compliance, budgeting, and timeline management.

Project management plays a crucial role in clinical research, ensuring the successful execution of studies and the generation of reliable and meaningful results.

The importance of project management in clinical research can be understood from the following perspectives:

Study Quality and Integrity

Effective project management helps ensure the quality and integrity of clinical research studies. Project managers work closely with researchers to develop robust study protocols, establish standardized procedures, and implement quality control measures. They ensure that the research is conducted in accordance with scientific standards, minimizing bias and increasing the reliability and validity of research findings.

Participant Safety and Ethics

Clinical research involves human participants, and their safety and well-being are of paramount importance. Project managers play a vital role in safeguarding participants’ rights and ensuring ethical conduct throughout the study. They ensure adherence to ethical guidelines, obtain necessary regulatory approvals, and implement protocols to protect participants from potential risks or harm.

Timely Execution

Clinical research projects often have strict timelines and deadlines. Effective project management ensures that studies progress according to the planned schedule, avoiding unnecessary delays. Project managers develop comprehensive project plans, identify critical milestones, and coordinate activities to keep the research on track. Timely execution is essential for the availability of research outcomes and potential interventions in a timely manner.

Resource Optimization

Clinical research projects require various resources, including personnel, funding, equipment, and facilities. Project managers play a vital role in resource management, ensuring that resources are allocated efficiently and utilized optimally. They identify resource requirements, secure necessary funding, coordinate personnel allocation, and make informed decisions to optimize resource utilization, ultimately maximizing the efficiency and cost-effectiveness of the research project.

Risk Management

Clinical research projects are subject to various risks and challenges that can impact the study’s progress and outcomes. Project managers proactively identify potential risks, assess their potential impact, and develop risk mitigation strategies. They implement measures to prevent risks or address them promptly if they arise. Effective risk management minimizes disruptions and ensures that studies proceed smoothly, thereby safeguarding the integrity of the research.

Collaboration and Communication

Clinical research involves collaboration among multiple stakeholders, including researchers, study coordinators, ethics committees, regulatory authorities, sponsors, and participants. Project managers serve as a central point of contact, facilitating effective communication and collaboration among these stakeholders. They ensure that all team members are well-informed, aligned with project goals, and working cohesively towards the successful execution of the research project.

Regulatory Compliance

Clinical research is subject to a complex regulatory environment, with strict guidelines and requirements. Project managers are responsible for ensuring compliance with applicable regulations and obtaining necessary approvals and permits. They stay updated with regulatory changes, coordinate with regulatory authorities, and ensure that the research adheres to ethical and legal standards. Compliance with regulations is crucial for the credibility and acceptance of research findings.

Stakeholder Management

Successful clinical research project management involves engaging and managing relationships with various stakeholders. Project managers collaborate with researchers, sponsors, ethics committees, regulatory authorities, and participants, among others. Effective stakeholder management builds trust, facilitates cooperation, and enhances the overall success of the research project. It also sets the foundation for future collaborations and research endeavors.

Project management is vital in clinical research to ensure study quality, participant safety, timely execution, resource optimization, risk management, collaboration, regulatory compliance, and stakeholder management. By applying project management principles and methodologies, project managers contribute significantly to the successful execution of clinical research studies, ultimately advancing medical knowledge and improving patient care.

Clinical Research Project Managers (CRPM) was established to bring together clinical research professionals who oversee activities in clinical research that utilize project management tools or methodologies to assist them in achieving project deliverables on time and on budget. CRPM aims to connect members of the clinical research project management (CRPM) community through online groups, in-person meet-ups, monthly webinars, and retreats that target the growth of CRPM’s network throughout the clinical research industry.

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What Does a Clinical Project Manger Do? Roles & Responsibilities

Clinical Project Managers (CPM) play a crucial role in advancing the progress of a clinical trial. The significance of CPMs lies in their ability to navigate complex clinical trials, ensuring precision, compliance, and efficiency.

As stewards of the entire research lifecycle, from planning to execution, Clinical Project Managers wield strategic thinking, leadership insight, and a deep understanding of regulatory landscapes.

In a world where the pursuit of groundbreaking therapies intensifies, the demand for skilled managers is reaching new heights, with organizations recognizing their pivotal role in trial success. 

This blog explores the pivotal responsibilities of clinical project managers and sheds light on why their expertise is becoming increasingly coveted, underscoring the crucial role they play in shaping the future of healthcare.

Table of Contents:

What is a Clinical Project Manager?

What does a clinical project manager do, skills required to become a clinical project manager.

• Essential Certifications or Degrees Required to become a Clinical Project Manager

How to Become a Clinical Project Manager?

Salary and job outlook for a clinical project manager.

A Clinical Project Manager (CPM) is an experienced expert in clinical research and healthcare management who is responsible for managing and coordinating the different aspects of clinical trials.

This multifaceted role encompasses strategic planning, execution, and monitoring of clinical research projects to ensure they adhere to regulatory standards, timelines, and budgets.

Clinical Project Manager acts as a connecting point between research teams, sponsors, regulatory authorities, and other stakeholders, facilitating effective communication and collaboration. 

Clinical Project Manager responsibilities include protocol development, risk management , team leadership, and navigating the complexities of regulatory compliance. By leveraging their expertise in project management, scientific understanding, and regulatory knowledge, they contribute significantly to successful clinical trials, ultimately advancing medical knowledge and bringing novel treatments to needy patients.

A Clinical Project Manager (CPM) is a pivotal figure in clinical trials, overseeing the intricate processes that lead to the successful execution of healthcare research. Their role encompasses many responsibilities, blending scientific expertise with project management skills to ensure the seamless progression of clinical trials.

Other key roles and responsibilities of a Clinical Project Manager:

• Strategic Planning: Develop comprehensive plans for the initiation, execution, and completion of clinical trials, aligning them with project goals and timelines
• Protocol Development: Contribute to the creation and refinement of study protocols, outlining the methodology, objectives, and criteria for participant selection
• Site Selection: Identify and evaluate suitable clinical trial sites, considering factors such as patient demographics, facilities, and regulatory compliance
• Regulatory Compliance: Navigate and ensure adherence to the complex web of regulatory requirements, obtaining necessary approvals and permissions for the clinical trial
• Budget Oversight: Manage the financial aspects of the clinical trial, ensuring adherence to the allocated budget and making informed decisions to optimize resource utilization
• Data Integrity: Oversee data collection and management processes, emphasizing the importance of data accuracy, completeness, and compliance with regulatory standards
• Problem Resolution: Address challenges and obstacles that may arise during the trial, making decisions that safeguard patient safety and ensure the integrity of the study
• Quality Assurance: Maintain a focus on the overall quality of the clinical trial, implementing measures to uphold ethical standards, patient welfare, and the reliability of research outcomes

Becoming a successful clinical project manager requires a diverse set of skills that combines scientific knowledge, project management proficiency, and effective communication. Below are some of the key skills that a clinical project manager is required to excel in the role:

1. Project Management Skills

• Planning and Organization: Ability to develop and execute comprehensive project plans, ensuring all aspects of the clinical trial are well-coordinated
• Time Management: Efficiently allocate resources, manage timelines, and prioritize tasks to meet project milestones
• Risk Management: Identify potential risks and proactively implement strategies to mitigate them, ensuring smooth project progression

2. Scientific Understanding Skills

• Clinical Research Knowledge: Familiarity with the principles and processes of clinical research, including study design, protocols, and ethical considerations
• Medical Terminology: Ability to understand and interpret medical and scientific terminology crucial for effective communication with research teams and stakeholders

3. Communication Skills

• Interpersonal Communication: Build strong professional relationships with diverse stakeholders , including research teams, sponsors, regulatory authorities, and site personnel
• Presentation Skills: Effectively convey complex information clearly and concisely, verbally and in written form

4. Leadership and Team Management Skills

• Team Building: Foster collaboration and cohesion within cross-functional teams, inspiring motivation and commitment to project goals
• Decision-Making: Make informed decisions promptly, especially in high-pressure situations, to address challenges and keep the project on track

5. Regulatory Knowledge and Skills

• Regulatory Compliance: Stay updated on and ensure adherence to relevant regulations and guidelines governing clinical trials in different regions
• Ethical Considerations: Understand and navigate the ethical considerations in clinical research, prioritizing patient safety and welfare

6. Problem-Solving Skills

• Critical Thinking: Analyze complex situations, identify root causes of issues, and develop effective solutions to keep the project moving forward

7. Financial Acumen

• Budget Management: Proficiency in managing project budgets, optimizing resource allocation, and ensuring financial accountability throughout the trial

8. Adaptability Skills

• Flexibility: Navigate unforeseen challenges and changes in project scope with adaptability, adjusting strategies and plans as needed
• Learning Agility: Stay abreast of advancements in clinical research, project management methodologies, and regulatory requirements

Essential Certifications or Degrees Required to Become a Clinical Project Manager

Becoming a Clinical Project Manager requires a combination of education, relevant degrees, and professional certifications. The specific requirements may vary based on the employer, industry sector, and the clinical trials complexity.

Here are some essential certifications and degrees that can enhance the qualifications of individuals aspiring to become Clinical Project Managers:

1. Educational Background

• Bachelor’s Degree: A bachelor’s degree in an appropriate field such as life sciences, healthcare, nursing, pharmacy, or a related discipline is frequently the minimum educational requirement
• Advanced Degrees: While not always mandatory, having a master’s degree (e.g., Master of Public Health, Master of Science in Clinical Research) or a Ph.D. can be advantageous, especially for more senior or specialized roles

2. Project Management Professional (PMP) Certification

The PMP certification is offered by the Project Management Institute (PMI), is widely recognized, and demonstrates proficiency in project management principles. It is valuable for Clinical Project Managers as they oversee complex clinical trials.

Achieve global recognition with the PMP certification from Invensis Learning. Benefit from expert trainers, flexible learning options, and success guarantees to propel your career to new heights. Enroll now to access exclusive discounts and become a certified leader in project management.

3. Certified Clinical Research Professional (CCRP) Certification

The Certified Clinical Research Professional (CCRP) certification is a professional designation offered by the Society of Clinical Research Associates (SoCRA). It is a worldwide recognized credential that demonstrates an individual’s skills and understanding of the principles and practices of clinical research.

4. Project Management Fundamentals (PMF) Certification

The Project Management Fundamentals (PMF) Certification is an entry-level credential offered by the Association for Project Management (APM) that validates an individual’s understanding of the fundamental principles and practices of project management. It is designed for those new to the field or wanting to formalize their project management knowledge.

5. Certified Clinical Project Manager (CCPM) Certification

The Certified Clinical Project Manager (CCPM) certification is a professional designation offered by various organizations that demonstrates an individual’s expertise in managing clinical trials and research projects. It validates their ability to effectively plan, execute, monitor, and evaluate clinical research studies, ensuring adherence to regulatory and ethical guidelines.

Becoming a Clinical Project Manager involves a strategic combination of education, experience, and professional development. Here’s a step-by-step guide on how to embark on a career as a Clinical Project Manager:

1. Get a Bachelor’s and a Master’s Degree

Embark on your journey by earning a bachelor’s degree in a relevant field, such as life sciences or healthcare. This foundational step equips you with essential knowledge for a career in clinical research.

To enhance your qualifications further, pursue a master’s degree, opting for specialized programs like a Master’s in Public Health (MPH) or a Master’s in Clinical Research.

2. Opt for an Entry-level Clinical Job

Kickstart your career with an entry-level position in clinical research, such as a Clinical Research Assistant or Coordinator. These roles expose you to the day-to-day operations of clinical trials, providing valuable insights into research protocols, data management, and regulatory compliance.

3. Gain Clinical Research Experience

Actively seek hands-on experience in clinical research, engaging in tasks like patient recruitment and study coordination. Develop a strong understanding of Good Clinical Practice (GCP) guidelines and ethical considerations. This practical experience lays the groundwork for a well-rounded skill set and prepares you for more advanced roles.

4. Build a Strong Resume

Create an effective resume that highlights your educational background, relevant coursework, and practical experience. Emphasize key skills such as attention to detail, data management, and knowledge of regulatory standards. Include certifications, like GCP, to underscore your commitment to maintaining high-quality standards in clinical research.

5. Find a Position as a Clinical Project Manager

Progress in your career by applying for roles with increasing responsibilities, focusing on project management within clinical trials. Leverage your educational background, practical experience, and certifications to showcase readiness for a Clinical Project Manager role. Highlight your ability to lead teams, manage timelines, and strictly adhere to regulatory standards.

Before switching any career, individuals should know two main things: one is salary growth and the other one is job opportunities. The salary and job outlook for a Clinical Project Manager (CPM) can vary based on factors such as experience, education, location, and the specific industry within healthcare or clinical research. It’s essential to note that salary trends and job outlook may evolve over time.

Salary of a Clinical Project Manager

The salary prospects for a clinical project manager are generally quite positive. They play a crucial role in the healthcare industry, overseeing the planning, execution, and monitoring of clinical trials and research projects.

Their expertise in project management, clinical research methodology, and regulatory compliance ensures the successful completion of these studies, leading to the development of new drugs, treatments, and medical devices.

Experience is a significant factor in determining salary. The salary ranges for clinical project managers are as follows:

Clinical project managers have the potential to experience significant salary growth throughout their careers. With increasing experience, specialized skills, and advanced certifications, clinical project managers can advance into senior-level positions with higher earning potential.

Additionally, the demand for clinical project managers is expected to grow faster than average in the coming years, further contributing to positive salary prospects.

Job Outlook of a Clinical Project Manager

The job outlook for clinical project managers is exceptionally promising, driven by the increasing demand for clinical trials, the growing complexity of research projects, and the expanding healthcare needs of an aging population.

As per the US Bureau of Labor Statistics (BLS) , employment of medical and health services managers, which includes clinical project managers, will expand by 32% from 2020 to 2030, much faster than the average for all professions. This growth is related to the aging population and the increasing demand for healthcare services.

Here are some specific factors that contribute to the positive job outlook for clinical project managers:

• Increasing demand for clinical trials
• Growing complexity of clinical trials
• The aging population and rising healthcare needs
• Expansion of medical group practices

Clinical project managers can pursue diverse career paths and advance into senior-level positions with increasing responsibilities and higher compensation.

Some potential career trajectories include:

• Clinical Research Associate (CRA)
• Clinical Research Coordinator
• Clinical Research Manager
• Director of Clinical Research
• Clinical Research Program Manager
• Clinical Research Portfolio Manager
• Clinical Project Manager Specialist
• Clinical Project Manager Lead
• Global Clinical Project Manager
• Senior Clinical Project Manager
• Executive Clinical Project Manager

A clinical project manager plays a pivotal role in the healthcare industry, ensuring the successful execution of clinical trials and research projects. Their expertise in project management, clinical research methodology, and regulatory compliance is crucial for bringing new drugs, devices, and therapies to patients, improving healthcare outcomes, and advancing medical knowledge.

If you are passionate about healthcare, have strong organizational skills, and possess a keen eye for detail, a career as a clinical project manager could be a rewarding and fulfilling path. With the right education, experience, and certifications, you can significantly impact the future of healthcare by overseeing the development of life-saving treatments and technologies.

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Project Management: Introduction to Tools and Templates

By: melissa harris, mpa, ccrp director of interventional resources & clinical trials unit pennington biomedical research center at lsu.

Abstract: Project management involves many complex components and moving parts. Prior to initiating a clinical trial, various types of project tools and templates can be used to successfully plan and execute a clinical trial. This article highlights tools that are readily available for project management, including Microsoft Excel, Access, Visio, Outlook, and SharePoint, as well as Web-based applications. Monitoring progress through various tracking mechanisms ensures successful clinical trial execution from recruitment through retention and follow-up.

Project Management

The project management life cycle for clinical trials is comprised of:

• Study start-up
• Team management
• Clinical assessment
• Intervention.

The project management tools covered in this article are described in relation to the project management life cycle. Examples are from clinical trials in academia; however, the tools can be used in any research setting.

At any given time, the project manager is shuffling plates and trying not to drop one. Project management can be considered similar to riding a bike. The project manager should be able to get on the bike or project and do the same thing on each ride, or in this case, from research project to research project. Unfortunately, in clinical research, the bike is “on fire,” the project manager is “on fire,” and everybody working on the clinical trial is “on fire.” This article provides tools to help douse the fire and continue to move forward on the research project. 

There are many components of a study, from the research idea through analyzing the data and publishing results (Table 1). The most difficult parts of a project are study start-up and keeping the study going when recruitment is not going well. The project manager and study team try to complete the first four components of a study (research idea, protocol, grant, and institutional review board review) in as compacted an amount of time as possible. Sometimes this requires having a very strong foundation. Tools and processes can be rotated from study to study, enabling the project team to move through the cycle fairly quickly.

The clinical trial lifespan includes:  

• Trial initiation and timeline management
• Creating and managing the budget
• Protocol/consent preparations, institutional review board (IRB) submissions, and revisions
• Development of processes and the manual of procedures (MOP)
• Liaison for contracts, subawards, and community partnerships
• Identifying and managing resources (staffing)
• Training/certification plans and tracking
• Ongoing communication and clinical trial oversight.

Tools help project managers calm the chaos of clinical trials. There are many project management tools, including:

• Microsoft Office Excel, Word, Access, Outlook, and SharePoint

Office 365 is not covered in this article, outside of Outlook, however, Office 365 offers a multitude of online apps.

Tools for Study Start-up

Tools for study start-up include organizational charts, timelines, and process flows (Table 2). A research program organizational chart documents a clear chain of command. It can create camaraderie and outlines responsibilities so that staff know to whom to report. The organizational chart also identifies people who have specialized positions, such as blinded staff. Visio is an easy tool to use in developing organizational charts.

Timelines provide milestone time points for various stages of start-up to be completed. They are crucial and should be revised constantly to align with the pace of the study. When developing a timeline, the author starts with the expected date of the first randomization or site activation and works backwards. The timeline maps the amount of time necessary for each step involved in study start-up. The timeline establishes clear goals for study staff so that each staff member knows the due date for assigned tasks.

Process flows, also known as flowcharts, allow a process and the steps in the process to be viewed at a glance. The author uses flowcharts for all extensive processes within a protocol, investigator brochure, or manual of procedures. It is much more efficient to refer to a flowchart when working with a study participant or working on other study tasks than to have to pull out a large document and search for the necessary information. 

Cross-functional flowcharts, also known as swim lanes, demonstrate the process steps in sequential order and show who does each task. Decision channels (yes/no) can also be included in a cross-functional flowchart.

The cycle of implementing the project and maintaining it is extremely important. Implementation must constantly be re-evaluated to determine whether it is working. A project may be working; however, it could be more efficient. Without monitoring, the project manager will never know if project efficiency could be improved. Monitoring includes identifying inefficiencies, assessing the cost-benefit ratios, and monitoring expenses against the budget.

Tools for Team Management

Team management is a major component of running a clinical trial. The author spends much of her day reading emails from people who are updating her on the work that they are doing on a study. This makes it difficult for her to accomplish her tasks for that day. Regular team meetings are an important form of communication. Team meetings can minimize the need for many emails. They can be done electronically, through teleconferences, Web conferences, online reporting systems, etc.

Effective team management also requires ongoing communication with internal affiliates (other departments) and external affiliates (community partners). A 10-minute telephone call twice a month may be sufficient to communicate with internal and external affiliates. Ongoing communication on the study’s outcomes/progress is also necessary with regulators, funders, and other external affiliates.

Document libraries, calendars, and action items are good tools for team management (Table 3). Document libraries provide a central location for all departmental or project-specific files. They may be housed on shared drives such as Google drives or Dropbox. Since these shared drives do not comply with the Health Insurance Portability and Accountability Act, some universities do not allow their use. Universities often use tools such as SharePoint, OneDrive, and Basecamp, which staff can access from anywhere. A document library automatically backs up the documents every night. 

Basecamp allows the project manager to set up study teams and provide different levels of access to documents for different team members. Assignments, schedules, and bookmarking of certain materials can also be done using Basecamp. In SharePoint, the project manager can create folders and list documents. SharePoint and Basecamp both track edits to documents.

Project managers and study staff use calendars, such as Outlook, extensively for scheduling appointments or responsibilities, participant scheduling, and study-specific calendars. Appointment reminder alerts are a key benefit of calendars. The author maintains a personal calendar and a department calendar to oversee staff activities via a central destination to book participant visits and other study related meetings. 

The department calendar is color-coded so that people can easily see the type of visit: green for assessment visits, purple for remote data monitoring, and yellow for phone call visits to name a few examples. Red indicates something important, such as not scheduling participants for visits requiring online RedCap surveys on a day that Internet access will be shut off or when the center will be closed. Calendars also show when staff will be out of the office. Patient identifiers and notes can also be put into calendars so that staff can reference the invite for patient information.

Action items are a key component of team management. Pennington Biomedical Research Center does action items with the Interventional Resources Unit for administrative activities and study specific tasks for every study. Action items clarify tasks to be completed by members of the study team. Each action item is associated with a responsible person and the deadline. If study team members cannot meet their deadlines, they need to notify the author because her deadlines are contingent on team members meeting their deadlines. Action items also increase accountability by providing clear expectations. 

Using SharePoint, the responsible staff member can update action items as she/he completes them so that the author does not to have to receive emails documenting this. SharePoint can also send notifications, emailing a staff member when she/he is assigned to a task. SharePoint can be used to prioritize tasks. This author has experienced a major challenge with Generation X and Z team members is who may have difficulty prioritizing. In the author’s experience, these generations may more often work on the last task assigned to them instead of the most important task.

Tools for Recruiting

Recruitment is the costliest part of clinical trials. Table 4 highlights tools for recruitment:

• Advertising timeline
• Recruitment goal tracking
• Recruitment budget tracking
• Participant flow diagram 
• Enrollment predictions.

The author develops an advertising timeline that is separate from the overall study timeline. The advertising timeline has recruiting and advertising tasks, with color coding for tasks that have been completed, and yield rates of completed events. Pennington Biomedical Research Center does a great deal of community-based recruitment. The yield rates (number of participants randomized) of completed events show the most effective recruitment methods for each quarter or year. This enables staff to repeat the most effective recruitment methods. 

Tracking recruitment goals is very helpful. Many of the clinical trials conducted at Pennington Biomedical Research Center are funded by the National Institutes of Health (NIH) or another government agency or department. These trials have quarterly recruitment goals. The author usually uses more aggressive goals than the NIH’s goals, since it is easier to recruit participants earlier in the grant when the project is novel and exciting to potential study participants that may be reached during the recruitment process.

Achieving recruitment goals requires providing the study team with clear expectations. Tracking enables project managers to assess monthly/quarterly randomization goals to see when the clinical research site was most successful and to identify effective recruitment methods that can be used again.

Tracking spending on recruitment is also helpful. The most expensive recruitment methods, such as television and radio advertising, may not be providing the most participants. Tracking spending and sources of participants enables the project manager to assess the cost effectiveness of advertising campaigns and adjust them as needed. Pennington Biomedical Research Center has different departments for recruitment and advertising. The departments have designated budgets over the study year yet coordinate marketing and outreach activities to maximize recruitment reach. 

The participant flow diagram is one of the author’s most important tools. A participant flow diagram tracks what is happening in real time, allowing project managers to see where participants are in any part of the study flow. It also lets study team members see when potential research participants and enrolled participants are lost due to exclusionary criteria or dropouts. A participant flow diagram documents the ratio of phone screens to randomization and the number of participants in the pipeline.

Screening yields can also be reviewed through the participant flow diagram. Pennington Biomedical Research Center always assesses why the clinical research site is losing potential subjects. This sometimes enables the project manager to make changes. For example, by tracking screening yields, Pennington Biomedical Research Center has found that people were being excluded from a study in the phone screen because they did not understand a question. In response to this problem, the question was clarified. Enrollment predictions can also be done with a participant flow diagram, and the pending pipeline can be assessed. Finally, retention rates can be assessed with the same diagram by looking at the number of completed, anticipated, and pending visits at each follow-up time point. This could allow for the project manager to identify whether a particular follow-up visit is problematic in return rates for study participants. This could lead to more intensive staff contact for said visits to work to improve these rates for future visit windows.

Tools for Clinical Assessment

Electronic case report forms (CRFs), visit scheduling, and visit windows are tools for clinical assessment (Table 5). The world is moving toward electronic CRFs. Some sites and PIs may be reluctant to eliminate paper especially with specific clinical trial populations such as the elderly. However, technology is moving clinical and research practices towards paperless data entry. In this author’s experience, many industry and pharmaceutical clinical trials are paperless or at least using electronic data capture options in many of their trials.

RedCap, built at Vanderbilt University, is a secure Web application for electronic data capture. Various levels of access can be set up for different staff members. Participant self-reported forms captured via surveys are part of RedCap. These surveys can be sent by email. Rather than call participants to collect information such as adverse events and weight, RedCap can send out automated emails on a timer to collect this information. Pennington Biomedical Research Center sets these up in advance and only has to contact participants when they do not complete the surveys.

Visit scheduling windows can be set in various electronic platforms. Pennington Biomedical Research Center uses Outlook or Sharepoint for visit schedules for some trials. The visit schedules show the start and stop time, preventing double booking of staff. If the visit includes laboratory testing, the system can send an alert to the laboratory with an appointment reminder. RedCap also does visit scheduling. The visit schedule can be printed for study participants or for the study folder.

Tools for Intervention 

Real-time data capture, adherence and compliance reporting, and retention tracking are tools for intervention (Table 6). Pennington Biomedical Research Center does many large multi-site exercise clinical trials or trials with many participants. In one study, 300 participants came to the center three times a week. Instead of writing all of the exercise prescriptions and data capture on paper, staff created the Exercise Database for Intervention (EDIN) to capture the exercise data in real-time using laptops on rolling carts. iPads can also be used to collect data in real time.

With real-time data capture, the data are automatically entered into a website or clinical trial management system. Real-time data capture also allows compliance reports to be generated instantly.

Other data capture tools include Fitabase, heart rate monitors, and body trace scales. When Fitbits are used in a study, its Fitabase can be used to look at data for all participants together. Fitabase provides more data than the data that are available on the app. Participants do need to sync their Fitbits in order for researchers to use Fitabase. 

PolarÔ Heart Rates Monitor and Zephyr can be used to monitor heart rates, including monitoring the heart rates of a group of people at once. Body trace scales are sent home with the participants, where they transmit weight wirelessly to Pennington Biomedical Research Center. Study staff can review trends and share individual data with each participant.

Adherence and compliance reporting is necessary because it is important for participants to stay in the study and to comply with the intervention. Project managers and study teams need to monitor compliance. Pennington Biomedical Research Center extracts adherence and compliance information and puts it in a format that will resonate with investigators. Staff create monthly or weekly participant compliance reports depending on the speed of the study. These reports can show what is happening between groups or within a group. 

Since all of the information is in the system, staff can generate reports for participants such as score cards or report cards. Participants often enjoy receiving these reports. If a participant is not doing something well, this is an opportunity for study staff to discuss any challenges and ways to overcome those challenges.

In order to facilitate intervention retention, Pennington Biomedical Research Center does case assessment to identify thresholds for adherence or compliance. Any participant who reaches the threshold for poor compliance is assigned to a study staff member who acts as a case manager and troubleshoots problems.

Staff also assess reasons for poor compliance to identify trends. They adjust screening and/or retention methods based on assessment results. 

The author is often asked how Pennington Biomedical Research Center tracks contacts with research participants. It is important to know why participants miss visits and the number of times that study staff call them. Clinical research sites must have a retention/participant contact system in place such as a SharePoint list. Pennington Biomedical Research Center’s retention/participant contact system lets the author see the visit window and when to call. She assigns a study staff member to call participants on the specified dates.

Take-Home Messages

Clinical research sites should not rely solely on the successes or failures of past programs or models. It is often necessary to tailor tools to a specific study. In order to be successful over time, clinical research sites must establish:

• A strong infrastructure
• Clear operational procedures
• A variety of tools to monitor research programs, study teams, and research participants. 

Continual evaluation and revision of the research program is necessary. If something works very well, keep doing it. If something does not work, reevaluate it and shift to a more effective strategy. Project managers and study staff must be willing to adapt and change. Some study staff members may require more micro-management than others. The author uses electronic platforms to manage study staff, which is less confronting than managing them face to face. 

Project managers should create a versatile study team that matches the needs of the research program and has a great deal of information. Team members will be different. Some may be very technologically savvy while others may not be technologically savvy.

Increasing efficiencies by saving minutes a day does matter. This can reduce staff burden, burnout, and turnover. Project managers and study staff should work smarter, not harder.

Study Components 

• Choose a topic
• Create a hypothesis
• Develop a plan
• Submit a grant for funding
• Submit the protocol for approval
• Market the study to the target population
• Screen potential participants by telephone
• Orient participants
• Obtain informed consent
• Inclusion/exclusion criteria
• Compliance assessment
• Perform initial assessments 
• Conduct study group
• Monitor progress 
• Test outcomes for changes 
• Prove/disprove hypothesis
• Assess outcomes
• Publish findings 
• Outlines chain of command
• Outlines responsibilities
• Helpful for all study staff to appreciate where they fall and where other’s fall
• Provides pre-identified time points for completion of various stages of start-up 
• Establishes clear goals for study staff
• Ever-changing with the pace of the study
• Also known as flowcharts
• Allows process and steps to be viewed at a glance
• Identifies actions within a process in a sequential order
• Provides specifics of process steps with relevant “if, then” scenarios
• Central location for all departmental or project-specific files
• Increases accessibility 
• Increases dissemination of information
• Archived history of all documents, processes, data, etc.
• Document security with automatic nightly backups
• Staff scheduling for designated appointments or responsibilities
• Participant scheduling for appointments or procedures
• Study-specific calendar for meetings, visits, etc.
• Clear assignment of staff to participant visits
• Appointment reminder alerts
• Ease of identifying other staff members’ availability
• Reduces double booking staff and appointments
• Color coding to easily identify appointments
• Clarify tasks to be completed by the study team
• Provide study team pending action items with associated deadlines
• Assign actions items to designated staff
• Increase accountability through clear expectations

Tools for Recruitment

• Timeline of recruitment and advertisement events
• Yield rates of completed events
• Identify and track study recruitment requirements
• Assess monthly/quarterly randomization goals
• Monitor progress
• Adjust advertising campaigns as needed
• Identify and track study recruitment budget
• Assess cost effectiveness of advertising campaigns
• Determines screening yields
• Assess where participants are lost due to dropouts or exclusionary criteria
• Determine ratio of phone screens to randomization
• Stage of the process for pending participants
• Management of N in each arm of the trial
• Follow-up visit completion rates
• Assess pending pipeline
• Use throughput rates to predict enrollment
• Predict quantity needed to reach goals
• Paperless electronic data capture systems
• Participant self-reported forms captured via surveys
• Auto-generated timed survey requests for completion
• Calculated visit windows for follow-up testing
• Tracking scheduled and actual visit dates
• Pending visit reports

Tools for Intervention

• Real-time data
• Easily accessible compliance reports
• Assess participant compliance monthly
• Identify discrepancies and any areas of concern
• Generating reports for participants
• Tracking participants’ attendance and reasons by the individual, group, cohort, month, etc.
• Tracking retention procedures
• Tracking contact attempts during dropout recovery

2 thoughts on “Project Management: Introduction to Tools and Templates”

where is the tools template？

Hey, fellow readers! I just finished reading the article on project management tools and templates, and I couldn’t resist leaving a comment here. First off, I want to thank the author for putting together such a comprehensive and informative piece. As someone who’s relatively new to the project management world, this article was like a goldmine of practical tips and resources.

The way the author explained various project management tools, from Gantt charts to PERT diagrams, was incredibly helpful. I always found these concepts a bit overwhelming, but the article managed to break them down into digestible chunks, making it easier for me to understand their applications. The best part is that they provided links to free templates and software, which is a lifesaver for anyone on a budget.

Moreover, the insights on how to choose the right tools for different types of projects were enlightening. Understanding that not all projects are the same and tailoring our approach accordingly is crucial for success. I’ve already bookmarked this article for future reference and plan to explore the recommended tools further.

Lastly, I want to express my gratitude for the tips on how to collaborate effectively with teams using these tools. As a project manager, fostering good communication and collaboration is essential, and the author’s suggestions will undoubtedly prove invaluable in my journey.

Great job on this article! I can’t wait to dive deeper into project management armed with these newfound knowledge and resources. Keep up the fantastic work, and I’ll be eagerly awaiting more insightful pieces from this blog. Cheers!

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Home / Insights / Project Management Framework and Tools in Clinical Trials

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Project Management Framework and Tools in Clinical Trials

September 29, 2020

Project management’s maturity as a discipline has had wide-reaching effects across most industries.

It’s changed the way people manufacture products, develop software, plan company strategies — and even how clinical trials are conducted.

Here, we explore how the evolution of project management has impacted clinical research, and what aspects of project management trial leaders need to know to be successful.

Meet Your Clinical Project Manager

Because clinical trials have so many stakeholders and moving parts, it makes sense that someone should take responsibility at a project level.

As Genesis Research Services Business and Clinical Research Manager  Dom Bailey  points out, this person — the clinical project manager — is responsible for explicitly laying out the project objectives, scope and stakeholder management plan.

Additionally, the project manager will work with a CRO’s leadership team to ensure things like sufficient recruitment numbers and that the necessary project management tools are in place.

Dalfoni Banerjee  at 3Sixty Pharma Solutions says a good clinical project manager must be able to plan and establish key metrics, communicate very well, and remain oriented on the project’s goals while maintaining flexibility to accommodate any unexpected changes.

For trial leaders, perhaps the most important trait in a project manager is their communication skills. “Nothing is worse than working for an out-of-touch project manager—someone who is lost in the project plan or the study metrics, or making assignments without listening or making any kinds of assessments or mid-course corrections,”  Jim Moat  at IMARC Research writes.

“Someone with a balanced view of the big picture and the smaller, but important, details, is bound to lead a more successful project and team.”

Moat underscores how important relationships are in managing a trial, which means a good PM knows how to listen and is willing to spend time with research staff to understand realities on the ground.

Zain Asad, M.D., and Kat Niewiadomska, Ph.D. , write for the American College of Cardiology that their own experience with project management made them better team members. The PM perspective allowed them to see how each person complemented others and fit into a cohesive team.

The Rising Influence of Agile Project Management in Clinical Trials

Nearly 20 years ago, the  Agile Manifesto  laid out a new framework for developing software by making the production process iterative and dynamic.

Today, that methodology has found purchase across industries, and its principles are nudging clinical project management into new directions.

Most clinical project managers apply agile frameworks in an effort to cut costs and improve efficiencies. That said, aspects of agile such as iterative development and regular opportunities for stakeholder feedback create other opportunities in clinical trials.

As  Syneos Health  notes, an agile approach to clinical trial management can:

• Break up siloed teams and facilitate cross-functional cooperation.
• Upend linear business processes and replace those with opportunities to innovate.
• Center stakeholder needs.
• Facilitate “early and proactive dialogue with regulators to support expedited pathways for bringing new products or innovation to market.”

As promising as that all sounds, though, agile’s uptake has been stifled on a few fronts. In a 2018 dissertation for Harrisburg University of Science and Technology,  Jitendrakumar Narola  surveyed nearly two dozen healthcare IT professionals about their experience with agile projects in clinical trials.

Narola’s research found that many respondents were hesitant to embrace an agile approach to project management because they didn’t feel sufficiently familiar with the framework, or because they weren’t sure how compatible it would be with FDA regulations.

Further, agile transformations are more fundamental undertakings than simply tweaking how a project is managed. “[A]gile methodology is not applicable neither to all parts of a study nor to all kinds of studies, but striving for an agile transformation in an organization as a whole will pave the way in making clinical trials as ‘adaptive’ as possible,” researchers  Katarina B. Pavlović, Ivana Berić and Ljiljana Berezljev  write in the European Project Management Journal.

This, of course, speaks to a larger movement among researchers who lean on  adaptive trial designs  to make data collection and analysis concurrent during an in-progress trial.

The Tools Shaping Clinical Project Management

The fundamental tasks of project management are the same, no matter the industry or the project.

A clinical project manager will specifically need a tool to help with:

• Creating the work breakdown structure.
• Analyzing and mitigating risks.
• Planning budgets.
• Determining milestones and key metrics to track.

This is the kind of work that can be done in a  clinical trial management system  (CTMS). A CTMS should give you space to organize an electronic trial master file (eTMF), which is absolutely crucial in what Jim Moat at IMARC describes as “telling the story of your study.”

“Ensure your trial master file is kept current and complete,” he writes. “ … Make judicious use of notes-to-file and memos to document unusual steps taken in a given situation. As we say at IMARC, ‘you’ve done the work; now write it down to take credit for your work.’”

Further, ensure your CTMS allows you to share documents (or at least integrate with a tool like  Microsoft SharePoint , which facilitates document collaboration), and that it provides a place to track timelines and milestones.

From there, a project manager might opt for a separate project management platform that accommodates their preferred methodology. For example, a tool like  Asana  or  Microsoft Project Manager  can help visualize timelines, budgets and tasks.

Or, if the project manager needs to organize work in a Kanban-style workflow, tools like  Trello  or  MeisterTask  can help visualize those tasks.

Finally, a project manager needs to be able to host and lead meetings, sometimes with remote staff. In such cases, a conferencing tool like  Zoom  or  GoToMeeting  would be useful.

With the tools above and a framework in place, a clinical project manager has what they need to try to steer a clinical trial toward its goals within budget and within expected timelines. Of course, no projects go exactly as planned, so transparency and communication go a long way to getting a trial back on track in the face of unexpected changes.

For clinical trial leaders, having this kind of perspective into the project-management aspects of a trial will be useful in marshalling resources and leading teams as needed.

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Project Stakeholder Management in the Clinical Research Environment: How to Do it Right

Seithikurippu r. pandi-perumal.

1 Department of Population Health, New York University Medical Center, New York, NY, USA

Sohel Akhter

2 Department of Management, Zicklin School of Business, Baruch College, New York, NY, USA

Ferdinard Zizi

Girardin jean-louis, chellamuthu ramasubramanian.

3 District Mental Health Programme, Madurai Medical College, Madurai, India

4 Division of Community Psychiatry, M. S. Chellamuthu Trust and Research Foundation, Madurai, India

R. Edward Freeman

5 University of Virginia Darden School of Business, Charlottesville, VA, USA

Meera Narasimhan

6 Department of Neuropsychiatry and Behavioral Science, University of South Carolina School of Medicine, Columbia, SC, USA

7 University of South Carolina, Columbia, SC, USA

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK ® of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article.

A true architect is not an artist but an optimistic realist. They take a diverse number of stakeholders, extract needs, concerns, and dreams, and then create a beautiful yet tangible solution that is loved by the users and the community at large. We create vessels in which life happens – Cameron Sinclair ( 26 )

In recent years, a revolution in thinking about organizational management and decision making has taken place. Increasingly, programs have been incorporated into organizations, typically private sector corporations or government agencies, which have sought to involve “stakeholders” in management decision making. Stakeholders are the customers, suppliers, the general public, and any other group, which are likely to be affected by the organization’s ultimate decisions. The process of incorporating the ideas and input from these groups has been termed “stakeholder engagement.” It reflects an increasingly accepted attitude that organizations not only have an ethical obligation to involve the participation of stakeholders in their collective activity but also in so doing their overall organizational effectiveness will be enhanced. While certain generalizations in the application of this philosophy are constant, minor variations also exist, which reflect the specific goals that the organization is pursuing. In this review, the application of stakeholder engagement in clinical research settings, particularly in hospitals or university research centers, is considered.

According to the Institute of Medicine (IOM), the purpose of comparative effectiveness research (CER) is, “to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve healthcare at both the individual and population level” ( 1 ). The Kellogg Commission report defines engagement as follows: “By ‘ engagement ’ we refer to institutions that have redesigned their teaching, research, and extension and service functions to become even more sympathetically and productively involved with their communities, however, community may be defined” ( 2 ). Hospitals and research centers are increasingly taking deliberate steps to include their broader constituencies in project management decision making and to seek their input at an early stage of the research or program implementation process. The term “ community engagement ,” can be defined as, “the process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the well-being of those people” [( 3 ), p.3]. It has been noted that traditional models of research which view study subjects or targets of program development as passive audiences may result in research findings that are poorly aligned with the information needs of real-world decision makers ( 4 , 5 ). An additional impetus for this interest has been the Patient Protection and Affordable Care Act of 2010, which was enacted to promote patient engagement. The purpose of the act has been to help patients, clinicians, purchasers, and policy makers make better informed health decisions by “advancing the quality and relevance of evidence about how to prevent, diagnose, treat, monitor, and manage diseases, disorders, and other health conditions.”

The key focus in the process of stakeholder engagement is of course the stakeholder. Freeman ( 6 ): 46 defined stakeholder as, “any group or individual who can affect or is affected by the achievement of the organization’s objectives.” According to the project management institute (PMI), the term stakeholder refers to, “an individual, group, or organization, who may affect, be affected by, or perceive itself to be affected by a decision, activity, or outcome of a project” ( 7 ). In other words, almost any individual or group of individuals with an interest or stake in a consensus-building process thereby the outcome of the project and/or an ability to exert a positive or negative influence by the execution or completion of a project or being affected by the work or its deliverables, outputs, or results.

In clinical research, researchers are often faced with questions about the choices that must be made by patients. Research can also be focused on assisting the process of program development. In either instance, the underlying motivation remains the same: to healthcare delivery, to become aware of dysfunctionalities that may exist in healthcare, and to improve the outcomes of proposed changes. It is essential then that research and program processes are assisted by those who are most directly affected by proposals, i.e., the patients themselves. Central to the process of encouraging stakeholder involvement therefore is a basic assumption that patients have the right to make the best decisions about their own health care.

Stakeholder engagement versus stakeholder management (ShM): in recent years, the term “ stakeholder engagement ” (ShE) has become widely used in applied clinical research and new program development. An important reason for this is that it has been repeatedly shown that critical health issues, which are often known to the patients or research subjects themselves, may not have been addressed in the original research or program proposals ( 8 ). Stakeholder engagement is a bidirectional process. It begins when the researcher communicates and interacts with stakeholders, and ultimately results in informed decision-making concerning the selection, conduct, as well as dissemination of research findings in order to achieve a desired outcome and enhance accountability ( 9 , 10 ). Stakeholder engagement is thus differentiated from one-way communication processes that seek to influence groups to agree with a decision that has already been made.

The obligation to serve all stakeholder interests is often called stakeholder management ( 11 , 12 ). The main distinction between stakeholder management and stakeholder engagement largely rests on the extent to which stakeholders are involved in the decision-making processes. The process of engagement varies across different research programs, but is highly noticeable in complex, multidisciplinary research.

A stakeholder analysis is a process, which provides insights into, and understanding of, the interaction between a project and its stakeholders. In other words, the process of listing, classifying, and assessing the influence of these stakeholders in a project is termed a stakeholder analysis. Stakeholder analysis systematically gathers and analyzes both qualitative and quantitative information thereby to determine whose interest should be taken into account throughout the project. One of the first tasks that a clinical project manager must undertake is to identify how stakeholders can make the greatest impact on the research project or program change, which is being contemplated. The function of stakeholder analysis is to produce an awareness of who will be affected by the project and who can contribute to making the project more successful. The stakeholder analysis, which is usually undertaken at an early stage of planning, is an integral part of risk and reward assessment activities.

It is essential for maximal project effectiveness that managers be committed to the basic philosophy of stakeholder involvement. Project managers must communicate and impart what they see as their goals but also seek to encourage participation by stakeholders so that their perspectives are included in decision making.

The process of identifying, engaging stakeholders must begin well in advance so that dialog is seen to play an important part of project implementation; no decisions should be already made before commencing stakeholder engagement on project-related issues.

Benefits of Stakeholder Engagement

Well managed projects, although long and complex, create long-term economic gain and social values meaning that proper use of taxpayer’s money. When done correctly, stakeholder engagement provides opportunities to further align clinical research practices with societal needs, values, and expectations, helping to drive long-term sustainability and stakeholder interests.

Stakeholder engagement is intended to help administrators fully realize the benefits of applying community and patient interest in hospital programs, and to ensure that research and program changes benefit those who are most directly affected.

The stakeholder focus group is a communication medium through which the opinions of individuals or groups of individuals who are impacted by the research can be elicited. Focus groups can also serve to clarify each stakeholder’s role and responsibilities, as well as promoting an overall understanding of the project requirements. Such processes also provide stakeholders with an environment in which they can express their opinions and feel that they have been heard.

In a series of related manuals the Patient-Centered Outcomes Research Institute (PCORI) ( 13 ) has provided a group of examples of how hospitals and medical clinics can encourage stakeholder involvement, in various research projects or programs whose aim was to improve the quality of medical services.

It can be seen from one of our case studies (see Appendix ) that stakeholders can make meaningful contributions to a project when opportunities are structured to encourage their participation. The process of encouraging stakeholder participation is referred to as stakeholder management.

Requirements for Stakeholder Management

Stakeholder management involves the processes of identifying (both internal as well as external) stakeholders; assessing stakeholders’ skills, knowledge, and expertise; determining stakeholders’ requirements; determining stakeholders’ interests and expectations; determining stakeholders’ communication needs; addressing stakeholders’ issues and concerns as they occur; maintaining a positive relationship and communicating with stakeholders throughout the project; identifying stakeholders’ influence-controlling strategies; making sure that stakeholders are involved in the project at the required level throughout the project; and confirming continuous interactions with the stakeholders. In the area of clinical research patients and other stakeholders such as physicians, clinicians, nurses, and others have critical roles to play. Clinical researchers at the outset of research need to ask for patient participation in the development of research questions. Researchers need to find out the exact characteristics of study participants and to define what the nature of the research outcomes should be. In this process, contributions from patients are helpful and often critically important for project success. The process of carrying out research also involves measuring the results of research interventions and monitoring the progress of the research, especially in terms of whether or not it is being directed toward the initial intentions of the research. Finally, patients, who are often very closely connected with the target populations of the research, have a direct perspective on how the targets of the research will respond to the research recommendations, and therefore, can provide useful inputs for insuring its relevancy.

Project Stakeholder Management Processes

The PMI identifies four key processes that are associated with the stakeholder management knowledge area in initiating, planning, executing, and monitoring and controlling process groups ( 7 ) (Table ​ (Table1 1 ).

Four project stakeholder management processes and key outputs .

Identify Stakeholders

This entails identifying all people or organizations impacted by the project and documenting relevant information regarding their interests, expectations, involvement, and influence on project success. In the hospital setting, the stakeholders are usually the patients, but can also be healthcare professionals and the families of patients. Examples of stakeholders are given in Table ​ Table2 2 .

The stakeholders can be categorized or classified in many different ways for different purposes .

For example, primary stakeholders (e.g., users of the products or services) or secondary stakeholders (they may not be the end users, however, have some other relationship) .

Throughout the project the following critical tasks should be carried out.

All internal and external stakeholders should be identified. These will usually be the patients but often will include the patients’ family members, healthcare providers, or program administrators.

Stakeholders’ interests, requirements, and expectations should be identified. Obviously, patients are interested in the effects of proposed program changes or research outcomes on their health and well-being, but may have additional interests such as hoping to improve their employment prospects, or expanding their range of capabilities. Clinical researchers and administrators should be alert to these concerns and take appropriate steps to address them. It has been found, for instance, that stakeholder views at the beginning of a program evaluation process may be provisional or may change as a result of additional information. Additionally, stakeholders’ interests may change over time. In one study, the results of pre-workshop and final workshop voting often differed, suggesting that prioritization efforts relying solely on requests for topics from stakeholder groups without in-person discussion may provide different research priorities ( 14 ). Thus, efforts should be made to audit the evolving nature of stakeholders’ expectations and preferences through structured methods.

All stakeholders’ levels of influence should be determined. It is often the case that patients and other beneficiaries of program development have talents and skills that may not be reflected in records of formal education or social standing. Certain personal traits, which patient stakeholders may possess, such as communication skills or life experience, could nevertheless prove invaluable for achieving project goals.

A communication plan for the stakeholders should be determined. Patient stakeholders may not always be familiar with or comfortable in using traditional channels of communication in large organizations. As noted by Lavallee et al. ( 15 ), the increasing availability of mobile technology, social media, internet venues, and electronic devices has multiplied the communication options for many, but carries with it the risk of increasing the quantity of participants while reducing the depth of involvement. Often, the use of focus groups or small informal meetings can be used to increase the quality of communication or to elicit participation from those who might otherwise be reticent about expressing their views. Reviews of methods of communication for engaging stakeholders have concluded that a combination of approaches probably yields the best results. Methods such as voting or using ranking procedures such as the analytic hierarchy process ( 16 ) and other structured techniques are best for establishing research priorities, whereas in-person methods are best for clarifying ideas and generating ideas ( 17 ). Repeated exposure to these experiences be useful for identifying patient stakeholders’ core concerns and for acclimatizing them to organizational communication.

Stakeholders’ expectations and influence over the project should be managed. Reality checks are important for balancing patients’ idealistic expectations and the necessity of dealing with the challenges of getting things done through institutions. Program administrators must identify patient stakeholders’ strengths and channel these for optimal organizational impact.

Depending on their complexity, size, and type, most projects have a diverse number of internal and external stakeholders at different levels of the organization with different authority levels.

Stakeholder identification is a dynamic and sometimes difficult process, and the influence of a stakeholder may not become evident until later stages of a project. And, sometimes projects evolve so that solving unseen problems emerges as a critical task. It is essential to identify as many as stakeholders as possible at the beginning of the project and classify them according to their level of interest, influence, importance, and expectations at the earliest stages of the project as much as possible (Table ​ (Table3). 3 ). The identification of the relevant stakeholders is not only a core necessity but also poses a significant challenge. For example, under cost constraints, it might not be possible to identify all external stakeholders ( 18 ). On the other hand, stakeholders who are missed out during the identification process might have special requests to be fulfilled. This could potentially delay the project completion or escalate the cost as their requirement needs to be fulfilled. Additionally, as Bryson ( 19 ) pointed out that the failure to attend to the information concerns of stakeholders clearly is a kind of flaw in thinking or action that too often and too predictably leads to poor performance outright failure or even disaster.

Stakeholder management strategy .

Project charter

The project charter gives an overall picture of the project as well as describing some of the stakeholders and their interest in the project along with their requirements.

Procurement documents

If a project is based on an established contract or the result of a procurement activity, the parties in that contract are key project stakeholders. Other relevant parties such as suppliers, legal parties, and people who will execute the contract should also be considered as part of the project stakeholders list.

Enterprise environmental factors

Hospital culture and structure, and other factors may influence the identify stakeholders process.

Organizational process assets

To benefit from previous experience those in charge of developing proposals should carefully review the efforts of earlier projects. The stakeholder register template, lessons learned, and the stakeholder registers from previous projects may influence the identify stakeholders process.

Stakeholder analysis

It is not possible to treat all stakeholders equally in the project, and they are given different priorities with respect to their interests, expectations, and influence on the project. Stakeholder analysis is a process of systematically gathering and analyzing all relevant quantitative and qualitative information about the stakeholders in order to prioritize them and determine whose interests should be taken into consideration throughout the project.

As per PMI, stakeholder analysis is performed by the following steps:

• Step 1: all potential project stakeholders and their relevant information, such as their roles, interests, knowledge levels, expectations, and influence levels should be identified.

Stakeholder mapping: the power versus interest grid . The gird shows stakeholders on a two-by-two matrix showing the strategies to be employed to engage and manage them. Power/interest grid model shows the grouping of the stakeholders based on their level of authority (“power”) and their level or concern (“interest”) regarding the project outcomes. Identifying and classifying the stakeholders is pivotal as it helps to develop appropriate strategies to effectively engage and manage all the stakeholders involved in a particular project. This also provides a clear-cut strategy and action-oriented and workable plan to interact with the all the stakeholders in an effective manner so as to minimize the resistance and maximize the support. A project is as successful as the stakeholders think it is. The details of power versus interest grids are found elsewhere ( 25 ).

• Power/influence grid: this is based on the level of authority or power and active influence a stakeholder has.
• Influence/impact grid: this groups stakeholders based on their involvement or influence and their ability to affect changes to planning or execution (impact).
• Salience model: this addresses a stakeholder’s power or ability to impose their will, urgency, or need for immediate attention from the team and legitimate involvement in a project.
• Step 3: in order to influence the stakeholders to enhance their support and to mitigate potential negative impacts, the way in which key stakeholders are likely to react or respond in various situations should be assessed.

Stakeholders who have greater power or influence and a strong interest in the project should be managed closely and continuously updated. Stakeholders who have significant power but low interest in the project should be kept informed about the project. Stakeholders who have low power and low interest should be monitored, and stakeholders who have low power and high interest should be kept satisfied.

Expert judgment

Judgment and expert opinions can be gathered to identify stakeholders, usually from the senior management. These resources can include project team members, project managers from similar projects, subject matter experts, industry groups and consultants, and other units within the hospital or research setting.

Profile analysis meetings with team members and the sponsor will be beneficial for identifying stakeholders and their knowledge, potential roles, importance, impact, interest, and expectations in the project.

Stakeholder register

This contains all details related to the identified stakeholders including but not limited to

• Stakeholder classification: stakeholders can be classified in many different ways. For example, primary (users of the products, services, or results) or secondary (may not be the direct users, but have some influential relationship), Internal/external, neutral/resistor/supporter/hard to hear, and so on.
• Identification information: name, title, location, organization, role in the project, position, and contact information.
• Assessment information: key requirements and expectations, potential impact, importance, and influence on the project.

A project manager may publish the stakeholder register with other project documentation or keep it in reserve for personal use only (Table ​ (Table4 4 ).

A snapshot of a stakeholder register: stakeholder register is a project document, which is an output of identify stakeholders process .

Stakeholder Register will be an important input to the plan stakeholder management process, as well as several other planning processes, which includes plan communication management. A stakeholder register may contain key information such as the identification, assessment, and classification of project stakeholders. A snap shot of stakeholder analysis to show how the stakeholders and their interest areas mapped onto a matrix. The stakeholder’s position might vary from a supporter (S); moderate supporter (MS); neutral (N); moderate resistor/opponent (MR or MO); and resistor/opponent (R or O). Identifying and analyzing the stakeholders are crucial for a project success .

Plan Stakeholder Management

The plan stakeholder management process defines an approach for managing stakeholders throughout the entire project life cycle as per their interest, impact, importance, and influence over the project. It defines the strategies for building close relationships with stakeholders who can benefit the project and for minimizing the influence of stakeholders who may have a negative impact on the project.

This process is iterative and should be reviewed on a regular basis as the required level of engagement of the stakeholders’ changes in the project.

Project management plan

Components of the project management plan (PMP) such as the human resource management plan, staffing management plan, communications management plan, change management plan, and others are used in developing the stakeholder management plan (SMP).

This contains all details related to the identified stakeholders, including identification information, assessment information, and classification.

All environmental factors within the hospital or clinical research facility, including its culture and history of the organization, are used.

All organizational process assets, especially lessons learned and historical information are used.

Judgment and expert opinions can be gathered from senior management, project team members, identified stakeholders, project managers from similar projects, subject matter experts, industry groups and consultants, other units within the organization, and other people to identify the level of involvement required from each stakeholder at various stages of the project. However, it is possible that expert judgment can be mistaken when possible expert judgment must be balanced with input from the stakeholders themselves.

Meetings with team members and the sponsor will be beneficial for identifying the level of engagement required from each stakeholder.

Analytical techniques

Various analytical techniques are used for identifying the required level of stakeholder engagement. These techniques take into consideration stakeholder sensitivity to project goals and personal orientations such as being unaware, resistant, neutral, supportive, or providing leadership.

Stakeholder engagement assessment matrix

The stakeholder engagement assessment matrix (SEAM) is used to assess the current and desired state of engagement of a stakeholder for the current phase of the project (Table ​ (Table5 5 ).

Stakeholder engagement assessment matrix (SEAM): please note that the current and desired engagement level of key stakeholders expect to change as the project progresses and develops .

C, current state; D, desired state .

The SEAM illustrates that only Stakeholder 4 is engaged in the project at the desired state. The project manager should consider additional communication and further actions to bring all other stakeholders to the supportive and leading states.

Stakeholder engagement is critical to project success; thus, required actions and communication should be planned to minimize the gap between the desired level of engagement and the actual level of engagement.

Stakeholder management plan

Stakeholder management plan, which is a subsidiary plan of the PMP that defines the processes, procedures, tools, and techniques to effectively engage stakeholders in project decisions and execution on the analysis of their needs, interests, and potential impact ( 7 ). The SMP can be formal, informal, highly detailed, or broadly framed based on the needs of the project. The SMP typically describes the following:

• information needs of each stakeholder or stakeholder group;
• stakeholder communication requirements;
• format, method, time frame, and frequency for the distribution of required information to the stakeholders;
• person responsible for communicating the information to the stakeholders;
• methods of refining the SMP;
• required engagement level of the stakeholders at various stages of the project;
• stakeholder management strategy that defines an approach to manage stakeholders throughout the entire project life cycle. It defines the strategies to increase the support of the stakeholders who can impact the project positively and minimize the negative impacts or intentions of the stakeholders who can negatively impact the project.

The portion of the plan that contains sensitive information such as stakeholders’ personalities and attitudes, negative impact that stakeholders may cause, or other factors is not usually published and is kept in reserve by the project manager for personal use only.

Project documents updates

Project documents such as the project schedule, stakeholder register, and others may be updated.

Manage Stakeholder Engagement

The Manage Stakeholder Engagement process is focused on meeting and exceeding the stakeholders’ expectations by continuously communicating with them, clarifying and resolving their issues, addressing their concerns, and improving the project performance by implementing their change requests.

As per PMI, the project manager is responsible for managing the stakeholders’ expectations. Meeting the stakeholders’ expectations increases the probability of project success by enabling the stakeholders to be active supporters of the project, drastically reducing unresolved stakeholder issues, and limiting disruptions in the project.

Within the research context, the SMP identifies information needs, communication requirements, required engagement level at various stages of the project, stakeholder management strategy, and other factors to identify and manage stakeholders throughout the entire project life cycle.

Communications management plan

The communications management plan is a subsidiary of the PMP. It can be formal, informal, highly detailed, or broadly framed based on the needs of the project. The communications management plan typically describes the following: purpose for communication; Information needs of each stakeholder or stakeholder group; stakeholder communication requirements; format, method, time frame, and frequency for the distribution of required information; person responsible for communicating the information; methods for updating the communications management plan; persons or groups who will receive the information; glossary of common terms; issues/concerns escalation procedures.

A change log is used to document changes that occur during a project. A lot of these changes can impact different stakeholder interests; thus, the change log is reviewed in this process.

Organization communication requirements, issue management procedures, change control procedures, and historical information are used.

Communication methods

According to the needs of the project, the methods of communication identified for each stakeholder in the communications management plan are utilized during the manage stakeholder engagement process.

Interpersonal skills

The project manager applies appropriate interpersonal skills or soft skills to manage stakeholder expectations by building trust and resolving conflict.

Management skills

Management skills such as presentation skills, negotiation skills, writing skills, and public speaking skills used by the project manager can greatly influence how stakeholders feel about the project.

An issue is an obstacle that threatens project progress and can block the team from achieving its goals. An issue log is a written log document to record issues that require a solution. It helps monitor who is responsible for resolving specific issues by a target date. There should be one owner assigned for each issue reported within the project.

Change requests

Change requests can include a new change to the product or the project, corrective or preventive actions, and other items.

Project management plan updates

The SMP portion of the PMP is updated as new stakeholders’ requirements are identified, existing requirements are changed, or as a result of addressing concerns and resolving issues of the stakeholders.

Project documents that may be updated include, but are not limited to, the following:

• Issue log: this will be updated as resolutions to the current issues are implemented and new issues are identified.
• Stakeholder register: this is updated as stakeholders’ statuses change, new stakeholders are identified, registered stakeholders are no longer involved or impacted by the project, and other factors.

Organizational process assets updates

Lessons learned from managing stakeholders, feedback from stakeholders, project records, causes of issues, and reasons for corrective actions chosen may be updated.

Control Stakeholder Engagement

The control stakeholder engagement is the process of evaluating and monitoring overall stakeholder relationships and ensuring stakeholders’ appropriate engagement in the project by adjusting plans and strategies as required. As the project progresses and its environment changes, this process will maintain or increase the efficiency and effectiveness of stakeholder engagement activities.

Components of the PMP such as the human resource management plan, staffing management plan, communications management plan, change management plan, and others are used in controlling stakeholder engagement.

An issue is an obstacle that threatens project progress and can block the team from achieving its goals. An issue log is a written log document to record issues that require a solution. A modified issue log is developed as a result of identifying new issues and resolving current issues.

Work performance data

Work performance data such as resource utilization, deliverables status, schedule progress, percentage of work completed, number of defects, number of change requests, technical performance measures, costs incurred, quality updates, and other factors are used in this process.

Project documents

Project documents such as issue logs, the stakeholder register, the project schedule, the change log, and others are used in this process.

Information management systems

An information management system is an automated system that can serve as a repository for information, a tool to assist with communication, and a system for tracking documents and deliverables. An information management system also supports the project from beginning to end by collecting and distributing information about cost, schedule, and performance for the stakeholders. Several reporting techniques such as spreadsheet analysis, table reporting, presentations, graphics for visual representations, and others may be consolidated from various systems and communicated to the stakeholders.

Judgment and expert opinions can be gathered from senior management, project team members, identified stakeholders, project managers from similar projects, subject matter experts, industry groups and consultants, other units within the organization, and other people to identify new stakeholders, reassess the current stakeholders, and figure out the level of involvement required from each stakeholder at various stages of the project.

Status review meetings with the team, sponsor, and other stakeholders will be beneficial for reviewing information about stakeholder engagement.

Work performance information

Work performance information such as deliverables status, change request implementation status, and forecasted estimates to completion are distributed through communication processes.

These are recommended corrective actions for bringing the imminent performance of the project as per the expectations in the PMP and recommended preventive actions for reducing the probability, and impact of future negative project performance will generate a lot of change requests.

Most of the components of the PMP may be updated to reflect changes in the stakeholder management strategy and the approach to effectively control stakeholder engagement in the project.

Project documents such as the issue log, the stakeholder register, and others may be updated.

Lessons learned from managing stakeholders, feedback from stakeholders, project records, causes of issues, reasons for corrective actions chosen, project reports, stakeholder notifications, and other items may be updated.

While the burden of disease is growing rampantly and disproportionately, the challenge to global health outreach efforts is to prioritize those illnesses, which require immediate attention. The global health equity sorts to prioritize on improving health care and achieving equity in health of people around the world. In this context, researchers from high income countries often study the existing diseases and/or emerging challenges in low income countries in order to gain expertise on the health care needs ( 20 ). In this regard, it is essential for overall program effectiveness that representatives of local communities, the stakeholders who will be most impacted by health outreach programs, be invited to provide their insights into which health needs are greatest. The encouragement of ShE and ShM often has a secondary benefit inasmuch as organization’s reputation is subsequently enhanced, which further facilitates organizational effectiveness. The very presence of stakeholders may foster an organizational environment, which encourages relevancy of program objectives to stakeholders’ expectations, a coupling, which in turn contributes to achievement of the project’s goals. Additionally, stakeholders can provide reality checks, which aid in the prioritizing of research objectives, in identifying potentially difficult political issues, and in providing the means to navigate around or to overcome challenges. The experience of stakeholders is thus invaluable for guiding research and achieving program objectives from their early stages in the laboratory to their final clinical application.

Although the process of partnering with stakeholders in clinical research settings is still in its nascent stages, it is anticipated that it will increasingly become accepted and implemented by project managers. In tandem with this process, greater efficiency and transparency will develop in working with stakeholders to meet targets ( 21 ). Part of the function of stakeholder analysis is to promote an understanding of stakeholders and to ensure that their expectations are being met. It is anticipated that project heads will increasingly encourage an awareness (ensuring transparency) of who will be affected by the project and who can contribute to making the project more successful.

Stakeholders have unique perspectives and often possess a number of capabilities which they have acquired from life experience. Program developers can derive the maximum benefit from stakeholders if the proper context is established for drawing out this experience. Alternatively, barriers to effective participation by stakeholders can occur if managers remain unaware of stakeholders’ skills, or if they believe that they do not have appropriate knowledge to contribute.

By increasing the acceptability of programs, stakeholders increase the likelihood of their success. Stakeholders play pivotal roles as healthcare advocates or healthcare ambassadors, partners, and/or agents of change. Although stakeholders differ considerably in their expertise and interests, their involvement is pivotal inasmuch as it can facilitate the successful completion of projects. Stakeholder participation can (a) improve relevance; (b) promote visibility and research transparency; (c) accelerate and translate the research findings to real-world challenges; (d) enhance greater project acceptance as confidence derived in the decisions made during the project’s milestone developments. Similarly, the project’s final outcome can only be considered successful when it is acknowledged by its key stakeholders.

Due to the broad range of ways in which stakeholders can influence program development, it is essential that their behavior be closely monitored, and modulated if necessary. One of the advantages of the described system of viewing the management of stakeholder engagement is that it documents many processes that have taken place. Future efforts to manage this type of engagement can therefore benefit from established experience.

In a nutshell, as Wheeler et al. ( 22 ) pointed out, “a truly stakeholder-responsive approach demands the acceptance of multiple stakeholders and requires that an organization develop a tolerance for ambiguity together with the sensitivities and capabilities needed to inspire trust with diverse and sometimes completing interests.”

A balanced assessment recognizes that certain caveats apply in the establishment of stakeholder engagement and management in clinical and research settings. These relate to the unique nature, demands, resources, and implementation issues which every organization has and how these demands can interact with the unique skills and abilities which stakeholders bring to it.

Many investigators lack clear or a basic understanding and/or training concerning the stakeholder framework as well as terminologies (Figure ​ (Figure2 2 ).

Project stakeholder management summary .

Often a reactive approach is favored over a proactive one for dealing with stakeholder issues is favored over a proactive one. As suggested by Greenwood, the “glorified depiction of stakeholder engagement gives way to the murky reality that engagement of stakeholders can mean many things to many people” ( 23 ). In this conceptualization, stakeholders may be viewed merely as actors with whom project managers form arms-length transactions rather making a tightly knitted partnership. This limited perspective may result in a failure to assess, understand the social, spiritual, and environmental needs of stakeholders.

Not every project can require or afford to have a full ShE or ShM system in place as outlined in this review. The main barrier here is that stakeholder involvement, and the fostering of attitudes that encourage this process, require a degree of organizational change (i.e., additional paperwork, more meetings, and more communication), which can be expensive. Hence, the benefits of managing a full program of stakeholder engagement, analysis, and management are only applicable to high impact projects. As Cennamo et al. ( 24 ) have noted a stakeholder-committed organization may still act out of self-interest. Thus, while localized programs may recognize and incorporate contributions from stakeholders and the larger community, these activities may continue to serve institutional objectives, which are narrowly focused or even possibly inimical to broader community interests. Additionally, stakeholder preferences are not absolute, but relative, and may also be evolving. Hence, the salience might change frequently across time. Another issue is that there is no generic “one size fits all” strategy for ShM and ShE, rather, the strategy and its execution depend very much on the local stakeholder landscape, as well as the problems that are being addressed. These include the stakeholder assets that are available and the opportunities that exist for their cultivation. Additionally, a barrier to effective participation and the subsequent consensus-building process is that the identified stakeholders may lack appropriate knowledge or skill sets, or believe, correctly or incorrectly, that they do not have appropriate knowledge to contribute and/or the investigators have the knowledge and experience to identify it. Stakeholders might have multiple perspectives and conflicting views, needs, and priorities. These may eventually result in identifying what they perceive to be the “best” or “appropriate” solution in any given situation, although the course of action might completely differ from that of investigators. This, in turn, results in potential “conflicts” and “trade-offs” in terms of project objectives. For example, the conflicting interest among the stakeholders with varied levels of power, importance, interest, and agenda must be managed efficiently. This poses a challenge to novice project managers to experienced investigators. These may potentially limit control mechanisms, and thus impede organizational performance. On the contrary, it is difficult to generate interest and involvement in projects, which are perceived to have little or immediate relevance. Finally and most importantly, while most of the ShE literature emphasizes the positive benefits of stakeholder engagement, it less frequently addresses the potential costs and risks with the adoption of a stakeholder perspective.

Above all, it is impossible to engage with stakeholders and to do stakeholder management in an authentic and effective way without dealing with the multiplicity of ethical issues that arise. These issues arise, first of all, because the stakeholders’ interests can conflict along key ethical dimensions. Therefore, engaging with them must be sensitive to the rights of the parties involved, as well as to the overall harms and benefits, which accrue from managerial action. Second, it is not always apparent when there may be conflicts of interests or hidden advantages or hidden disadvantages among key stakeholders and decision makers. Obviously, these conflicts must be disclosed, and many organizations have specific procedures for handling such conflicts. However, given the nature of the decisions that are to be made, managers must be willing to accept that effective stakeholder management places them squarely in the realm of ethical decision making.

It is not always possible to anticipate all of the ethical issues and conflicts, which may develop in such a multi-stakeholder environment. Therefore, the traditional method of assigning responsibility for solving these problems to an ethics committee does not always work. Clinical project managers must be willing to make choices based on both good ethics (based on PMI’s code of ethics and professional conduct) and on the overall purpose and values of their institution that is best for all stakeholders ( 27 ). While some ethical issues can be anticipated at the start of the project, all should be subjected to discussion among the project stakeholders to find the best possible course of action.

Assuming that the challenges reviewed above can be overcome, additional “higher order” issues will emerge. These will consist of how to best promote the operational adaptability, viability, and implementation of the changes in an acceptable timeframe. Project managers will need to ask if the benefits of managing a full stakeholder analysis are really greater than the costs associated with it. Efforts will also need to be directed toward retrospective analysis, i.e., did real cases go badly because the stakeholder views were not sought out? The difficulty of these questions varies in different clinical settings but it is essential that they be resolved for maximum project effectiveness.

In summary, the concept of promoting stakeholder engagement and management is a relatively recent one in the clinical research arena; hence, there are many lessons to be learnt in the coming years. As this is an iterative process, although the current efforts from funding agencies such as PCORI are necessary but are insufficient to respond to the above challenges. All indications are that attempts to meet these challenges will nevertheless provide significant benefits for project management effectiveness.

From a clinical standpoint, stakeholder engagement and management is pivotal to the development and deployment of community-oriented national and global health initiatives. The ultimate purpose of such engagement is the efficient use of time, money, and resources thereby positively impact existing and/or emerging healthcare challenges.

For the purpose of our review, we have followed the guidelines of PMBOK ® ( 7 ), which provides a common vocabulary to guide the processes. In doing so, our review outlines a systematic model for planning, managing, and implementing stakeholder engagement based on PMBOK ® guidelines. Further, the application of the project management knowledge, skills, tools, and techniques can augment the chances of success, even in complex projects.

This review has drawn on the experience of stakeholder engagement in private organizations and government agencies and has argued that the process is equally viable in hospital program development and in clinical research. It has taken the view that the concept of stakeholder engagement and a proper stakeholder management framework is more than a useful adjunct to pursuing project or program goals and is actually pivotal for enhancing organizational success.

These guidelines have been broken down into a number of component parts. It emphasizes that the stakeholders should first be identified, that their interests and expectations should be understood, and that their level of power and influence should be understood as well. A plan for communicating with stakeholders has been outlined and techniques for encouraging their participation and management have been laid out.

Author Contributions

All authors intellectually contributed to the design, analysis, and interpretation of the results and to drafting the critical review of manuscript. All authors reviewed and approved the final version of the manuscript.

Conflict of Interest Statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Acknowledgments

The authors would like to sincerely thank Professor Philip Kotler, S. C. Johnson & Son Distinguished Professor of International Marketing, Kellogg School of Management, Northwestern University, USA for his time, advice, and his valuable comments on the earlier versions of our manuscript, which enormously improved the quality of the final manuscript. We are also grateful for the comments from the anonymous reviewers. We gratefully acknowledge the National Institutes of Health; National Institute of Mental Health; Duke Endowment; South Carolina Department of Health and Human Services. As of the end of 2012, the Duke Endowment had provided more than $7.25 million in support of the program. Additional funding has come from the South Carolina Department of Health and Human Services, the National Institute of Mental Health (NIMH), and the National Institutes of Health (NIH). NIMH and NIH awarded two grants (one in 2009 and one in 2012) totaling $3.04 million to support evaluation of project outcomes (on quality, economic impact, utilization, and sustainability). In addition to grant funding, user fees and third-party insurance cover some program-related costs; for example, beginning in 2013, BlueCross BlueShield of South Carolina began covering use of telemedicine in mental health. However, the funders had no involvement in study design, data collection, data analysis and interpretation, preparation of the manuscript, or in the decision to submit the manuscript for publication.

Appendix: Examples of Stakeholder Engagement

Statewide telepsychiatry initiative.

In one of our landmark study by the author (MN), the South Carolina Department of Mental Health partnered with the University of South Carolina School of Medicine, Department of Health and Human Services and 18 predominantly rural hospitals from the South Carolina Hospital Association to establish the statewide telepsychiatry initiative. In this public-private-academic partnership, the psychiatrists were available via teleconference 16 h a day, 7 days a week, to assess and treat patients with mental health issues at hospital emergency departments.

The clinicians called the psychiatrist on duty whenever they have a patient who needed a mental health assessment and/or counseling and provide relevant medical records and details. Through a secure video link, the psychiatrists were able to assess the patient and makes recommendations about needed treatment and follow-up, including referrals to community-based resources.

The advantage of such program was that, it drastically reduced emergency department wait times, inpatient admissions, as well as costs; increased attendance at follow-up outpatient appointments; and generated higher level of satisfaction among patients and clinicians. Additional evidence includes post-implementation surveys that gauge the satisfaction of patients and clinicians with the program.

In such an innovative approach, the stakeholder (State Department of Mental Health, University of South Carolina, Department of Neuropsychiatry and Behavioral Science, Hospital, Physicians and Nurses from the South Carolina Hospital Association, and Patients) engagement proved to be feasible, necessary, and beneficial in clinical environment.

Outcome of the initiatives – did it work?

The program has reduced emergency department (ED) wait times, inpatient admissions, and costs; increased attendance at follow-up outpatient appointments; and generated high levels of satisfaction among patients and clinicians.

Shorter ED Wait Times: From March 2009 through 2014, the average waiting time for patients with mental health problems at the 18 participating EDs fell by roughly 50%. Fewer hospitalizations: during the same timeframe, 11% of ED patients assessed by a psychiatrist were hospitalized, half of the 22% admission rate among similarly cared-for patients in South Carolina EDs not offering this program.

Health care utilization: Telepsychiatry consultations resulted in an estimated $1,400 less per mental health patient compared to patients seen in ED’s that did not have telepsychiatry due primarily to the reductions in hospital admissions.

Greater attendance at follow-up appointments: About 46% of patients served by the program attended an outpatient follow-up appointment within 30ădays of the initial ED visit, well above the 16% attendance rate among similar ED patients cared for in South Carolina hospitals not offering the program. Similarly, 54% of patients served by the program attended a follow-up appointment within 90ădays versus 20% among ED patients in hospitals not offering the program.

High satisfaction among patients and staff: More than 80% of patients served by the program reported being satisfied with the process and services received. In addition, 84% of ED physicians and staff believe that the program has improved patient care; 91% report being satisfied with program-related procedures; and 84% express satisfaction with the technology used.

How we did it: Planning and development process key steps included the following:

Decision to focus on telepsychiatry : The increasing popularity of telemedicine and its potential to bring services to underserved geographic areas made telepsychiatry a logical initial target for these discussions. After reviewing the use of telemedicine in South Carolina and other States, the partners collectively decided to create and implement a telepsychiatry program in hospital EDs.

Securing of funding for demonstration project : In 2007, program leaders contacted the Duke Endowment (a non-profit foundation that supports innovative health care programs) for funding a demonstration project. In 2008, the Duke Endowment agreed to provide a $3.7 million, 3-year grant for this purpose.

Project planning : Four hospitals agreed to participate in the demonstration project, which launched in March 2009. In advance of this date, the partners and participating hospitals worked together to hire and train six psychiatrists, install and test the video equipment in EDs, and set up an EMR system linking the psychiatrists with the EDs.

Program expansion : After the demonstration project went smoothly, program leaders decided in June 2009 to expand the program to three additional sites and have continued to add more sites gradually since that time. From March 2009 through August 2014, more than 20,000 telepsychiatry ED consults have taken place. As of August 2014, 20 hospitals participate, with plans to add 6 more in 2014.

Standardization of training : As the initiative expanded, program leaders standardized the training process for psychiatrists and ED staff, as outlined below:

Psychiatrist training : Participating psychiatrists complete 6ăh of clinical training by viewing videos prepared by University of South Carolina School of Medicine faculty. Supplemented with handouts, the videos cover child and adolescent psychiatry, adult psychiatry, geriatric psychiatry, addiction psychiatry, risk assessment, and legal issues. Newly hired psychiatrists also undergo peer review every 2ăweeks during their first 3ămonths of employment. In addition, during this initial 3-month period, the supervising psychiatrist meets with other hospital physicians to review and discuss consultations performed by newly hired psychiatrists.

ED staff training : ED staffs in participating hospitals watch a video that explains the videoconferencing system and reviews the goals of the program and the training and credentials of the participating psychiatrists. A member of the project leadership team visits each participating ED to discuss questions or concerns that staff might have about the program.

Ongoing meetings to resolve problems, plan expansion : Representatives of the partnering organizations and the participating hospitals meet on a quarterly basis to share program-related experiences, resolve any issues or problems that arise, and discuss and plan for expansion to other EDs. Typically, hospital administrators, providers, researchers, and information technology staff come to these meetings; representatives of non-participating hospitals are also welcome to attend to learn more about the program.

Resources used and skills needed

Staffing : Six full-time psychiatrists and one part-time psychiatrist staff the program, under the supervision of a lead psychiatrist. The program includes several stakeholders namely a director, coordinator, fiscal technician, programmer, and two information resource consultants (subject matter experts; SMEs). Faculty and staff members from the University of South Carolina and Emory University, staff members from the Department of Mental Health and from the South Carolina Office of Research and Statistics also provide support to the program.

Costs : Hard data on the program’s total annual cost are not available. Major program expenses consist of staff salaries and the upfront and ongoing expenses associated with the videoconferencing and EMR technologies.

Using project management principles to improve research projects

Science Photo Library / Alamy Stock Photo

After reading this article, you should be able to:

• Understand the principles of project management and how they can be applied to clinical trials;
• Identify some of the tools that can be used for research project management;
• Understand the role of the pharmacist in these processes .

Introduction

Research is an integral component of any modern healthcare service that incorporates evidence-based practice, where clinical decisions are made based on available research to ensure balanced and appropriate clinical guidance ​[1]​ . The current high standards of medical care are partly attributable to the clinical studies that have been conducted under the guidance and funding of regulatory bodies, such as the National Institute for Health and Care Research (NIHR) and the UK Medical Research Council. In addition to testing new drugs and devices, clinical trials provide a scientific basis for advising and treating patients, contributing immensely to safe and effective clinical practice.

Pharmacists play a vital role in the clinical trial process. They are often responsible for dispensing medications and ensuring that the study protocol is followed correctly. Additionally, pharmacists can provide valuable input in the design of clinical trials, particularly in areas related to medication dosing and drug interactions ​[2]​ . They can also assist with data collection and analysis, which is essential for evaluating the safety and efficacy of new medications.

Applying project management principles to clinical research has the potential to improve efficiency across the research process. This article will outline the five basic phases of project management and show how they can be beneficial to research projects. It will also highlight the role of the pharmacist in clinical research and show how common obstacles to project management approaches can be overcome.

Managing clinical trials

A successful clinical trial requires organisation and the effective execution of activities and tasks, within given timelines and in a step-wise manner, and must be managed meticulously to avoid unnecessary delays and problems. It can be a time-consuming, difficult and challenging task that must be fulfilled with a finite budget, and therefore requires careful planning and organisation from the onset. An analysis of 114 multi-centre clinical trials showed that 45% of trials failed to reach 80% of the pre-specified sample size required to obtain significant data, and around a third were unable to recruit study participants within the time specified and had to extend, costing more time and resources ​[3]​ .

Box 1: Clinical trial phases

Clinical trials are divided into four phases, each with its own purpose and design.

Phase 1: Trials are the first step in testing a new drug or treatment in humans. They are conducted to evaluate the safety of the drug and determine the appropriate dosage. Typically, phase 1 trials involve a small group of healthy volunteers, who are closely monitored for adverse effects. Phase 1 trials can last several months, and the results are used to inform the design of subsequent trials.

Phase 2 : Trials are conducted to evaluate the safety and efficacy of the drug or treatment in a larger group of patients. These trials can last several years and involve hundreds of participants. Phase 2 trials also determine the optimal dosage and any potential side effects.

Phase 3 : These trials are the largest and most expensive phase of clinical trials. They are designed to confirm the safety and efficacy of the drug or treatment in a large, diverse population. Phase 3 trials can involve thousands of participants and can last several years. The results of phase 3 trials are used to support an application for approval by regulatory authorities, such as the US Food and Drug Administration.

Phase 4 : Trials are conducted after a drug or treatment has been approved by regulatory authorities and is on the market. These trials are designed to monitor the long-term safety and efficacy of the drug or treatment in a larger, more diverse population. Phase 4 trials can also be used to explore new uses for the drug or treatment, or to compare it to other treatments ​[4]​ .

Applying project management principles to clinical trials

We propose that clinical trials can be conducted more efficiently using project management principles. A project is any temporary endeavour that has a clear beginning and end, clear boundaries and is creating something new that did not previously exist. Large and small clinical trials can be classified as ‘projects’.

Project management can be described as having five steps:

• Controlling and monitoring
• Closing ​[5,6]​

These principles were initially developed for engineering and construction-based disciplines, but can easily be applied to academic research projects, pharmaceutical industry work[8] and, in particular, prospective studies, such as clinical trials ​[7]​ . By systematically applying the above project management principles, it is possible to eliminate costly mistakes, prevent budget overruns, improve quality and save time ​[8,9]​ .

There are very few clinical trials that have applied the principles of project management to guide and implement the full process from inception to completion. The Obsessive Compulsive Treatment Efficacy Trial (OCTET), funded by the NIHR, is one of the few studies to also investigate the application of research project management tools to the management of the trial. The purpose of this part of the study was to evaluate whether adoption of the main principles of project management would lead to successful completion and greater satisfaction for the staff involved in the day-to-day operation of the trial. It was concluded that developing trial management and methods was vital to the success of clinical trials ​[10]​ . Another example of the successful application of project management principles to a clinical study is the Alcohol and Pregnancy Project ​[11]​ . As part of this, the researchers comprehensively endorsed project management and agreed that it contributed substantially to the research outcome ​[11]​ .

In this article, the main principles of project management will be applied to research projects in health settings, using a clinical trial as an example of a complex project in a multi-centre setting.

Step 1: Initiation

The study proposal is the formal initiation of a clinical trial project. It gives the background for the research project and describes the transformation of the research question/hypothesis into an actual study.

The study proposal should include the following elements:

• What the trial is trying to achieve (i.e. objectives, the study intervention and the differences in treatment sought);
• Sample population;
• Eligibility criteria;
• Study intervention;
• Sample size;
• Differences in the treatment effects that are sought;
• How data will be collected;
• Data collection and analysis according to Good Clinical Practice guidelines;
• How the project will be monitored and controlled to ensure it is delivered on time;
• How the trial results will be reported and disseminated;
• Quality assurance to ensure reliable and reproducible results of the highest standards ​[6,12,13]​ .

Ethical approval must be sought at this stage and a steering committee set up, chaired by the principal investigator and others who will provide guidance and advice, but not be involved in the implementing of the project on a practical level. Finally, applications must be submitted to a funding organisation, which will give the green light for the next phase of the project.

Step 2: Planning

Formulate a clear project protocol that involves every aspect of the vision and scope of the project, including the day-to-day running of the trial. This is the most important phase of the project, as it allows the researchers and investigators to devise a clear plan on how to manage the process according to the scope of the study, within a designated timeframe and within budget. The major features of this phase of project management are:

• Study protocol;
• Study budget;
• Study manuals, documentation and software.

Study protocol

The study protocol is the plan of how the overall study will be managed by estimating a realistic time schedule of what can be achieved. It allows the investigators and all individuals involved to keep the project on time and within budget. The main features are:

• The timings for grant submission and grant approval;
• Site activation;
• Study participant recruitment;
• Data collection and data analysis;
• Outlining the timing and sequence of each major event within the study;
• The sequence of events required to meet the study objectives;
• Defining the persons responsible for activities and tasks;
• Establishing methods of communication between the steering committee and the independent data safety and monitoring committee.

Study budget

The main features of budgeting and costs for projects are:

• Estimating the budget and cost for each major milestone within the project lifecycle;
• Itemised budget for staff salaries (e.g. researchers, investigators, database programmers, statisticians);
• Site payment for contributing hospitals and study intervention costs;
• Contingency funds if events do not follow the protocol.

Study manuals, documentation and software

Study manuals ensure all staff receive the same training and make it more likely that staff will conduct the study in the same way — this is particularly relevant for clinical trials involving several sites (multi-centre trials). If drugs are being investigated in the study, a pharmacy manual is essential to specify preparation, storage, routes of delivery to the body and destruction. Finally, randomisation of study participants to different treatment arms in a confidential manner requires the use of software systems, which must be acquired and established.

Documentation relating to all aspects of the clinical trial is essential and should be recorded, monitored and archived in accordance with Good Clinical Practice (GCP) guidelines ​[13,14]​ . GCP is a quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the clinical trial data are credible. Source documentation includes the clinical history and medical records of all study participants before, during, and after the trial ends, records relating to staff training, handling of all drugs used, standard operating procedures, laboratory reports etc. This will ensure safety of study participants, accountability, and high-quality results. An audit in 2010 by the US Food and Drug Administration found that 6 out of 10 clinical trials did not keep adequate documentation ​[14]​ .

Step 3: Execution

At the execution stage of a project, the study plan is implemented and the clinical trial commences. The main features of this phase are:

• Teams are acquired and developed;
• Allocation of resources and support is provided to team members to ensure that assigned tasks are completed;
• Quality assurance is performed (see Step 4);
• Deliverables are developed and completed to meet the project’s aims and objectives;
• Communication links are established with the clinical teams and stakeholders (e.g. pharmaceutical companies, funders, regulatory agencies, study participants, research institutions);
• Research is conducted (e.g. analysing samples, synthesising and analysing data);
• Educational resources are disseminated to healthcare professionals, stakeholders and the general public ​[9,15,16]​ .

Step 4: Controlling and monitoring

This process occurs alongside the execution phase, focusing on measuring project progression and performance in line with previously agreed goals and timelines. The project plan specifies the quality assurance, control, monitoring and risk assessment of activities conducted while the clinical study is in progress. This includes, but is not limited to:

• Onsite monitoring and audits (e.g. looking through medical records and cross-checking data against case report forms);
• Reviewing the study manuals and files to ensure essential documents are up to date;
• Reviewing all manuals, including staff training manuals and standard operating procedures;
• Making sure research is conducted in accordance with GCP and Medicines and Healthcare products Regulatory Agency for research with human participants;
• Regularly reviewing the tasks and activities associated with each milestone;
• Data management (e.g. data checking, ensuring the data is void of errors);
• Interim data analysis;
• Safety monitoring ​[13,17]​ .

The outcomes of control and monitoring are compared to the original study plan and adjustments can be made if necessary.

A good clinical trial will have a contingency plan in place that was developed before the execution phase. It will specify the possible risks, the likelihood of them occurring, the potential impact on the project and the course of action recommended should they occur.

Step 5: Closing

Towards the end of a research project, the main activities involve:

• Final analysis of the data;
• Reporting of the data (e.g. presentations or a manuscript in a peer-reviewed journal);
• Closing of study sites;
• Informing ethics committee and trial staff of completion;
• Submitting final reports to funding bodies;
• Informing study participants of the completion of the clinical trial and the outcomes;
• Archiving records in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s good clinical practice guidelines, which state that all documentation should be kept for at least three years after completion of the clinical trial ​[13]​ .

In addition, a post-trial review might be conducted, in which management of the clinical trial is evaluated to determine strengths and weaknesses in the process, so that future clinical trials can be conducted more effectively ​[16]​ .

Role of the pharmacist in clinical trials

Pharmacists play a crucial role in clinical trial management, particularly in the areas of drug preparation, dispensing and management of adverse drug reactions. They are responsible for ensuring that the investigational drug is properly handled and administered to trial participants, and that any adverse events or drug interactions are documented and reported appropriately.

According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, pharmacists’ expertise is useful in the planning and conduct of clinical trials, particularly in the following areas:

• Investigational medicinal product management: preparation, labelling, storage, temperature monitoring, dispensing and accountability. This includes ensuring that the drug is handled and stored in accordance with the trial protocol and applicable regulations;
• Drug safety: monitoring trial participants for any adverse drug reactions or interactions and reporting these events to the study team and regulatory authorities;
• Compliance monitoring: pharmacists can help ensure that trial participants comply with the dosing regimen and other requirements of the trial protocol, and provide education and counselling as needed to ensure proper adherence;
• Quality control: general check of documentation, including informed consent forms and other legal documents;
• Data management: pharmacists are responsible for maintaining accurate records of drug dispensing and adverse event reporting, and for ensuring that these records are kept confidential and secure.

The success and failure of clinical trials

There are many challenges associated with managing clinical research projects. One of the main problems encountered in clinical trials, which has been cited repeatedly, is the difficulty of registering a sufficient sample size of patients in a timely fashion ​[18,19]​ . Trials that did manage to recruit successfully were more likely to have a dedicated trial manager ​[20]​ . Another challenge in multi-centre studies is identifying appropriate clinical sites and having realistic recruitment expectations. However, the main challenge is implementing and maintaining effective management systems and techniques in response to the needs of the project.

Box 2: Top tips to overcome the challenges of project management

• Define project scope: clearly define the scope of your project, including the goals, objectives and deliverables;
• Develop a project timeline: create a detailed project timeline that outlines milestones and deadlines for your project;
• Communicate regularly: establish regular communication channels with all stakeholders involved in the project, including team members, sponsors and other relevant parties;
• Monitor project risks: identify potential risks to the project and develop contingency plans to address them;
• Use project management tools: consider using tools such as Gantt charts, project management software and risk management tools.

Project management in health and medical research can substantially benefit both the managerial and scientific as­pects of clinical trial projects. Project management may also reduce a proportion of fund waste ​[21]​ . Staff that were part of the Alcohol and Pregnancy Project found that project management strategies improved communication and the integration of project work across multiple organisations and professions; helped them clarify and agree goals; assisted the delivery of defined project outcomes; and helped ensure accountability for results and performance[10]. Although this article has focused on the application of project management principles to clinical trials, these principles can be applied to any pharmacy project, whether research-related or not; for instance, clinical audits and quality improvement initiatives.

By using project management principles, pharmacists can ensure that their projects are completed on time, within budget and to the desired quality standards. In addition, using these principles allows pharmacists to enhance the quality and impact of their own projects, ultimately improving patient care and healthcare outcomes.

• 1 Kristensen N, Nymann C, Konradsen H. Implementing research results in clinical practice- the experiences of healthcare professionals. BMC Health Serv Res. 2015; 16 . doi: 10.1186/s12913-016-1292-y
• 2 Brown J, Britnell S, Stivers A, et al. Medication Safety in Clinical Trials: Role of the Pharmacist in Optimizing Practice, Collaboration, and Education to Reduce Errors. Yale J Biol Med 2017; 90 :125–33. https://www.ncbi.nlm.nih.gov/pubmed/28356900
• 3 Francis D, Roberts I, Elbourne DR, et al. Marketing and clinical trials: a case study. Trials. 2007; 8 . doi: 10.1186/1745-6215-8-37
• 4 Evans SR. Fundamentals of clinical trial design. Journal of Experimental Stroke and Translational Medicine. 2010; 3 :19–27. doi: 10.6030/1939-067x-3.1.19
• 5 Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010; 11 . doi: 10.1186/1745-6215-11-78
• 6 A Guide to the Project Management Body of Knowledge . 7th ed. Project Management Institute 2021.
• 7 Notargiacomo Mustaro P, Rossi R. Project Management Principles Applied in Academic Research Projects. IISIT. 2013; 10 :325–40. doi: 10.28945/1814
• 8 Overgaard PM. Get the keys to successful project management. Nursing Management. 2010; 41 :53–4. doi: 10.1097/01.numa.0000381744.25529.e8
• 9 Payne JM, France KE, Henley N, et al. Researchers’ experience with project management in health and medical research: Results from a post-project review. BMC Public Health. 2011; 11 . doi: 10.1186/1471-2458-11-424
• 10 Arundel C, Gellatly J. Learning from OCTET – exploring the acceptability of clinical trials management methods. Trials. 2018; 19 . doi: 10.1186/s13063-018-2765-6
• 11 Huljenic D, Desic S, Matijasevic M. Project management in research projects. Proceedings of the 8th International Conference on Telecommunications, 2005. ConTEL 2005. 2005. doi: 10.1109/contel.2005.185981
• 12 The Guide to Efficient Trial Management. UK Trial Managers’ Network. 2020. https://www.tmn.ac.uk/resources/34-the-guide-to-efficient-trial-management (accessed Apr 2023).
• 13 E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). US Food and Drug Administration. 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1 (accessed Apr 2023).
• 14 Bargaje C. Good documentation practice in clinical research. Perspect Clin Res. 2011; 2 :59. doi: 10.4103/2229-3485.80368
• 15 Clinical Trial Protocol Execution within a Clinical Research Organisation. BioPharma Services. 2021. https://www.biopharmaservices.com/blog/clinical-trial-protocol-execution-within-a-clinical-research-organization-cro/ (accessed Apr 2023).
• 16 McCaskell DS, Molloy AJ, Childerhose L, et al. Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. Trials. 2019; 20 . doi: 10.1186/s13063-019-3634-7
• 17 Good clinical practice for clinical trials. Medicines and Healthcare products Regulatory Agency. 2023. https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials (accessed Apr 2023).
• 18 Goodarzynejad H, Babamahmoodi A. Project Management of Randomized Clinical Trials: A Narrative Review. Iran Red Crescent Med J. 2015; 17 . doi: 10.5812/ircmj.11602
• 19 Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemporary Clinical Trials Communications. 2018; 11 :156–64. doi: 10.1016/j.conctc.2018.08.001
• 20 Campbell M, Snowdon C, Francis D, et al. Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study. Health Technol Assess. 2007; 11 . doi: 10.3310/hta11480
• 21 Carroll C, Patterson M, Wood S, et al. A conceptual framework for implementation fidelity. Implementation Sci. 2007; 2 . doi: 10.1186/1748-5908-2-40

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CT: Project Management in Clinical Trials

It has become increasingly more important to use solid project management principles when managing clinical trials. This course teaches the basic skills of project management derived from PMI principles but with focus on clinical trials. Plenty of situational examples will be provided in order to maximize understanding and clarity. Topics include a brief history of the Project Management Institute (PMI), key terms and definitions, detailed review of  process groups, knowledge areas and their linkage to project management process groups, multiple tools and templates that can be utilized across the knowledge areas, virtual project management, review of personality types using the DiSC model and how that knowledge can be effectively used to manage a team, as well as program, portfolio and alliance management.  

Other Credits:  BRN 30 CE hours

Course Number:  FPM-40656 Credit:  3.00 unit(s) Related Certificate Programs:   Clinical Trials Design and Management

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Online Asynchronous. This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required. You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

Sivaramakrishna, Radhika

Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP has over 25 years of experience having served in roles of increasing responsibility on all sides of the business (academic site, sponsor, CRO, 3rd party vendor) in project management, clinical operations, operational excellence, outsourcing and other related areas. She has significant experience in multiple therapeutic areas including oncology, immunology and rare diseases. She is PMP-certified, is an ASQ-certified black belt as well as has a CCRP certification through SOCRA.   Currently she is Senior VP, Clinical Operations and Compliance at Quantum Leap Healthcare Collaborative, a non-profit organization partnering with multiple drug manufacturers and academic sites to run large platform studies studying new therapies f... Read More

No textbook required.

Refund deadline: one week after enrollment or start date of section, whichever is later.

DATE & LOCATION:

3/25/2024 - 6/14/2024 extensioncanvas.ucsd.edu You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

6/24/2024 - 9/14/2024 extensioncanvas.ucsd.edu You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

There are no sections of this course currently scheduled. Please contact the Healthcare & Behavioral Sciences department at 858-534-9262 or [email protected] for information about when this course will be offered again.

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Project Management Best Practices™

For employers looking to expand project management skills across the entire study team, this training program delivers practical, hands-on training specific to clinical research..

This is an intensive two-day course which provides detailed and practical guidance on the different project management skills used by study sponsors and Contract Research Organizations (CROs), so helps you decide how to apply these skills in your situation. The course is specifically designed for clinical research project management, with examples and exercises developed using pharmaceutical research scenarios. A key component of this course is that you will learn how to take control of your clinical trials, to manage and direct them, rather than simply tracking what is happening.

Attendees new to project management will receive an introduction to the project management of clinical trials, whereas those more familiar with project management will receive a boost to their knowledge and further their understanding of how sponsor and CRO companies operate.

Learning Objectives

• Define project management and understand the differences between the role of project management and a senior clinical role.
• Apply measurement and control to project timelines, tasks and staff resourcing.
• Describe different management methods and how they operate to achieve project control.
• Cite aspects of project management from budget management to operational delivery.
• Properly document your project management systems and procedures.

Clinical research professionals interested in enhancing project management skills or moving into a project management role.

Clinical Project Manager

Clinical trial management certification.

Demo Clinical Project Manager Training

Research Project Manager Certification

CCRPS Research Manager Graduates obtained job roles including:

Clinical Trial Project Manager, Research Nurse Manager, Clinical Research Coordinator-Data Manager, Clinical Research Associate, Transdisciplinary Research Project Manager, IT Project Manager in Clinical Research, Publicly Funded Research Project Manager (2024 CCRPS Graduate LinkedIn Survey).

Clinical Research Project Manager Training

Advanced Clinical Research Associate Certification (ACRAC)

Introduction

CME Handout

Common Terminology Used In Clinical Research - Reference Glossary

Commonly Used Abbreviations and Terms in Clinical Research

An Overview of ICH GCP

CFR 21 Part 11

Ethics of Research Involving Children

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Pregnant Women and Fetuses

Fundamentals of Project Management

Project Management Fundamentals

PMBOK Summary - Mandatory Project Management Review

Clinical Trial Project Management

Importance of Project Management

Roles and Relationships in Clinical Trials

Role of a Project Sponsor

ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

Data Safety Monitoring board- DSMB

Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

Contract Research Organizations (Delegation, Responsibilities, Management )

ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

Skills of a Project Manager

Essential skills of a Project Manager

Technical skills for Project Management

Project Team

Managing a Project Team

Project Management Documents

Regulatory Documents

Regulatory Documents in Clinical Trials

Delegation of Authority Log – DOAL

Investigators Brochure (IB)

Trial Master File

Essential Regulatory Documents Binder Tab Organization (Trial Master File)

Trial Master File Reference Guide

New Drug Application

The Investigational New Drug (IND) & New Drug Application (NDA) Process

Investigator Initiated Multi-Center Trials

IND and IDE AE Reporting

Safety Reporting Requirements for Sponsor Investigators of An IND

Problem Solving in Project Management

Problem Solving as a Project Manager

Project Failures and Statistics

Project Reporting Styles

Avoiding Project Failure

Budgeting for Clinical Trials and Projects

Project Budgeting

Payments and Budgeting for Investigators and Site

Advertisement Aid in Subject Recruitment and Retention

Clinical Trial Design

Advanced Designs of Clinical Trials

Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

Blinding and Unblinding in Clinical Trials

The Clinical Trial Protocol - Advanced Mastery Review

Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

Project Management Scheduling and Tracking

Basics of Project Scheduling

Project Progress Tracking

Project Management Planning Process

Project Management Plan

Closing a Project

Project Delays

Process Mapping

Metric Tracking

Duties of a Successful Project Manager

Roles and Responsibilties of a Project Manager

Project Management Success Factors

Adverse Events

Advanced Review of Adverse Events

Site Selection and Visits

Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

Audit and Inspections

Audits and Inspections in Clinical Trials

Clinical Trial Data Audits

FDA Warning Letter

Quality Control and Safety

Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)

ICH GCP - Safety of Human Subjects in Clinical Research

Technology in Trials (IVRS, CTMS, EDC)

Clinical Trial Management System-CTMS

ICH GCP - Trial Management, Data Handling, and Record Keeping

An Overview of Remote Monitoring - COVID-19 Update

Centralized Monitoring

Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)

Pharmacovigilance and Regulatory Affairs

Advanced Practice of Pharmacovigilance

Regulatory Affairs for Clinical Trials

Investigational Product and Labs

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)

Patient Recruitment, Retention, and Compliance

Patient Recruitment in Clinical Trials

Patient Engagement and Retention in Clinical Trials

Patient Adherence and Compliance in Clinical Trials

Project Manager Job Readiness

Project Manager Skills Interview Questions

Interview Questions

Competency Examination

Competency Exam

About this course

• Required: Prior clinical research or project management experience.
• Length: 100 hours. Online, self paced, start anytime.
• ACCRE, Joint Accreditation with AMA, ANCC, ACPE for 17.5 CME. Online certificate. Exam score 70% or higher on 2 attempts.

Enroll Schedule Advising

CCRPS Reviews

Clinical Research Project Manager Certification

Navigating the Course

Natalie johnson.

I was originally intimidated by the materials and all that I had to learn. The syllabus, the instructors and the course material were easy to follow and lear...

I was originally intimidated by the materials and all that I had to learn. The syllabus, the instructors and the course material were easy to follow and learn from. I am very happy I completed the course.

Advanced Clinical Research Project Manager Certification ...

Roger andersen.

There is extensive material in this course. It is highly relevant to managing clinical trials.

Advanced Clinical Research Project Manager

Ellen lyrtzis.

The clinical trial project manager is responsible for different aspects of the clinical trial process, such as setting timelines, developing budgets, and overseeing data analysis. To become a clinical trial manager, you can gain experience in project management or clinical research roles. Clinical trial manager certification will increase your chances of getting hired.

To become a clinical project manager, one must first obtain a Bachelor's degree in a health-related field. Additionally, developing skills for project management and participating in relevant courses are necessary.

Experience can be gained by volunteering or interning in clinical trials with pharmaceutical companies or medical research centers.

Pursuing an advanced degree or getting certified as a Clinical Project Manager with open up more opportunities.

Clinical Trial Manager

Clinical Trial Managers are responsible for planning and overseeing all aspects of clinical research projects. This includes making sure the project is conducted according to regulations and best practices. They also manage budgets, timelines, and resources to ensure the project is completed successfully.

Clinical Project Managers plan and execute clinical research projects by coordinating with internal and external stakeholders, regulatory authorities, and by develop key documents like protocols, consent forms, investigator brochures, budget sheets, study reports, and final reports.

Clinical Research Manager

Clinical Research Managers make sure that data is being collected and analyzed correctly, and that everyone is compliant. Clinical Project Managers design research studies and monitoring projects in terms of cost, budgeting, quality assurance, and risk assessment.

The Clinical Trials Management Certificate program is designed to provide students with the knowledge and skills necessary to design, implement, and manage clinical trial protocols.

This Clinical Trials Design & Management Certificate Program introduces learners to the fundamentals of clinical trials design and management.

The program covers principles and regulations of clinical trial design, analysis techniques for statistical analysis, quality control and assurance, data management and reporting.

Students will also gain an understanding of risk assessment strategies, study site selection, protocol implementation and monitoring, resource management as well as safety requirements for conducting clinical trials.

Clinical Trial Manager Salary

Clinical manager salary.

Clinical trial manager salaries vary based on experience, location, and company size. The average hourly rate for a clinical trial manager is $30-$60 per hour.

Clinical trial manager salary

The monthly salary of a clinical trial manager typically ranges from $5,000 to $10,000. Those with more experience or who work at well-known organizations can earn up to $20,000 per month.

Clinical project manager salary

Annual clinical project manager salary ranges between $60,000 and $120,000 dollars per year. The median salary for a clinical trial manager is approximately $82,500 across all industries and geographies

What does a Research Project Manager do?

Clinical Project Managers are responsible for creating project plans, timelines, budgets, and communication with vendors and stakeholders. They also provide training to personnel involved in the project, establish systems to track project progress, and identify risks associated with the project.

Clinical Project Managers make sure that clinical research projects go well by working groups like contract research organizations (CROs), internal departments, and external vendors. Clinical Project Managers make sure that projects follow the research protocols, good clinical practices (GCPs), applicable regulations, and standards.

Research Project Managers also develop protocols for data collection and analysis, prepare reports for regulatory submissions, coordinate activities related to safety monitoring, and provide support to staff during project-related training sessions or workshops.

Trial Project Managers make sure that data is collected accurately according to guidelines from the FDA or EMA. This includes finding risks associated with the project; assessing their impacts; planning ways to reduce the risks; and also planning how to use resources so that everything runs smoothly.

The most advanced clinical trial project management training available

Take the fast track.

Take the fast track to a lucrative career as a Clinical Research Project Manager to start earning salaries of $100k+

Get advanced training

Get the most advanced training - ACRPM is recognized as a gold standard by many CROs in the industry thanks to its comprehensive training

Work at your own pace

Work at your own pace from wherever you are with flexible online training. The 100+ modules included can be completed in as little as 2 weeks

Requirements

Designed for those holding a minimum of a BA in Science, ACRPM is internationally accredited to ACCRE, ACCME, ACPE, ANCC, and Transcelerate Biopharma. In other words, upon completion of the course and the final exam, you will have a level of knowledge equivalent to (and beyond!) that of a senior CRA.

ACRPM features 100+ modules, or 250 hours, of on-demand online training (worth 17.5 CME credits). The course has been put together by clinical trial project managers, enabling students to build a deep knowledge of the industry.

Certification

This course can be completed in as little as two weeks, with certification and a letter of recommendation awarded after completing a final exam. ACRPM also provides you with tools to help you find a job, including resume and interview guides, giving you a further edge over other applicants for the same position.

Clinical Project Manager Guide

Clinical Project Managers are responsible for clinical research activities and initiatives in the healthcare, pharmaceutical, and biotechnology sectors. This includes creating and implementing project plans, developing timelines, overseeing budgets, managing resources, and ensuring compliance with regulatory requirements. CPMs typically work with cross-functional teams that may include clinicians, scientists, regulatory affairs specialists, data management personnel, software developers/engineers, project sponsors/coordinators.

The career path of a Clinical Research Project Manager is very rewarding. You get to use your clinical research expertise to develop new treatments for existing medical conditions and to create new treatments for future medical needs. Additionally, you get to work with leading doctors, scientists, and other professionals who are working towards improving healthcare outcomes. You also have the opportunity to build relationships with key stakeholders including pharmaceutical companies, governmental agencies, and funding bodies which leads to greater satisfaction in your career.

Research project managers are responsible for planning and executing research studies throughout their entire life cycle. This includes activities such as designing experiments or surveys, selecting appropriate experimental methods or sampling techniques, recruiting participants for studies or surveys, collecting data from multiple sources, analyzing results using statistical methods or software programs, interpreting results and preparing recommendations for further action.

The clinical project manager definition refers to a professional who is in charge of developing clinical research activities from the beginning to the end. This includes making a plan for the scope and timeline of the research project; making sure that the project meets all regulatory requirements; organizing the technical aspects of data collection; coordinating meetings between stakeholders; monitoring progress and deadlines; utilizing risk management processes; providing guidance to staff members; ensuring quality control of data collection processes; providing reports to stakeholders and company executives regarding project status updates as needed.

Working as a clinical project manager can be challenging due to the complexity of the tasks involved. Clinical projects require significant planning, coordination and supervision between multiple stakeholders. Additionally, time management can be difficult due to deadlines that must be met and ever-changing regulatory requirements. Other challenges include managing competing priorities and ensuring proper communication between team members. It is also important for clinical project managers to stay current on trends, technologies and best practices within their field so that they can remain competitive in their work.

The core duties of a clinical project manager vary depending on the industry but typically include planning and organizing activities related to assigned projects; developing budgets; coordinating resources; monitoring progress; overseeing quality control standards; ensuring adherence to safety procedures; providing leadership for teams; communicating with stakeholders throughout the duration of the project; developing plans for corrective action if needed; preparing reports for upper management; analyzing data related to performance metrics; maintaining records of all activities related to assigned projects; and staying informed of changes in regulations relating to their area of expertise.

To be a good clinical project manager, it is important to have experience working in healthcare, like in a hospital. It is also helpful to be good at organizing and communicating, as well as understanding the medical environment and the rules that govern it. Additionally, clinical project managers should know about principles related to project management, like budgeting, scheduling, and risk management. Those who have earned a healthcare-related degree or certificate (like in nursing or health information management) may have a better chance of being successful in the role.

A clinical project manager oversees clinical research studies from design through implementation. This includes working with teams of physicians, pharmacists, nurses, statisticians or other health professionals. Responsibilities include making sure the project runs smoothly while staying within the budget and timeline. As part of their role they must understand FDA regulations when conducting trials in the US or ICH guidelines when conducting international studies. Additionally they must be able to identify potential risks associated with each study and develop strategies for mitigating them throughout all stages of the study process.

The average salary for a Clinical Project Manager is approximately $85,000 per year. Hourly pay for Clinical Project Managers usually ranges from around $41 to $58 per hour, with an average rate of approximately $49.50 per hour. Monthly salaries typically range from around $7,083 to $9,833 per month or more.

•Clinical Project Manager – Research and Development: This person is responsible for making sure clinical research studies are organized and run smoothly. • Senior Clinical Project Manager: This person provides guidance to project teams and management when they are developing clinical research projects. • Global Clinical Trial Program Manager: This person creates global clinical trial plans that meet operational requirements while following regulatory guidelines. • Clinical Data Management Project Manager: This person oversees all aspects of data collection, management, analysis and reporting associated with a clinical research project from start to finish. • Regulatory Affairs/Clinical Project Manager: monitors and reports on the regulatory submissions for clinical trials taking place in different countries. • Clinical Operations Project Manager:: oversees and coordinates the daily operations of clinical research projects to ensure that they meet quality assurance standards set out by IRBs or FDA .

Achieving certification as a Clinical Project Manager is a way to show that you are an expert in project management within the healthcare and medical research industries. This certification allows individuals to demonstrate their understanding of clinical project management concepts and skills, which are necessary for ensuring successful outcomes for initiatives within complex clinical research environments. To obtain a Clinical Project Manager Certification, you need extensive knowledge and experience in clinical project management, which can be obtained through formal education, training courses, and hands-on experience.

Certification as a clinical project manager provides healthcare professionals with the skills and knowledge necessary to effectively manage complex clinical trials, research projects, and quality improvement initiatives. There are several key reasons to get certified, including professional credibility, a competitive edge in the job market, increased knowledge base, improved efficiency in completing tasks related to clinical project management, and networking opportunities.

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Clinical trials: A significant part of cancer care

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By Mayo Clinic staff

A cancer diagnosis is an emotional experience. Learning that you have cancer can create feelings of hopelessness, fear and sadness. This is especially true if your cancer is advanced or available treatments are unable to stop or slow its growth.

"Often, when patients are diagnosed with cancer , they feel hopeless and scared. Clinical trials are one way patients can be proactive. They can make a choice in how their care is going to be," says Matthew Block, M.D., Ph.D. , a Mayo Clinic medical oncologist.

Cancer clinical trials help physician-scientists test new and better ways to control and treat cancer. During a clinical trial, participants receive specific interventions, and researchers determine if those interventions are safe and effective. Interventions studied in clinical trials might be new cancer drugs or new combinations of drugs, new medical procedures, new surgical techniques or devices, new ways to use existing treatments, and lifestyle or behavior changes.

Clinical trials provide access to potential treatments under investigation, giving options to people who otherwise may face limited choices. "Clinical trials open the door to a new hope that maybe we can fight their cancer back and give them a better quality of life," says Geoffrey Johnson, M.D., Ph.D. , a Mayo Clinic radiologist, nuclear medicine specialist and co-chair of the Mayo Clinic Comprehensive Cancer Center Experimental and Novel Therapeutics Disease Group.

You will receive cancer treatment if you participate in a clinical trial. "I think one common misperception about clinical trials is that if you enter a clinical trial, you may not get treatment (receive a placebo). And that's actually very much not true. Most clinical trials are looking at one treatment compared to another treatment," says Judy C. Boughey, M.D. , a Mayo Clinic surgical oncologist, chair of Breast and Melanoma Surgical Oncology at Mayo Clinic in Rochester, Minnesota, and chair of the Mayo Clinic Comprehensive Cancer Center Breast Cancer Disease Group.

"I think one common misperception about clinical trials is that if you enter a clinical trial, you may not get treatment (receive a placebo). And that's actually very much not true. Most clinical trials are looking at one treatment compared to another treatment." Judy C. Boughey, M.D.

Watch this video to hear the experiences of people who have participated in cancer clinical trials and to hear Drs. Block, Johnson and Boughey discuss the importance of clinical trials in cancer care:

Clinical trials are a significant part of cancer care at Mayo Clinic Comprehensive Cancer Center. Cancer care teams work together across specialties to make sure the right clinical trials are available to serve the needs of people with cancer who come to Mayo Clinic.

"We are very particular in how we select the clinical trials that we have available for patients," says Dr. Boughey. "We want to have the best trials available for our patients. Some of the clinical trials are evaluating drugs — we are so excited about those drugs, but we can't prescribe those drugs for patients without having that trial. And so we will actually fight to try to get that trial open here to have it available as an opportunity for our patients."

If you choose to participate in a clinical trial, you will continue to receive cancer care. "For most patients that we evaluate, there's always the standard of care treatment option for those patients. And then, in many situations, there's also a clinical trial that the patient can participate in," says Dr. Boughey.

People who participate in clinical trials help make new and better cancer care available for future patients. The treatments available for cancer patients today exist because of the clinical trial participants of yesterday. "We couldn't advance medicine if it wasn't for people volunteering for trials. And the promise from our side is to say we're not going to put patients on trials or offer trials for them to consider unless we think there's a good chance that they'll get a benefit or that society at large will get a benefit," says Dr. Johnson.

"We couldn't advance medicine if it wasn't for people volunteering for trials. And the promise from our side is to say we're not going to put patients on trials or offer trials for them to consider unless we think there's a good chance that they'll get a benefit or that society at large will get a benefit." Geoffrey Johnson, M.D., Ph.D.

Participating in a clinical trial may give you access to cutting-edge treatment, improve your quality of life and extend your time with loved ones.

"It's definitely worth reaching out to your healthcare provider and asking, 'What clinical trials could I be a potential candidate for?'" says Dr. Boughey. "And remember, you can ask this of your surgical oncologist, your medical oncologist, your radiation oncologist, or any of the physicians you're seeing because there are trials in all disciplines. There are also ongoing trials that require the collection of tissue or the donation of blood. They can also be important in trying to help future generations as we continue to work to end cancer."

Participating in a clinical trial is an important decision with potential risks and benefits. Explore these FAQ about cancer clinical trials, and ask your care team if a clinical trial might be right for you.

Learn more about cancer clinical trials and find a clinical trial at Mayo Clinic.

Join the Cancer Support Group on Mayo Clinic Connect , an online community moderated by Mayo Clinic for patients and caregivers.

Read these articles about people who have participated in clinical trials at Mayo Clinic:

• A silent tumor, precancerous polyps and the power of genetic screening
• Mayo Clinic’s DNA study reveals BRCA1 mutations in 3 sisters, prompts life-changing decisions

Read more articles about Mayo Clinic cancer research made possible by people participating in clinical trials.

Related Posts

Drs. Terry Burns and Alfredo Quiñones-Hinojosa discuss brain tumors called gliomas and the hope being offered by new technology and clinical trials.

Dr. Sujay Vora is studying a new approach to glioblastoma treatment that is improving health outcomes and quality of life for elderly people like Richard Casper.

Dr. S. John Weroha discusses new treatments and research that are helping more people survive ovarian cancer.

REVIEW article

Project stakeholder management in the clinical research environment: how to do it right.

• 1 Department of Population Health, New York University Medical Center, New York, NY, USA
• 2 Department of Management, Zicklin School of Business, Baruch College, New York, NY, USA
• 3 District Mental Health Programme, Madurai Medical College, Madurai, India
• 4 Division of Community Psychiatry, M. S. Chellamuthu Trust and Research Foundation, Madurai, India
• 5 University of Virginia Darden School of Business, Charlottesville, VA, USA
• 6 Department of Neuropsychiatry and Behavioral Science, University of South Carolina School of Medicine, Columbia, SC, USA
• 7 University of South Carolina, Columbia, SC, USA

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK ® of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article.

A true architect is not an artist but an optimistic realist. They take a diverse number of stakeholders, extract needs, concerns, and dreams, and then create a beautiful yet tangible solution that is loved by the users and the community at large. We create vessels in which life happens

– Cameron Sinclair ( 26 )

In recent years, a revolution in thinking about organizational management and decision making has taken place. Increasingly, programs have been incorporated into organizations, typically private sector corporations or government agencies, which have sought to involve “stakeholders” in management decision making. Stakeholders are the customers, suppliers, the general public, and any other group, which are likely to be affected by the organization’s ultimate decisions. The process of incorporating the ideas and input from these groups has been termed “stakeholder engagement.” It reflects an increasingly accepted attitude that organizations not only have an ethical obligation to involve the participation of stakeholders in their collective activity but also in so doing their overall organizational effectiveness will be enhanced. While certain generalizations in the application of this philosophy are constant, minor variations also exist, which reflect the specific goals that the organization is pursuing. In this review, the application of stakeholder engagement in clinical research settings, particularly in hospitals or university research centers, is considered.

According to the Institute of Medicine (IOM), the purpose of comparative effectiveness research (CER) is, “to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve healthcare at both the individual and population level” ( 1 ). The Kellogg Commission report defines engagement as follows: “By ‘ engagement ’ we refer to institutions that have redesigned their teaching, research, and extension and service functions to become even more sympathetically and productively involved with their communities, however, community may be defined” ( 2 ). Hospitals and research centers are increasingly taking deliberate steps to include their broader constituencies in project management decision making and to seek their input at an early stage of the research or program implementation process. The term “ community engagement ,” can be defined as, “the process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the well-being of those people” [( 3 ), p.3]. It has been noted that traditional models of research which view study subjects or targets of program development as passive audiences may result in research findings that are poorly aligned with the information needs of real-world decision makers ( 4 , 5 ). An additional impetus for this interest has been the Patient Protection and Affordable Care Act of 2010, which was enacted to promote patient engagement. The purpose of the act has been to help patients, clinicians, purchasers, and policy makers make better informed health decisions by “advancing the quality and relevance of evidence about how to prevent, diagnose, treat, monitor, and manage diseases, disorders, and other health conditions.”

The key focus in the process of stakeholder engagement is of course the stakeholder. Freeman ( 6 ): 46 defined stakeholder as, “any group or individual who can affect or is affected by the achievement of the organization’s objectives.” According to the project management institute (PMI), the term stakeholder refers to, “an individual, group, or organization, who may affect, be affected by, or perceive itself to be affected by a decision, activity, or outcome of a project” ( 7 ). In other words, almost any individual or group of individuals with an interest or stake in a consensus-building process thereby the outcome of the project and/or an ability to exert a positive or negative influence by the execution or completion of a project or being affected by the work or its deliverables, outputs, or results.

In clinical research, researchers are often faced with questions about the choices that must be made by patients. Research can also be focused on assisting the process of program development. In either instance, the underlying motivation remains the same: to healthcare delivery, to become aware of dysfunctionalities that may exist in healthcare, and to improve the outcomes of proposed changes. It is essential then that research and program processes are assisted by those who are most directly affected by proposals, i.e., the patients themselves. Central to the process of encouraging stakeholder involvement therefore is a basic assumption that patients have the right to make the best decisions about their own health care.

Stakeholder engagement versus stakeholder management (ShM): in recent years, the term “ stakeholder engagement ” (ShE) has become widely used in applied clinical research and new program development. An important reason for this is that it has been repeatedly shown that critical health issues, which are often known to the patients or research subjects themselves, may not have been addressed in the original research or program proposals ( 8 ). Stakeholder engagement is a bidirectional process. It begins when the researcher communicates and interacts with stakeholders, and ultimately results in informed decision-making concerning the selection, conduct, as well as dissemination of research findings in order to achieve a desired outcome and enhance accountability ( 9 , 10 ). Stakeholder engagement is thus differentiated from one-way communication processes that seek to influence groups to agree with a decision that has already been made.

The obligation to serve all stakeholder interests is often called stakeholder management ( 11 , 12 ). The main distinction between stakeholder management and stakeholder engagement largely rests on the extent to which stakeholders are involved in the decision-making processes. The process of engagement varies across different research programs, but is highly noticeable in complex, multidisciplinary research.

A stakeholder analysis is a process, which provides insights into, and understanding of, the interaction between a project and its stakeholders. In other words, the process of listing, classifying, and assessing the influence of these stakeholders in a project is termed a stakeholder analysis. Stakeholder analysis systematically gathers and analyzes both qualitative and quantitative information thereby to determine whose interest should be taken into account throughout the project. One of the first tasks that a clinical project manager must undertake is to identify how stakeholders can make the greatest impact on the research project or program change, which is being contemplated. The function of stakeholder analysis is to produce an awareness of who will be affected by the project and who can contribute to making the project more successful. The stakeholder analysis, which is usually undertaken at an early stage of planning, is an integral part of risk and reward assessment activities.

It is essential for maximal project effectiveness that managers be committed to the basic philosophy of stakeholder involvement. Project managers must communicate and impart what they see as their goals but also seek to encourage participation by stakeholders so that their perspectives are included in decision making.

The process of identifying, engaging stakeholders must begin well in advance so that dialog is seen to play an important part of project implementation; no decisions should be already made before commencing stakeholder engagement on project-related issues.

Benefits of Stakeholder Engagement

Well managed projects, although long and complex, create long-term economic gain and social values meaning that proper use of taxpayer’s money. When done correctly, stakeholder engagement provides opportunities to further align clinical research practices with societal needs, values, and expectations, helping to drive long-term sustainability and stakeholder interests.

Stakeholder engagement is intended to help administrators fully realize the benefits of applying community and patient interest in hospital programs, and to ensure that research and program changes benefit those who are most directly affected.

The stakeholder focus group is a communication medium through which the opinions of individuals or groups of individuals who are impacted by the research can be elicited. Focus groups can also serve to clarify each stakeholder’s role and responsibilities, as well as promoting an overall understanding of the project requirements. Such processes also provide stakeholders with an environment in which they can express their opinions and feel that they have been heard.

In a series of related manuals the Patient-Centered Outcomes Research Institute (PCORI) ( 13 ) has provided a group of examples of how hospitals and medical clinics can encourage stakeholder involvement, in various research projects or programs whose aim was to improve the quality of medical services.

It can be seen from one of our case studies (see Appendix) that stakeholders can make meaningful contributions to a project when opportunities are structured to encourage their participation. The process of encouraging stakeholder participation is referred to as stakeholder management.

Requirements for Stakeholder Management

Stakeholder management involves the processes of identifying (both internal as well as external) stakeholders; assessing stakeholders’ skills, knowledge, and expertise; determining stakeholders’ requirements; determining stakeholders’ interests and expectations; determining stakeholders’ communication needs; addressing stakeholders’ issues and concerns as they occur; maintaining a positive relationship and communicating with stakeholders throughout the project; identifying stakeholders’ influence-controlling strategies; making sure that stakeholders are involved in the project at the required level throughout the project; and confirming continuous interactions with the stakeholders. In the area of clinical research patients and other stakeholders such as physicians, clinicians, nurses, and others have critical roles to play. Clinical researchers at the outset of research need to ask for patient participation in the development of research questions. Researchers need to find out the exact characteristics of study participants and to define what the nature of the research outcomes should be. In this process, contributions from patients are helpful and often critically important for project success. The process of carrying out research also involves measuring the results of research interventions and monitoring the progress of the research, especially in terms of whether or not it is being directed toward the initial intentions of the research. Finally, patients, who are often very closely connected with the target populations of the research, have a direct perspective on how the targets of the research will respond to the research recommendations, and therefore, can provide useful inputs for insuring its relevancy.

Project Stakeholder Management Processes

The PMI identifies four key processes that are associated with the stakeholder management knowledge area in initiating, planning, executing, and monitoring and controlling process groups ( 7 ) (Table 1 ).

Table 1 . Four project stakeholder management processes and key outputs .

Identify Stakeholders

This entails identifying all people or organizations impacted by the project and documenting relevant information regarding their interests, expectations, involvement, and influence on project success. In the hospital setting, the stakeholders are usually the patients, but can also be healthcare professionals and the families of patients. Examples of stakeholders are given in Table 2 .

Table 2 . The stakeholders can be categorized or classified in many different ways for different purposes .

Throughout the project the following critical tasks should be carried out.

All internal and external stakeholders should be identified. These will usually be the patients but often will include the patients’ family members, healthcare providers, or program administrators.

Stakeholders’ interests, requirements, and expectations should be identified. Obviously, patients are interested in the effects of proposed program changes or research outcomes on their health and well-being, but may have additional interests such as hoping to improve their employment prospects, or expanding their range of capabilities. Clinical researchers and administrators should be alert to these concerns and take appropriate steps to address them. It has been found, for instance, that stakeholder views at the beginning of a program evaluation process may be provisional or may change as a result of additional information. Additionally, stakeholders’ interests may change over time. In one study, the results of pre-workshop and final workshop voting often differed, suggesting that prioritization efforts relying solely on requests for topics from stakeholder groups without in-person discussion may provide different research priorities ( 14 ). Thus, efforts should be made to audit the evolving nature of stakeholders’ expectations and preferences through structured methods.

All stakeholders’ levels of influence should be determined. It is often the case that patients and other beneficiaries of program development have talents and skills that may not be reflected in records of formal education or social standing. Certain personal traits, which patient stakeholders may possess, such as communication skills or life experience, could nevertheless prove invaluable for achieving project goals.

A communication plan for the stakeholders should be determined. Patient stakeholders may not always be familiar with or comfortable in using traditional channels of communication in large organizations. As noted by Lavallee et al. ( 15 ), the increasing availability of mobile technology, social media, internet venues, and electronic devices has multiplied the communication options for many, but carries with it the risk of increasing the quantity of participants while reducing the depth of involvement. Often, the use of focus groups or small informal meetings can be used to increase the quality of communication or to elicit participation from those who might otherwise be reticent about expressing their views. Reviews of methods of communication for engaging stakeholders have concluded that a combination of approaches probably yields the best results. Methods such as voting or using ranking procedures such as the analytic hierarchy process ( 16 ) and other structured techniques are best for establishing research priorities, whereas in-person methods are best for clarifying ideas and generating ideas ( 17 ). Repeated exposure to these experiences be useful for identifying patient stakeholders’ core concerns and for acclimatizing them to organizational communication.

Stakeholders’ expectations and influence over the project should be managed. Reality checks are important for balancing patients’ idealistic expectations and the necessity of dealing with the challenges of getting things done through institutions. Program administrators must identify patient stakeholders’ strengths and channel these for optimal organizational impact.

Depending on their complexity, size, and type, most projects have a diverse number of internal and external stakeholders at different levels of the organization with different authority levels.

Stakeholder identification is a dynamic and sometimes difficult process, and the influence of a stakeholder may not become evident until later stages of a project. And, sometimes projects evolve so that solving unseen problems emerges as a critical task. It is essential to identify as many as stakeholders as possible at the beginning of the project and classify them according to their level of interest, influence, importance, and expectations at the earliest stages of the project as much as possible (Table 3 ). The identification of the relevant stakeholders is not only a core necessity but also poses a significant challenge. For example, under cost constraints, it might not be possible to identify all external stakeholders ( 18 ). On the other hand, stakeholders who are missed out during the identification process might have special requests to be fulfilled. This could potentially delay the project completion or escalate the cost as their requirement needs to be fulfilled. Additionally, as Bryson ( 19 ) pointed out that the failure to attend to the information concerns of stakeholders clearly is a kind of flaw in thinking or action that too often and too predictably leads to poor performance outright failure or even disaster.

Table 3 . Stakeholder management strategy .

As per the PMBOK ® , the “Identify Stakeholders” process has the following inputs, tools and techniques, and outputs:

Project Charter

The project charter gives an overall picture of the project as well as describing some of the stakeholders and their interest in the project along with their requirements.

Procurement Documents

If a project is based on an established contract or the result of a procurement activity, the parties in that contract are key project stakeholders. Other relevant parties such as suppliers, legal parties, and people who will execute the contract should also be considered as part of the project stakeholders list.

Enterprise Environmental Factors

Hospital culture and structure, and other factors may influence the identify stakeholders process.

Organizational Process Assets

To benefit from previous experience those in charge of developing proposals should carefully review the efforts of earlier projects. The stakeholder register template, lessons learned, and the stakeholder registers from previous projects may influence the identify stakeholders process.

Stakeholder Analysis

It is not possible to treat all stakeholders equally in the project, and they are given different priorities with respect to their interests, expectations, and influence on the project. Stakeholder analysis is a process of systematically gathering and analyzing all relevant quantitative and qualitative information about the stakeholders in order to prioritize them and determine whose interests should be taken into consideration throughout the project.

As per PMI, stakeholder analysis is performed by the following steps:

Step 1: all potential project stakeholders and their relevant information, such as their roles, interests, knowledge levels, expectations, and influence levels should be identified.

Step 2: the potential impact or support each stakeholder can contribute should be identified. As per the PMBOK ® , there are several classification models below:

• Power/interest grid: this is based on the level of authority or power and the level of concern or interest that a stakeholder has regarding the project outcome (Figure 1 ).

• Power/influence grid: this is based on the level of authority or power and active influence a stakeholder has.

• Influence/impact grid: this groups stakeholders based on their involvement or influence and their ability to affect changes to planning or execution (impact).

• Salience model: this addresses a stakeholder’s power or ability to impose their will, urgency, or need for immediate attention from the team and legitimate involvement in a project.

Step 3: in order to influence the stakeholders to enhance their support and to mitigate potential negative impacts, the way in which key stakeholders are likely to react or respond in various situations should be assessed.

Figure 1. Stakeholder mapping: the power versus interest grid . The gird shows stakeholders on a two-by-two matrix showing the strategies to be employed to engage and manage them. Power/interest grid model shows the grouping of the stakeholders based on their level of authority (“power”) and their level or concern (“interest”) regarding the project outcomes. Identifying and classifying the stakeholders is pivotal as it helps to develop appropriate strategies to effectively engage and manage all the stakeholders involved in a particular project. This also provides a clear-cut strategy and action-oriented and workable plan to interact with the all the stakeholders in an effective manner so as to minimize the resistance and maximize the support. A project is as successful as the stakeholders think it is. The details of power versus interest grids are found elsewhere ( 25 ).

Stakeholders who have greater power or influence and a strong interest in the project should be managed closely and continuously updated. Stakeholders who have significant power but low interest in the project should be kept informed about the project. Stakeholders who have low power and low interest should be monitored, and stakeholders who have low power and high interest should be kept satisfied.

Expert Judgment

Judgment and expert opinions can be gathered to identify stakeholders, usually from the senior management. These resources can include project team members, project managers from similar projects, subject matter experts, industry groups and consultants, and other units within the hospital or research setting.

Profile analysis meetings with team members and the sponsor will be beneficial for identifying stakeholders and their knowledge, potential roles, importance, impact, interest, and expectations in the project.

Stakeholder Register

This contains all details related to the identified stakeholders including but not limited to

• Stakeholder classification: stakeholders can be classified in many different ways. For example, primary (users of the products, services, or results) or secondary (may not be the direct users, but have some influential relationship), Internal/external, neutral/resistor/supporter/hard to hear, and so on.

• Identification information: name, title, location, organization, role in the project, position, and contact information.

• Assessment information: key requirements and expectations, potential impact, importance, and influence on the project.

A project manager may publish the stakeholder register with other project documentation or keep it in reserve for personal use only (Table 4 ).

Table 4 . A snapshot of a stakeholder register: stakeholder register is a project document, which is an output of identify stakeholders process .

Plan Stakeholder Management

The plan stakeholder management process defines an approach for managing stakeholders throughout the entire project life cycle as per their interest, impact, importance, and influence over the project. It defines the strategies for building close relationships with stakeholders who can benefit the project and for minimizing the influence of stakeholders who may have a negative impact on the project.

This process is iterative and should be reviewed on a regular basis as the required level of engagement of the stakeholders’ changes in the project.

As per the PMBOK ® , the Plan Stakeholder Management process has the following inputs, tools and techniques, and outputs:

Project Management Plan

Components of the project management plan (PMP) such as the human resource management plan, staffing management plan, communications management plan, change management plan, and others are used in developing the stakeholder management plan (SMP).

This contains all details related to the identified stakeholders, including identification information, assessment information, and classification.

All environmental factors within the hospital or clinical research facility, including its culture and history of the organization, are used.

All organizational process assets, especially lessons learned and historical information are used.

Judgment and expert opinions can be gathered from senior management, project team members, identified stakeholders, project managers from similar projects, subject matter experts, industry groups and consultants, other units within the organization, and other people to identify the level of involvement required from each stakeholder at various stages of the project. However, it is possible that expert judgment can be mistaken when possible expert judgment must be balanced with input from the stakeholders themselves.

Meetings with team members and the sponsor will be beneficial for identifying the level of engagement required from each stakeholder.

Analytical Techniques

Various analytical techniques are used for identifying the required level of stakeholder engagement. These techniques take into consideration stakeholder sensitivity to project goals and personal orientations such as being unaware, resistant, neutral, supportive, or providing leadership.

Stakeholder Engagement Assessment Matrix

The stakeholder engagement assessment matrix (SEAM) is used to assess the current and desired state of engagement of a stakeholder for the current phase of the project (Table 5 ).

Table 5 . Stakeholder engagement assessment matrix (SEAM): please note that the current and desired engagement level of key stakeholders expect to change as the project progresses and develops .

The SEAM illustrates that only Stakeholder 4 is engaged in the project at the desired state. The project manager should consider additional communication and further actions to bring all other stakeholders to the supportive and leading states.

Stakeholder engagement is critical to project success; thus, required actions and communication should be planned to minimize the gap between the desired level of engagement and the actual level of engagement.

Stakeholder Management Plan

Stakeholder management plan, which is a subsidiary plan of the PMP that defines the processes, procedures, tools, and techniques to effectively engage stakeholders in project decisions and execution on the analysis of their needs, interests, and potential impact ( 7 ). The SMP can be formal, informal, highly detailed, or broadly framed based on the needs of the project. The SMP typically describes the following:

• information needs of each stakeholder or stakeholder group;

• stakeholder communication requirements;

• format, method, time frame, and frequency for the distribution of required information to the stakeholders;

• person responsible for communicating the information to the stakeholders;

• methods of refining the SMP;

• required engagement level of the stakeholders at various stages of the project;

• stakeholder management strategy that defines an approach to manage stakeholders throughout the entire project life cycle. It defines the strategies to increase the support of the stakeholders who can impact the project positively and minimize the negative impacts or intentions of the stakeholders who can negatively impact the project.

The portion of the plan that contains sensitive information such as stakeholders’ personalities and attitudes, negative impact that stakeholders may cause, or other factors is not usually published and is kept in reserve by the project manager for personal use only.

Project Documents Updates

Project documents such as the project schedule, stakeholder register, and others may be updated.

Manage Stakeholder Engagement

The Manage Stakeholder Engagement process is focused on meeting and exceeding the stakeholders’ expectations by continuously communicating with them, clarifying and resolving their issues, addressing their concerns, and improving the project performance by implementing their change requests.

As per PMI, the project manager is responsible for managing the stakeholders’ expectations. Meeting the stakeholders’ expectations increases the probability of project success by enabling the stakeholders to be active supporters of the project, drastically reducing unresolved stakeholder issues, and limiting disruptions in the project.

As per the PMBOK ® , the Manage Stakeholder Engagement process has the following inputs, tools and techniques, and outputs:

Within the research context, the SMP identifies information needs, communication requirements, required engagement level at various stages of the project, stakeholder management strategy, and other factors to identify and manage stakeholders throughout the entire project life cycle.

Communications Management Plan

The communications management plan is a subsidiary of the PMP. It can be formal, informal, highly detailed, or broadly framed based on the needs of the project. The communications management plan typically describes the following: purpose for communication; Information needs of each stakeholder or stakeholder group; stakeholder communication requirements; format, method, time frame, and frequency for the distribution of required information; person responsible for communicating the information; methods for updating the communications management plan; persons or groups who will receive the information; glossary of common terms; issues/concerns escalation procedures.

A change log is used to document changes that occur during a project. A lot of these changes can impact different stakeholder interests; thus, the change log is reviewed in this process.

Organization communication requirements, issue management procedures, change control procedures, and historical information are used.

Communication Methods

According to the needs of the project, the methods of communication identified for each stakeholder in the communications management plan are utilized during the manage stakeholder engagement process.

Interpersonal Skills

The project manager applies appropriate interpersonal skills or soft skills to manage stakeholder expectations by building trust and resolving conflict.

Management Skills

Management skills such as presentation skills, negotiation skills, writing skills, and public speaking skills used by the project manager can greatly influence how stakeholders feel about the project.

An issue is an obstacle that threatens project progress and can block the team from achieving its goals. An issue log is a written log document to record issues that require a solution. It helps monitor who is responsible for resolving specific issues by a target date. There should be one owner assigned for each issue reported within the project.

Change Requests

Change requests can include a new change to the product or the project, corrective or preventive actions, and other items.

Project Management Plan Updates

The SMP portion of the PMP is updated as new stakeholders’ requirements are identified, existing requirements are changed, or as a result of addressing concerns and resolving issues of the stakeholders.

Project documents that may be updated include, but are not limited to, the following:

• Issue log: this will be updated as resolutions to the current issues are implemented and new issues are identified.

• Stakeholder register: this is updated as stakeholders’ statuses change, new stakeholders are identified, registered stakeholders are no longer involved or impacted by the project, and other factors.

Organizational Process Assets Updates

Lessons learned from managing stakeholders, feedback from stakeholders, project records, causes of issues, and reasons for corrective actions chosen may be updated.

Control Stakeholder Engagement

The control stakeholder engagement is the process of evaluating and monitoring overall stakeholder relationships and ensuring stakeholders’ appropriate engagement in the project by adjusting plans and strategies as required. As the project progresses and its environment changes, this process will maintain or increase the efficiency and effectiveness of stakeholder engagement activities.

As per the PMBOK ® , the Control Stakeholder Engagement process has the following inputs, tools and techniques, and outputs:

Components of the PMP such as the human resource management plan, staffing management plan, communications management plan, change management plan, and others are used in controlling stakeholder engagement.

An issue is an obstacle that threatens project progress and can block the team from achieving its goals. An issue log is a written log document to record issues that require a solution. A modified issue log is developed as a result of identifying new issues and resolving current issues.

Work Performance Data

Work performance data such as resource utilization, deliverables status, schedule progress, percentage of work completed, number of defects, number of change requests, technical performance measures, costs incurred, quality updates, and other factors are used in this process.

Project Documents

Project documents such as issue logs, the stakeholder register, the project schedule, the change log, and others are used in this process.

Information Management Systems

An information management system is an automated system that can serve as a repository for information, a tool to assist with communication, and a system for tracking documents and deliverables. An information management system also supports the project from beginning to end by collecting and distributing information about cost, schedule, and performance for the stakeholders. Several reporting techniques such as spreadsheet analysis, table reporting, presentations, graphics for visual representations, and others may be consolidated from various systems and communicated to the stakeholders.

Judgment and expert opinions can be gathered from senior management, project team members, identified stakeholders, project managers from similar projects, subject matter experts, industry groups and consultants, other units within the organization, and other people to identify new stakeholders, reassess the current stakeholders, and figure out the level of involvement required from each stakeholder at various stages of the project.

Status review meetings with the team, sponsor, and other stakeholders will be beneficial for reviewing information about stakeholder engagement.

Work Performance Information

Work performance information such as deliverables status, change request implementation status, and forecasted estimates to completion are distributed through communication processes.

These are recommended corrective actions for bringing the imminent performance of the project as per the expectations in the PMP and recommended preventive actions for reducing the probability, and impact of future negative project performance will generate a lot of change requests.

Most of the components of the PMP may be updated to reflect changes in the stakeholder management strategy and the approach to effectively control stakeholder engagement in the project.

Project documents such as the issue log, the stakeholder register, and others may be updated.

Lessons learned from managing stakeholders, feedback from stakeholders, project records, causes of issues, reasons for corrective actions chosen, project reports, stakeholder notifications, and other items may be updated.

While the burden of disease is growing rampantly and disproportionately, the challenge to global health outreach efforts is to prioritize those illnesses, which require immediate attention. The global health equity sorts to prioritize on improving health care and achieving equity in health of people around the world. In this context, researchers from high income countries often study the existing diseases and/or emerging challenges in low income countries in order to gain expertise on the health care needs ( 20 ). In this regard, it is essential for overall program effectiveness that representatives of local communities, the stakeholders who will be most impacted by health outreach programs, be invited to provide their insights into which health needs are greatest. The encouragement of ShE and ShM often has a secondary benefit inasmuch as organization’s reputation is subsequently enhanced, which further facilitates organizational effectiveness. The very presence of stakeholders may foster an organizational environment, which encourages relevancy of program objectives to stakeholders’ expectations, a coupling, which in turn contributes to achievement of the project’s goals. Additionally, stakeholders can provide reality checks, which aid in the prioritizing of research objectives, in identifying potentially difficult political issues, and in providing the means to navigate around or to overcome challenges. The experience of stakeholders is thus invaluable for guiding research and achieving program objectives from their early stages in the laboratory to their final clinical application.

Although the process of partnering with stakeholders in clinical research settings is still in its nascent stages, it is anticipated that it will increasingly become accepted and implemented by project managers. In tandem with this process, greater efficiency and transparency will develop in working with stakeholders to meet targets ( 21 ). Part of the function of stakeholder analysis is to promote an understanding of stakeholders and to ensure that their expectations are being met. It is anticipated that project heads will increasingly encourage an awareness (ensuring transparency) of who will be affected by the project and who can contribute to making the project more successful.

Stakeholders have unique perspectives and often possess a number of capabilities which they have acquired from life experience. Program developers can derive the maximum benefit from stakeholders if the proper context is established for drawing out this experience. Alternatively, barriers to effective participation by stakeholders can occur if managers remain unaware of stakeholders’ skills, or if they believe that they do not have appropriate knowledge to contribute.

By increasing the acceptability of programs, stakeholders increase the likelihood of their success. Stakeholders play pivotal roles as healthcare advocates or healthcare ambassadors, partners, and/or agents of change. Although stakeholders differ considerably in their expertise and interests, their involvement is pivotal inasmuch as it can facilitate the successful completion of projects. Stakeholder participation can (a) improve relevance; (b) promote visibility and research transparency; (c) accelerate and translate the research findings to real-world challenges; (d) enhance greater project acceptance as confidence derived in the decisions made during the project’s milestone developments. Similarly, the project’s final outcome can only be considered successful when it is acknowledged by its key stakeholders.

Due to the broad range of ways in which stakeholders can influence program development, it is essential that their behavior be closely monitored, and modulated if necessary. One of the advantages of the described system of viewing the management of stakeholder engagement is that it documents many processes that have taken place. Future efforts to manage this type of engagement can therefore benefit from established experience.

In a nutshell, as Wheeler et al. ( 22 ) pointed out, “a truly stakeholder-responsive approach demands the acceptance of multiple stakeholders and requires that an organization develop a tolerance for ambiguity together with the sensitivities and capabilities needed to inspire trust with diverse and sometimes completing interests.”

A balanced assessment recognizes that certain caveats apply in the establishment of stakeholder engagement and management in clinical and research settings. These relate to the unique nature, demands, resources, and implementation issues which every organization has and how these demands can interact with the unique skills and abilities which stakeholders bring to it.

Many investigators lack clear or a basic understanding and/or training concerning the stakeholder framework as well as terminologies (Figure 2 ).

Figure 2. Project stakeholder management summary .

Often a reactive approach is favored over a proactive one for dealing with stakeholder issues is favored over a proactive one. As suggested by Greenwood, the “glorified depiction of stakeholder engagement gives way to the murky reality that engagement of stakeholders can mean many things to many people” ( 23 ). In this conceptualization, stakeholders may be viewed merely as actors with whom project managers form arms-length transactions rather making a tightly knitted partnership. This limited perspective may result in a failure to assess, understand the social, spiritual, and environmental needs of stakeholders.

Not every project can require or afford to have a full ShE or ShM system in place as outlined in this review. The main barrier here is that stakeholder involvement, and the fostering of attitudes that encourage this process, require a degree of organizational change (i.e., additional paperwork, more meetings, and more communication), which can be expensive. Hence, the benefits of managing a full program of stakeholder engagement, analysis, and management are only applicable to high impact projects. As Cennamo et al. ( 24 ) have noted a stakeholder-committed organization may still act out of self-interest. Thus, while localized programs may recognize and incorporate contributions from stakeholders and the larger community, these activities may continue to serve institutional objectives, which are narrowly focused or even possibly inimical to broader community interests. Additionally, stakeholder preferences are not absolute, but relative, and may also be evolving. Hence, the salience might change frequently across time. Another issue is that there is no generic “one size fits all” strategy for ShM and ShE, rather, the strategy and its execution depend very much on the local stakeholder landscape, as well as the problems that are being addressed. These include the stakeholder assets that are available and the opportunities that exist for their cultivation. Additionally, a barrier to effective participation and the subsequent consensus-building process is that the identified stakeholders may lack appropriate knowledge or skill sets, or believe, correctly or incorrectly, that they do not have appropriate knowledge to contribute and/or the investigators have the knowledge and experience to identify it. Stakeholders might have multiple perspectives and conflicting views, needs, and priorities. These may eventually result in identifying what they perceive to be the “best” or “appropriate” solution in any given situation, although the course of action might completely differ from that of investigators. This, in turn, results in potential “conflicts” and “trade-offs” in terms of project objectives. For example, the conflicting interest among the stakeholders with varied levels of power, importance, interest, and agenda must be managed efficiently. This poses a challenge to novice project managers to experienced investigators. These may potentially limit control mechanisms, and thus impede organizational performance. On the contrary, it is difficult to generate interest and involvement in projects, which are perceived to have little or immediate relevance. Finally and most importantly, while most of the ShE literature emphasizes the positive benefits of stakeholder engagement, it less frequently addresses the potential costs and risks with the adoption of a stakeholder perspective.

Above all, it is impossible to engage with stakeholders and to do stakeholder management in an authentic and effective way without dealing with the multiplicity of ethical issues that arise. These issues arise, first of all, because the stakeholders’ interests can conflict along key ethical dimensions. Therefore, engaging with them must be sensitive to the rights of the parties involved, as well as to the overall harms and benefits, which accrue from managerial action. Second, it is not always apparent when there may be conflicts of interests or hidden advantages or hidden disadvantages among key stakeholders and decision makers. Obviously, these conflicts must be disclosed, and many organizations have specific procedures for handling such conflicts. However, given the nature of the decisions that are to be made, managers must be willing to accept that effective stakeholder management places them squarely in the realm of ethical decision making.

It is not always possible to anticipate all of the ethical issues and conflicts, which may develop in such a multi-stakeholder environment. Therefore, the traditional method of assigning responsibility for solving these problems to an ethics committee does not always work. Clinical project managers must be willing to make choices based on both good ethics (based on PMI’s code of ethics and professional conduct) and on the overall purpose and values of their institution that is best for all stakeholders ( 27 ). While some ethical issues can be anticipated at the start of the project, all should be subjected to discussion among the project stakeholders to find the best possible course of action.

Assuming that the challenges reviewed above can be overcome, additional “higher order” issues will emerge. These will consist of how to best promote the operational adaptability, viability, and implementation of the changes in an acceptable timeframe. Project managers will need to ask if the benefits of managing a full stakeholder analysis are really greater than the costs associated with it. Efforts will also need to be directed toward retrospective analysis, i.e., did real cases go badly because the stakeholder views were not sought out? The difficulty of these questions varies in different clinical settings but it is essential that they be resolved for maximum project effectiveness.

In summary, the concept of promoting stakeholder engagement and management is a relatively recent one in the clinical research arena; hence, there are many lessons to be learnt in the coming years. As this is an iterative process, although the current efforts from funding agencies such as PCORI are necessary but are insufficient to respond to the above challenges. All indications are that attempts to meet these challenges will nevertheless provide significant benefits for project management effectiveness.

From a clinical standpoint, stakeholder engagement and management is pivotal to the development and deployment of community-oriented national and global health initiatives. The ultimate purpose of such engagement is the efficient use of time, money, and resources thereby positively impact existing and/or emerging healthcare challenges.

For the purpose of our review, we have followed the guidelines of PMBOK ® ( 7 ), which provides a common vocabulary to guide the processes. In doing so, our review outlines a systematic model for planning, managing, and implementing stakeholder engagement based on PMBOK ® guidelines. Further, the application of the project management knowledge, skills, tools, and techniques can augment the chances of success, even in complex projects.

This review has drawn on the experience of stakeholder engagement in private organizations and government agencies and has argued that the process is equally viable in hospital program development and in clinical research. It has taken the view that the concept of stakeholder engagement and a proper stakeholder management framework is more than a useful adjunct to pursuing project or program goals and is actually pivotal for enhancing organizational success.

These guidelines have been broken down into a number of component parts. It emphasizes that the stakeholders should first be identified, that their interests and expectations should be understood, and that their level of power and influence should be understood as well. A plan for communicating with stakeholders has been outlined and techniques for encouraging their participation and management have been laid out.

Author Contributions

All authors intellectually contributed to the design, analysis, and interpretation of the results and to drafting the critical review of manuscript. All authors reviewed and approved the final version of the manuscript.

Conflict of Interest Statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Acknowledgments

The authors would like to sincerely thank Professor Philip Kotler, S. C. Johnson & Son Distinguished Professor of International Marketing, Kellogg School of Management, Northwestern University, USA for his time, advice, and his valuable comments on the earlier versions of our manuscript, which enormously improved the quality of the final manuscript. We are also grateful for the comments from the anonymous reviewers. We gratefully acknowledge the National Institutes of Health; National Institute of Mental Health; Duke Endowment; South Carolina Department of Health and Human Services. As of the end of 2012, the Duke Endowment had provided more than $7.25 million in support of the program. Additional funding has come from the South Carolina Department of Health and Human Services, the National Institute of Mental Health (NIMH), and the National Institutes of Health (NIH). NIMH and NIH awarded two grants (one in 2009 and one in 2012) totaling $3.04 million to support evaluation of project outcomes (on quality, economic impact, utilization, and sustainability). In addition to grant funding, user fees and third-party insurance cover some program-related costs; for example, beginning in 2013, BlueCross BlueShield of South Carolina began covering use of telemedicine in mental health. However, the funders had no involvement in study design, data collection, data analysis and interpretation, preparation of the manuscript, or in the decision to submit the manuscript for publication.

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Appendix: Examples of Stakeholder Engagement

Statewide telepsychiatry initiative.

In one of our landmark study by the author (MN), the South Carolina Department of Mental Health partnered with the University of South Carolina School of Medicine, Department of Health and Human Services and 18 predominantly rural hospitals from the South Carolina Hospital Association to establish the statewide telepsychiatry initiative. In this public-private-academic partnership, the psychiatrists were available via teleconference 16 h a day, 7 days a week, to assess and treat patients with mental health issues at hospital emergency departments.

The clinicians called the psychiatrist on duty whenever they have a patient who needed a mental health assessment and/or counseling and provide relevant medical records and details. Through a secure video link, the psychiatrists were able to assess the patient and makes recommendations about needed treatment and follow-up, including referrals to community-based resources.

The advantage of such program was that, it drastically reduced emergency department wait times, inpatient admissions, as well as costs; increased attendance at follow-up outpatient appointments; and generated higher level of satisfaction among patients and clinicians. Additional evidence includes post-implementation surveys that gauge the satisfaction of patients and clinicians with the program.

In such an innovative approach, the stakeholder (State Department of Mental Health, University of South Carolina, Department of Neuropsychiatry and Behavioral Science, Hospital, Physicians and Nurses from the South Carolina Hospital Association, and Patients) engagement proved to be feasible, necessary, and beneficial in clinical environment.

Outcome of the Initiatives – Did it Work?

The program has reduced emergency department (ED) wait times, inpatient admissions, and costs; increased attendance at follow-up outpatient appointments; and generated high levels of satisfaction among patients and clinicians.

Shorter ED Wait Times: From March 2009 through 2014, the average waiting time for patients with mental health problems at the 18 participating EDs fell by roughly 50%. Fewer hospitalizations: during the same timeframe, 11% of ED patients assessed by a psychiatrist were hospitalized, half of the 22% admission rate among similarly cared-for patients in South Carolina EDs not offering this program.

Health care utilization: Telepsychiatry consultations resulted in an estimated $1,400 less per mental health patient compared to patients seen in ED’s that did not have telepsychiatry due primarily to the reductions in hospital admissions.

Greater attendance at follow-up appointments: About 46% of patients served by the program attended an outpatient follow-up appointment within 30ădays of the initial ED visit, well above the 16% attendance rate among similar ED patients cared for in South Carolina hospitals not offering the program. Similarly, 54% of patients served by the program attended a follow-up appointment within 90ădays versus 20% among ED patients in hospitals not offering the program.

High satisfaction among patients and staff: More than 80% of patients served by the program reported being satisfied with the process and services received. In addition, 84% of ED physicians and staff believe that the program has improved patient care; 91% report being satisfied with program-related procedures; and 84% express satisfaction with the technology used.

How We Did It: Planning and Development Process Key Steps Included the Following:

Decision to focus on telepsychiatry : The increasing popularity of telemedicine and its potential to bring services to underserved geographic areas made telepsychiatry a logical initial target for these discussions. After reviewing the use of telemedicine in South Carolina and other States, the partners collectively decided to create and implement a telepsychiatry program in hospital EDs.

Securing of funding for demonstration project : In 2007, program leaders contacted the Duke Endowment (a non-profit foundation that supports innovative health care programs) for funding a demonstration project. In 2008, the Duke Endowment agreed to provide a $3.7 million, 3-year grant for this purpose.

Project planning : Four hospitals agreed to participate in the demonstration project, which launched in March 2009. In advance of this date, the partners and participating hospitals worked together to hire and train six psychiatrists, install and test the video equipment in EDs, and set up an EMR system linking the psychiatrists with the EDs.

Program expansion : After the demonstration project went smoothly, program leaders decided in June 2009 to expand the program to three additional sites and have continued to add more sites gradually since that time. From March 2009 through August 2014, more than 20,000 telepsychiatry ED consults have taken place. As of August 2014, 20 hospitals participate, with plans to add 6 more in 2014.

Standardization of training : As the initiative expanded, program leaders standardized the training process for psychiatrists and ED staff, as outlined below:

Psychiatrist training : Participating psychiatrists complete 6ăh of clinical training by viewing videos prepared by University of South Carolina School of Medicine faculty. Supplemented with handouts, the videos cover child and adolescent psychiatry, adult psychiatry, geriatric psychiatry, addiction psychiatry, risk assessment, and legal issues. Newly hired psychiatrists also undergo peer review every 2ăweeks during their first 3ămonths of employment. In addition, during this initial 3-month period, the supervising psychiatrist meets with other hospital physicians to review and discuss consultations performed by newly hired psychiatrists.

ED staff training : ED staffs in participating hospitals watch a video that explains the videoconferencing system and reviews the goals of the program and the training and credentials of the participating psychiatrists. A member of the project leadership team visits each participating ED to discuss questions or concerns that staff might have about the program.

Ongoing meetings to resolve problems, plan expansion : Representatives of the partnering organizations and the participating hospitals meet on a quarterly basis to share program-related experiences, resolve any issues or problems that arise, and discuss and plan for expansion to other EDs. Typically, hospital administrators, providers, researchers, and information technology staff come to these meetings; representatives of non-participating hospitals are also welcome to attend to learn more about the program.

Resources Used and Skills Needed

Staffing : Six full-time psychiatrists and one part-time psychiatrist staff the program, under the supervision of a lead psychiatrist. The program includes several stakeholders namely a director, coordinator, fiscal technician, programmer, and two information resource consultants (subject matter experts; SMEs). Faculty and staff members from the University of South Carolina and Emory University, staff members from the Department of Mental Health and from the South Carolina Office of Research and Statistics also provide support to the program.

Costs : Hard data on the program’s total annual cost are not available. Major program expenses consist of staff salaries and the upfront and ongoing expenses associated with the videoconferencing and EMR technologies.

Keywords: PCORI, PMBOK, PMI, clinical research, code of ethics, professional conduct, project stakeholder management

Citation: Pandi-Perumal SR, Akhter S, Zizi F, Jean-Louis G, Ramasubramanian C, Edward Freeman R and Narasimhan M (2015) Project stakeholder management in the clinical research environment: how to do it right. Front. Psychiatry 6:71. doi: 10.3389/fpsyt.2015.00071

Received: 14 December 2014; Accepted: 27 April 2015; Published: 18 May 2015

Reviewed by:

Copyright: © 2015 Pandi-Perumal, Akhter, Zizi, Jean-Louis, Ramasubramanian, Edward Freeman and Narasimhan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Seithikurippu R. Pandi-Perumal, Department of Population Health, Division of Health and Behavior, New York University Medical Center, Center for Healthful Behavior Change (CHBC), Clinical and Translational Research Institute, 227 East 30th Street (between 2nd and 3rd Avenue), Floor # 6 – 632E, New York, NY 10016, USA, pandiperumal2015@gmail.com

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

TILTomorrow today: dynamic factors predicting changes in intracranial pressure treatment intensity after traumatic brain injury

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Practices for controlling intracranial pressure (ICP) in traumatic brain injury (TBI) patients admitted to the intensive care unit (ICU) vary considerably between centres. To help understand the rational basis for such variance in care, this study aims to identify the patient-level predictors of changes in ICP management. We extracted all heterogeneous data (2,008 pre-ICU and ICU variables) collected from a prospective cohort (<em>n</em>=844, 51 ICUs) of ICP-monitored TBI patients in the Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI) study. We developed the TILTomorrow modelling strategy, which leverages recurrent neural networks to map a token-embedded time series representation of all variables (including missing values) to an ordinal, dynamic prediction of the following day's five-category therapy intensity level (TIL (Basic) ) score. With 20 repeats of 5-fold cross-validation, we trained TILTomorrow on different variable sets and applied the TimeSHAP (temporal extension of SHapley Additive exPlanations) algorithm to estimate variable contributions towards predictions of next-day changes in TIL (Basic) . Based on Somers' Dxy, the full range of variables explained 68% (95% CI: 65–72%) of the ordinal variation in next-day changes in TIL (Basic) on day one and up to 51% (95% CI: 45–56%) thereafter, when changes in TIL (Basic) became less frequent. Up to 81% (95% CI: 78–85%) of this explanation could be derived from non-treatment variables (i.e., markers of pathophysiology and injury severity), but the prior trajectory of ICU management significantly improved prediction of future de-escalations in ICP-targeted treatment. Whilst there was no significant difference in the predictive discriminability (i.e., area under receiver operating characteristic curve [AUC]) between next-day escalations (0.80 [95% CI: 0.77–0.84]) and de-escalations (0.79 [95% CI: 0.76–0.82]) in TIL (Basic) after day two, we found specific predictor effects to be more robust with de-escalations. The most important predictors of day-to-day changes in ICP management included preceding treatments, age, space-occupying lesions, ICP, metabolic derangements, and neurological function. Serial protein biomarkers were also important and may serve a useful role in the clinical armamentarium for assessing therapeutic needs. Approximately half of the ordinal variation in day-to-day changes in TIL (Basic) after day two remained unexplained, underscoring the significant contribution of unmeasured factors or clinicians' personal preferences in ICP treatment. At the same time, specific dynamic markers of pathophysiology associated strongly with changes in treatment intensity and, upon mechanistic investigation, may improve the timing and personalised targeting of future care.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Protocols

https://www.clinicaltrials.gov/study/NCT02210221

Funding Statement

This research was supported by the National Institute for Health Research (NIHR) Brain Injury MedTech Co-operative. CENTER-TBI was supported by the European Union 7th Framework programme (EC grant 602150). Additional funding was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA), from Integra LifeSciences Corporation (USA), and from NeuroTrauma Sciences (USA). CENTER-TBI also acknowledges interactions and support from the International Initiative for TBI Research (InTBIR) investigators. S.B. is funded by a Gates Cambridge Scholarship. E.B. is funded by the Medical Research Council (MR N013433-1) and by a Gates Cambridge Scholarship. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The list of sites, ethical committees, approval numbers, and approval dates can be found online: https://www.center-tbi.eu/project/ethical-approval. Ethikkommission der Medizinischen Universitat Wien of Medizinische Universitat Wien Universitatsklinik fur Unfallchirurgie gave ethical approval for this work; Ethikkommission der Medizinischen Universitat Innsbruck of Medizinische Universitat Innsbruck Universitatsklinik fur Neurologie gave ethical approval for this work; Centraal Ethisch Comite, Ethisch Comite Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen of Antwerp University Hospital gave ethical approval for this work; Centraal Ethisch Comite, Ethisch Comite Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen Comite d'Ethique 412 of CHR Citadelle gave ethical approval for this work; Centraal Ethisch Comite, Ethisch Comite Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen Comite d'Ethique hospitalo-facultaire niversitaire de Liege (707) of CHU gave ethical approval for this work; Centraal Ethisch Comite, Ethisch Comite Universitair Ziekenhuis Antwerpen en de Universiteit Antwerpen Comissie Medische Ethiek UZ KU Leuven / Onderzoek of UZ Leuven gave ethical approval for this work; De Videnskabsetiske Komiteer for Region Syddanmark of Odense Universiteitshospital, Neurokirurgisk afdeling gave ethical approval for this work; De Videnskabsetiske Komiteer for Region Syddanmark of Region Hovedstaden Rigshopitalet gave ethical approval for this work; Varsinais suomen sairaanhoitopiirin kuntayhtyma, Eettinen Toimikunta of Turku University Hospital gave ethical approval for this work; Varsinais suomen sairaanhoitopiirin kuntayhtyma, Eettinen Toimikunta of Helsinki University Central Hospital gave ethical approval for this work; Agence Nationale de Securite du Medicament et des Produits de Sante ANSM of APHP gave ethical approval for this work; Agence Nationale de Securite du Medicament et des Produits de Sante ANSM of CHRU de Besancon gave ethical approval for this work; Agence Nationale de Securite du Medicament et des Produits de Sante ANSM of Lille University Hospital gave ethical approval for this work; Agence Nationale de Securite du Medicament et des Produits de Sante ANSM of University Hospital of Grenoble gave ethical approval for this work; Agence Nationale de Securite du Medicament et des Produits de Sante ANSM of University Hospital Nancy gave ethical approval for this work; Agence Nationale de Securite du Medicament et des Produits de Sante ANSM of CHU Poitiers gave ethical approval for this work; Ethikkommission Medizinsche Fakultat Heidelberg of Universitatsklinikum Heidelberg Neurochirurgische Kliniki gave ethical approval for this work; Ethikkommission an der Medizinsche Fakultat Der rheinsch-Westfalischen Technischen Hocgschule Aachen of Charite | Campus Virchow Klinikum gave ethical approval for this work; Ethikkommission an der Medizinsche Fakultat Der rheinsch-Westfalischen Technischen Hocgschule Aachen of Uniklinik RWTH Aachen gave ethical approval for this work; Ethikkommission Medizinsche Fakultat Heidelberg of Klinikum Ludwigsburg gave ethical approval for this work; ETT TUKEB Egeszsegugyi Tudomanyos Tanacs Pecsi Tudomanyegyetem of Pecsi Tudomanyegyetem Klinikai Kozpont gave ethical approval for this work; ETT TUKEB Egeszsegugyi Tudomanyos Tanacs Szegedi Tudomanyegyetem of zegedi tudomanyegyetem orvostudomanyi kar Szent Gyorgyi Albert Klinikai Kozpont gave ethical approval for this work; Helsinki Committee, Rambam Health Care Campus of Rambam Medical Center gave ethical approval for this work; Hadassah Medical Organization IRB of Hadassah-hebrew University Medical Center gave ethical approval for this work; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Direzione Scientifica Comitato Etico of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico gave ethical approval for this work; Comitato Etico, Ospedale San Raffaele of Ospedale San Raffaele gave ethical approval for this work; Comitato Etico Interaziendale A.O.U. Citta della Salute e della Scienza di Torino, A.O. Ordine Mauriziano, A.S.L. of AOU Citta della Salute e della Scienza di Torino gave ethical approval for this work; Comitato Etico IRST IRCCS AVR of Bufalini Hospital gave ethical approval for this work; Comitato Etico, Ospedale San Raffaele of Azienda Ospedaliera Universita di Padova gave ethical approval for this work; Comitato Etico Della Provincia Monza Brianza of San Gerardo Hospital/ASST gave ethical approval for this work; Comitato Etico Interaziendale A.O.U. 'Maggiore della Carita' of Maggiore Della Carita Hospital gave ethical approval for this work; Comitato Etico, Ospedale Niguarda Ca' Granda of Niguarda Hospital gave ethical approval for this work; Ethics Commiitee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society of Pauls Stradins Clinical University Hospital gave ethical approval for this work; Ethics Commiitee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society of Riga Eastern Clinical University Hospital gave ethical approval for this work; Ethics Commiitee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society of Rezekne Hospital gave ethical approval for this work; VILNIAUS REGIONINIS BIOMEDICININIU TYRIMU ETIKOS KOMITETAS of Vilniaus Universiteto Ligonine gave ethical approval for this work; KAUNO REGIONINIS BIOMEDICININIU TYRIMU ETIKOS KOMITETAS of LSMUL Kauno klinikos Skubio pagalbos skyrius gave ethical approval for this work; Leids Universitair Centrum, Commissie Medische Ethiek of Het Leids Universitair Medisch Centrum te Leiden gave ethical approval for this work; Leids Universitair Centrum, Commissie Medische Ethiek of Erasmus MC gave ethical approval for this work; Leids Universitair Centrum, Commissie Medische Ethiek of Medisch Centrum Haaglanden gave ethical approval for this work; Leids Universitair Centrum, Commissie Medische Ethiek of Het Haga Hospital gave ethical approval for this work; Leids Universitair Centrum, Commissie Medische Ethiek of Radboud UMC gave ethical approval for this work; Leids Universitair Centrum, Commissie Medische Ethiek of St. Elisabeth Ziekenhuis gave ethical approval for this work; Leids Universitair Centrum, Commissie Medische Ethiek of UMC Groningen gave ethical approval for this work; Regional komite for medisinsk og helsefaglig forskningsetikk REK midt-Norge (REK midt) of Universitetssykehuset Nord-Norge gave ethical approval for this work; Regional komite for medisinsk og helsefaglig forskningsetikk REK midt-Norge (REK midt) of St.Olavs Hospital gave ethical approval for this work; Regional komite for medisinsk og helsefaglig forskningsetikk REK midt-Norge (REK midt) of Oslo Universitetssykehus gave ethical approval for this work; Comitetului de Etica a Spitalului Clinic Judeteam de Urgenta Timisoara of Clinica de Neurochirurgie Universitatea de Medicina si Farmacie Victor Babes Timisoara gave ethical approval for this work; Etidkog odbora Klinidkog centra Vojvodine of Klinidkog centra Vojvodine gave ethical approval for this work; Comite Etico de Investigacion Clinica del Hospital Universitario 12 de Octubre of Hospital Universitario 12 de Octubre gave ethical approval for this work; Comite etico de investigacion clinica y comision de proyectos de investigacion del hospital universitari Vall d'Hebron of Vall d'Hebron University Hospital gave ethical approval for this work; Comite Etico de Investigacion Clinica de Euskadi of Clinico Universitario de Cruces gave ethical approval for this work; Comite Etico de Investigacion Clinica del Clinico Universitario de Valencia of Clinico Universitario de Valencia gave ethical approval for this work; EPN (Regionala Etikprovningsnamnden i Stockholm) of Karolinksa University Hospital gave ethical approval for this work; EPN (Regionala Etikprovningsnamnden i Stockholm) of Umea University Hosptital gave ethical approval for this work; La Commission cantonale (VD) d'ethique de la recherche sur l'etre humain (CER-VD) of Centre hospitalier universitaire Vaudois gave ethical approval for this work; NHS HRA, UHB Research Governance Office, Queen Elizabeth Hospital of Queen Elizabeth Hospital gave ethical approval for this work; NHS HRA, Research and Development Department, Cambridge University Hospital NHS Foundation Trust of Cambridge University Hospital NHS Foundation Trust gave ethical approval for this work; NHS HRA, Research Governance Office, University Hospitals Southhampton NHS Trust of University Hospitals Southhampton NHS Trust gave ethical approval for this work; NHS HRA, Research and Development Department -Sheffield Teaching Hospitals NHS Foundation Trust of Sheffield Teaching Hospitals NHS Foundation Trust gave ethical approval for this work; NHS HRA, Research & Innovation Office, Kings college London NHS Foundation Trust of Kings college London gave ethical approval for this work; NHS HRA, Research and Development Department -Salford Royal Hospital NHS Foundation Trust of Salford Royal Hospital gave ethical approval for this work; NHS HRA, Research & Innovation Office, The Walton centre NHS Foundation Trust of The Walton centre NHS Foundation Trust gave ethical approval for this work; NHS HRA, Research & Innovation, North Bristol NHS Trust of Southmead Hospital Bristol gave ethical approval for this work; NHS Scotland, Research and Development Department, University Hospitals Division NHS Lothian of Lothian Health Board gave ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Data Availability

Individual participant data, including data dictionary, the study protocol, and analysis scripts are available online, conditional to approved study proposal, with no end date. Interested investigators must submit a study proposal to the management committee at https://www.center-tbi.eu/data. Signed confirmation of a data access agreement is required, and all access must comply with regulatory restrictions imposed on the original study. All code used in this project can be found at the following online repository: https://github.com/sbhattacharyay/TILTomorrow (DOI: 10.5281/zenodo.11060742).

https://www.center-tbi.eu/data

https://github.com/sbhattacharyay/TILTomorrow

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