documentation in research sample

Good Clinical Practice Study Documentation

The Department of Medicine Clinical Research Unit has prepared this document is to provide guidance to all faculty and staff involved in the conduct of research on the  best practices related to documentation .

Good study documentation will allow for an individual with basic knowledge of the particular project to recreate the events of the study.

General Information

• Maintain records of all data and observations pertinent to the research subject.  These records should be identifiable to a particular participant.
• Remember that source documents are where the information is first recorded.
• All data must be verifiable.
• Study documentation should be able to recreate the study for any reviewer.
• Attributable – Can you tell who wrote and/or did this
• Legible – Can it be read?
• Contemporaneous- – Is the data current, and in the correct time frame?  The notation, signature and date should occur at the same time.
• Original – Has the data been altered?
• Accurate – Are there conflicting data elsewhere?  Content should precisely reflect the event.
• Use a signed Note to File to explain any discrepancies, missing or incomplete data.
• The same standards maintained for medical documentation should be followed for research documentation
• All documents require 2 identifiers on each page. 
• All entries are to be signed and dated in real time.
• Error corrections are made by drawing a single line through the incorrect entry, initial and date.
• Never obliterate entries that require correction.
• Subject records need to be secure but accessible.
• Do not alter past-dated notes by writing alongside or adding to prior entries.  Updates may be made through addenda.
• Use dark ink, do not use pencil.
• Never use whiteout.
• If the source data is incomplete or deficient, it may be completed or corrected using an addendum.  This late entry must be signed and dated at the time it is created.

Note to File

• May be used to correct errors, or as an explanation to a departure from the protocol.  Reasons for any departure should be documented and attempts to correct or prevent in the future should be included.
• This should not be used as a panacea to correct any error.

Informed Consent

• The process requires documentation and should reflect the process approved by the IRB in a narrative form or through the use of a checklist.
• Signature and date and time must be of the person obtaining the consent, at the time of the process. (Not added later)

Case Report Forms as Source

Case report forms may be used as source only when this practice is clearly outlined in the protocol, and they represent the data collected for the research are where the data were initially recorded.   

Medical Records From Outside Source

• Copies of records from an outside source may be used if they support endpoints, inclusion/exclusion criteria or adverse events.
• Attempts to obtain medical records should be recorded in the research chart.

Questionnaires

• Documentation must reflect who completed the questionnaire, in compliance with the protocol.
• For questionnaires completed by staff, a note should reflect how the information was obtained ie: direct interview with participant, phone call, chart abstraction.

Chapter 22 Appendix B: A Guide to Research and Documentation

Research documentation guidelines.

This appendix provides general guidelines for documenting researched information. See Chapter 7 "Researching" for more on the research process.

22.1 Choosing a Documentation Format

As a rule, your assignments requiring research will specify a documentation format. If you are free to use the style of your choice, you can choose any format you want as long as you are consistent, but you should know that certain disciplines tend to use specific documentation styles:

• business and social sciences: American Psychological Association (APA)
• natural and applied sciences: Council of Science Editors (CSE)
• humanities: Modern Language Association (MLA) or the Chicago Manual of Style (CMS)

For the purposes of this appendix, we will confine ourselves to the three documentation formats that will be the most common in your undergraduate courses: the style manuals from APA and MLA, as well as CMS. (Other formats are listed at the end of this appendix. Also, note this appendix explains the “Notes-Bibliography” system of CMS, used more often in history, the arts, and humanities, rather than the “Author-Date” system, used in the sciences and social sciences.)

These three systems of documentation have been refined over many generations so that academics can rely on certain standards of attribution when they cite each other’s work and when their work is cited. When you enter into an academic conversation in a given discipline, it’s imperative that you play by its rules. It’s true that popular, nonacademic forms of attribution exist. Making a link to another website in a blog or a Twitter post works quite well, but in an academic context, such a form of attribution is not sufficient. Of course it should go without saying that stealing someone else’s words or borrowing them without attribution, whether you do it casually on the web or in an academic context, is simply wrong.

22.2 Integrating Sources

Your goal within a research paper is to integrate other sources smoothly into your paper to support the points you are making. As long as you give proper credit, you can ethically reference anyone else’s work. You should not, however, create a paper that is made up of one reference after another without any of your input. You should also avoid using half-page or whole-page quotations. Make sure to write enough of your material so that your sources are integrated into your work rather than making up the bulk of your paper.

Think of yourself as a kind of museum docent or tour guide when you are integrating sources into your work. You’ll usually want to take some time to set up your use of a source by placing it in a proper context. That’s why in most cases, before you even launch into quotation, paraphrase, or summary, you will have probably already used what’s called a “signal phrase” that identifies the author of the source, and often the specific publication (whether web or print) from which it is taken. After your use of the source, you’ll need to follow up with analysis and commentary on how you think it fits into the larger context of your argument.

22.3 Quoting, Paraphrasing, and Summarizing

When you quote another writer’s exact words, you will have to identify the page number within the source where you found the quotation or the paragraph number if the source is taken from an online format or database that does not indicate the original print pagination. Note that only APA allows the use of “p.” or “pp.”

Table 22.1 Citing Quotations

Paraphrased and summarized text is cited within text in the same way that quoted material is cited except that quotations are not used. In APA style, you do not need to include page numbers in this case, but MLA and CMS, on the other hand, do still require page numbers, when they are available.

Table 22.2 Citing Paraphrased or Summarized Text

22.4 Formatting In-Text References

When you use others’ ideas, you have a variety of options for integrating these sources into your text. The main requirement is that you make it clear within your in-text reference that the information is not yours and that you clearly indicate where you got the idea. The following box shows some alternate phrases for signaling that the ideas you are using belong to another writer. Using a variety of wording makes writing more interesting. Note: Past tense is used in these examples. You may elect to use present tense (“writes”) or past perfect tense (“has written”), but keep your tense use consistent.

Phrases That Signal an Idea Belongs to Another Writer (Shown in APA style)

• According to Starr (2010)…
• Acknowledging that…
• Starr (2010) stated…
• As Starr (2010) noted…
• In 2010, Starr reported…
• In the words of Starr (2010)…
• It is obvious, according to Starr (2010), that…
• Starr (2010) argued that…
• Starr (2010) disagreed when she said…
• Starr (2010) emphasized the importance of…
• Starr (2010) suggested…
• Starr observed in 2010 that…
• Technology specialist, Linda Starr, claimed that…(2010).
• …indicated Starr (2010).
• …wrote Starr (2010)

Table 22.3 "Integrating Sources (Summarized or Paraphrased Ideas)" shows some actual examples of integrating sources within the guidelines of the three most common documentation formats. You should weave the cited details in with your ideas.

Table 22.3 Integrating Sources (Summarized or Paraphrased Ideas)

Table 22.4 Two Authors

Table 22.5 Multiple Authors

Table 22.6 Personal Communication

22.5 Developing a List of Sources

This appendix provides a general overview of some of the most common documentation guidelines for different types of sources. For situations not described in this appendix, such as types of sources not described in this chapter or situations where you elect to use footnotes or endnotes in addition to in-text, parenthetical citations, check the complete guidelines for the style you are using:

• APA: http://www.apastyle.org
• MLA: http://www.mla.org
• CMS: http://www.chicagomanualofstyle.org

Some general online searches, especially those conducted on your library databases, are also likely to generate guidelines for a variety of documentation styles. Look for an opportunity to click on a “citation” or “documentation” icon, or ask a member of your college library staff for guidance. You can even get help through the word processing program you typically use. Microsoft Word, for instance, has an entire tab on the taskbar devoted to managing and documenting sources in all three of the styles featured here. Also, don’t forget the tip from Chapter 7 "Researching" about the free resources that abound on the web from various online writing labs (OWLs) managed by writing programs at colleges and universities across the country.

Each different documentation style has its own set of guidelines for creating a list of references at the end of the essay (called “works cited” in MLA, “references” in APA, and “bibliography” in CMS). This section includes citations for the sources included in other parts of this appendix. For additional citation styles, consult complete citation guidelines for the style you are using.

Source lists should always be in alphabetical order by the first word of each reference, and you should use hanging indentation (with the first line of each reference flush with the margin and subsequent lines indented one-half inch). Here are some of the most common types of entries you will be using for your references at the end of your research essays. These lists are by no means exhaustive, but you will note from the examples some of the most important differences in conventions of punctuation, font, and the exact content of each style.

Table 22.7 APA References

Table 22.8 MLA Works Cited

Table 22.9 CMS Bibliography

22.6 Using Other Formats

Although APA, MLA, and Chicago are the most widely used documentation styles, many other styles are used in specific situations. Some of these other styles are listed in Table 22.10 "Other Documentation Formats" . You can find more about them by searching online.

Table 22.10 Other Documentation Formats

Documentation in Reports and Research Papers

• An Introduction to Punctuation
• Ph.D., Rhetoric and English, University of Georgia
• M.A., Modern English and American Literature, University of Leicester
• B.A., English, State University of New York

In a report or  research paper , documentation is the evidence  provided for information and ideas borrowed from others. That evidence includes both primary sources  and secondary sources .

There are numerous documentation styles and formats, including MLA style (used for research in the humanities), APA style (psychology, sociology, education), Chicago style (history), and ACS style (chemistry).

Examples and Observations

• Adrienne Escoe "Documentation has many meanings, from the broad—anything written in any medium—to the narrow—policies and procedures manuals or perhaps records." ( T he Practical Guide to People-Friendly Documentation , 2nd. ed. ASQ Quality Press, 2001)
• Kristin R. Woolever "An issue more important than documentation form is knowing when to document. In brief, anything that is copied needs to be documented... "Perhaps the best tip for knowing when to document is to use common sense. If writers are careful to give credit where it is due and to provide the reader with easy access to all the source material, the text is probably documented appropriately." ( About Writing: A Rhetoric for Advanced Writers . Wadsworth, 1991)

Note-Taking and Documentation During the Research Process

• Linda Smoak Schwartz "The most important thing to remember when you take notes from your sources is that you must clearly distinguish between quoted, paraphrased , and summarized material that must be documented in your paper and ideas that do not require documentation because they are considered general knowledge about that subject." ( The Wadsworth Guide to MLA Documentation , 2nd ed. Wadsworth, 2011)

Library Resources Versus Internet Resources

• Susan K. Miller-Cochran and Rochelle L. Rodrigo "When you are reviewing and analyzing your resources, keep in mind that the library/Internet distinction is not quite as simple as it might seem at first. The Internet is where students often turn when they are having difficulty getting started. Many instructors warn students against using Internet resources because they are easily alterable and because anyone can construct and publish a Web site. These points are important to remember, but it is essential to use clear evaluative criteria when you are looking at any resource. Print resources can be self-published as well. Analyzing how easily a resource is changed, how often it is changed, who changed it, who reviews it, and who is responsible for the content will help you choose resources that are reliable and credible, wherever you might find them." ( The Wadsworth Guide to Research, Documentation , rev. ed. Wadsworth, 2011)

Parenthetical Documentation

• Joseph F. Trimmer "You may decide to vary the pattern of documentation by presenting the information from a source and placing the author's name and page number in parentheses at the end of the sentence. This method is particularly useful if you have already established the identity of your source in a previous sentence and now want to develop the author's idea in some detail without having to clutter your sentences with constant references to his or her name.​" ( A Guide to MLA Documentation , 9th ed. Wadsworth, 2012)
• What Is a Style Guide and Which One Do You Need?
• Bibliography: Definition and Examples
• Definition of Appendix in a Book or Written Work
• Characteristics of a Formal Prose Style
• What Is a Research Paper?
• Primary and Secondary Sources in History
• Thesis: Definition and Examples in Composition
• What Is a Primary Source?
• Justification (Typesetting and Composition)
• How to Use Footnotes in Research Papers
• An Introduction to Academic Writing
• Biographies: The Stories of Humanity
• Margin (Composition Format) Definition
• Holistic Grading (Composition)
• Definition and Examples of Evidence in Argument
• How to Use Block Quotations in Writing

Sample Papers

This page contains sample papers formatted in seventh edition APA Style. The sample papers show the format that authors should use to submit a manuscript for publication in a professional journal and that students should use to submit a paper to an instructor for a course assignment. You can download the Word files to use as templates and edit them as needed for the purposes of your own papers.

Most guidelines in the Publication Manual apply to both professional manuscripts and student papers. However, there are specific guidelines for professional papers versus student papers, including professional and student title page formats. All authors should check with the person or entity to whom they are submitting their paper (e.g., publisher or instructor) for guidelines that are different from or in addition to those specified by APA Style.

Sample papers from the Publication Manual

The following two sample papers were published in annotated form in the Publication Manual and are reproduced here as PDFs for your ease of use. The annotations draw attention to content and formatting and provide the relevant sections of the Publication Manual (7th ed.) to consult for more information.

• Student sample paper with annotations (PDF, 5MB)
• Professional sample paper with annotations (PDF, 2.7MB)

We also offer these sample papers in Microsoft Word (.docx) format with the annotations as comments to the text.

• Student sample paper with annotations as comments (DOCX, 42KB)
• Professional sample paper with annotations as comments (DOCX, 103KB)

Finally, we offer these sample papers in Microsoft Word (.docx) format without the annotations.

• Student sample paper without annotations (DOCX, 36KB)
• Professional sample paper without annotations (DOCX, 96KB)

Sample professional paper templates by paper type

These sample papers demonstrate APA Style formatting standards for different professional paper types. Professional papers can contain many different elements depending on the nature of the work. Authors seeking publication should refer to the journal’s instructions for authors or manuscript submission guidelines for specific requirements and/or sections to include.

• Literature review professional paper template (DOCX, 47KB)
• Mixed methods professional paper template (DOCX, 68KB)
• Qualitative professional paper template (DOCX, 72KB)
• Quantitative professional paper template (DOCX, 77KB)
• Review professional paper template (DOCX, 112KB)

Sample papers are covered in the seventh edition APA Style manuals in the Publication Manual Chapter 2 and the Concise Guide Chapter 1

Related handouts

• Heading Levels Template: Student Paper (PDF, 257KB)
• Heading Levels Template: Professional Paper (PDF, 213KB)

Other instructional aids

• Journal Article Reporting Standards (JARS)
• APA Style Tutorials and Webinars
• Handouts and Guides
• Paper Format

View all instructional aids

Sample student paper templates by paper type

These sample papers demonstrate APA Style formatting standards for different student paper types. Students may write the same types of papers as professional authors (e.g., quantitative studies, literature reviews) or other types of papers for course assignments (e.g., reaction or response papers, discussion posts), dissertations, and theses.

APA does not set formal requirements for the nature or contents of an APA Style student paper. Students should follow the guidelines and requirements of their instructor, department, and/or institution when writing papers. For instance, an abstract and keywords are not required for APA Style student papers, although an instructor may request them in student papers that are longer or more complex. Specific questions about a paper being written for a course assignment should be directed to the instructor or institution assigning the paper.

• Discussion post student paper template (DOCX, 31KB)
• Literature review student paper template (DOCX, 37KB)
• Quantitative study student paper template (DOCX, 53KB)

Sample papers in real life

Although published articles differ in format from manuscripts submitted for publication or student papers (e.g., different line spacing, font, margins, and column format), articles published in APA journals provide excellent demonstrations of APA Style in action.

APA journals began publishing papers in seventh edition APA Style in 2020. Professional authors should check the author submission guidelines for the journal to which they want to submit their paper for any journal-specific style requirements.

Credits for sample professional paper templates

Quantitative professional paper template: Adapted from “Fake News, Fast and Slow: Deliberation Reduces Belief in False (but Not True) News Headlines,” by B. Bago, D. G. Rand, and G. Pennycook, 2020, Journal of Experimental Psychology: General , 149 (8), pp. 1608–1613 ( https://doi.org/10.1037/xge0000729 ). Copyright 2020 by the American Psychological Association.

Qualitative professional paper template: Adapted from “‘My Smartphone Is an Extension of Myself’: A Holistic Qualitative Exploration of the Impact of Using a Smartphone,” by L. J. Harkin and D. Kuss, 2020, Psychology of Popular Media , 10 (1), pp. 28–38 ( https://doi.org/10.1037/ppm0000278 ). Copyright 2020 by the American Psychological Association.

Mixed methods professional paper template: Adapted from “‘I Am a Change Agent’: A Mixed Methods Analysis of Students’ Social Justice Value Orientation in an Undergraduate Community Psychology Course,” by D. X. Henderson, A. T. Majors, and M. Wright, 2019,  Scholarship of Teaching and Learning in Psychology , 7 (1), 68–80. ( https://doi.org/10.1037/stl0000171 ). Copyright 2019 by the American Psychological Association.

Literature review professional paper template: Adapted from “Rethinking Emotions in the Context of Infants’ Prosocial Behavior: The Role of Interest and Positive Emotions,” by S. I. Hammond and J. K. Drummond, 2019, Developmental Psychology , 55 (9), pp. 1882–1888 ( https://doi.org/10.1037/dev0000685 ). Copyright 2019 by the American Psychological Association.

Review professional paper template: Adapted from “Joining the Conversation: Teaching Students to Think and Communicate Like Scholars,” by E. L. Parks, 2022, Scholarship of Teaching and Learning in Psychology , 8 (1), pp. 70–78 ( https://doi.org/10.1037/stl0000193 ). Copyright 2020 by the American Psychological Association.

Credits for sample student paper templates

These papers came from real students who gave their permission to have them edited and posted by APA.

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How to write good documentation: home, documentation.

Why to Write Documentation

Documentation effectively connects humans and machines.

Why writing documentation is important:

• You will be using your code in 6 months
• You want people to use your code and give you credit
• You want to learn self-determination
• Others would be encouraged to contribute to your code
• Others can easily use your code and build upon it
• Advance the science
• Encourage open science 
• Allow reproducibility and transparency

What should you document about your research? Everything! All the data, notes, code, and materials someone else would need to reproduce your work.

Consider the following questions:

• How is your data gathered?
• What variables did you use?
• Did you use any code to clean/analyze your data?

Best Practices for Documenting Your Project

Best Practices for Writing Documentation:

• A brief description of the project
• Installation instructions
• A short example/tutorial
• Allow issue tracker for others
• What a function does
• What are the function's parameters or arguments are
• What a function returns
• Document your code
• Apply coding conventions, such as file organization, comments, naming conventions, programming practices, etc.
• Include information for contributors
• Include citation information
• Include licensing information
• Link to your e-mail address at the end
• List all the versions of the files along with the major edits you did in each version

An important tip: Naming files should be descriptive and consistent!

• Date format (ISO 8601 Standard): YYYYMMDDThhmmss
• Project or experiment name
• Researcher name/initials
• Date or date range of collection version

An example for README file.

An example of code documentation.

Tools for Documentation

Tools for Documentation:

• Doctest  
• R Markdown  
• Doxygen  - Doxygen can be used for C, C#, PHP, Java, Python, and Fortran.
• ​ BoostBook

Software Documentation Hosting Options:

• Read The Docs
• 18 Software Documentation Tools
• BIDS Docathon Kickoff - A Video
• Docathon at BIDS
• Documenting Your Code
• First Steps with Sphinx
• Google Style Guides
• How to maintain an open source project
• A Quick Guide to Software Licensing for the Scientist-Programmer

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• Last Updated: Nov 6, 2023 2:10 PM
• URL: https://guides.lib.berkeley.edu/how-to-write-good-documentation

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OpenScience blog

Documenting your research data along the way: tips and tools.

By Hilde van Zeeland

It happens all too often: researchers fail to use data collected by themselves or by others due to a lack of documentation. Documentation refers to information about your research data. It is meant to make your data understandable – to others who might want to reuse it, but also to your future self. Wageningen University & Research Library provides courses and advice on data documentation. In this blog post, we discuss what to document, and give tips & tools for documenting throughout the research process.

What to document?

In short, you should document all information needed to understand your data. Think of:

• General project information: title of the study, people involved and their roles, etc.
• Methodological information: methods of data collection and analysis, instrument calibrations, etc.
• Data-specific information: variable names and definitions, units of measurement, etc.

Documentation is often added to a dataset in a separate README.txt file. This page gives more information on README-files including a template you can use.

How do I document?

The trick to good documentation is to start long before you create the README-file – it’s best to document your data throughout your research. If you wait until the end, chances are that you will no longer remember what variable P2_scomF stands for, or how you got to the figures in a certain column.

A few tips for continuous documentation:

• Try a generic tool like OneNote for keeping and organising notes. You can structure these notebooks to your own research. Once you have finished your research, you can easily select the notes you wish to add to your dataset (e.g. as a README-file).
• Use an electronic lab notebook for structured documenting. Your group might have a shared e-lab notebook tool you can use. One example is eLabJournal .
• If you use a proprietary software such as OneNote or a e-lab notebook, make sure to export or convert your documentation to an open file format when you make it available to others. This way, people do not need the original software to open the files – and the files will remain readable even if the software becomes obsolete.
• Do you work with spreadsheets? The free tool Colectica for Excel allows you to add documentation to your spreadsheets. Think of the explanation of variables and code lists. You can also export these to create separate documentation files.
• If you work with scripting languages, such as R or Python, take a look at Jupyter Notebook . With this free, web-based tool you create one single document showing code snippets and their results in place. This provides a step-by-step overview of your data processing and analysis. Find examples of Jupyter notebooks by research domain here . This page also provides a list of journal articles with documentation in Jupyter notebooks.

Put it to the test!

How do you know if your final documentation is understandable to others? Put it to the test! Simply give your dataset with documentation to somebody else. If this person has trouble understanding your data, there’s room for improvement. Of course you can always contact Data Management Support if you need help.

Good luck documenting your data!

Join the new Research Data Management group on Intranet for more tips & tricks, events, and other data info.

Related posts:

• Create more impact: dare to share your research data
• 10 Tweets on The Making of… Research Data Management Policy
• Wageningen Economic Research: secure data storing and sharing
• Data Management Plan Requirements of Public Funding Agencies

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Principles of Documenting Data

In this lesson you will learn, initial questions, documentation overview.

When to Document Data

Levels of Documentation

Project level documentation, file level documentation, documenting your data, sample solution.

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Good documentation practice in clinical research

Chitra bargaje.

Department of Clinical Trials and Safety, Global Quality and Regulatory Compliance, Bristol Myers Squibb, Mumbai, India

One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement.

INTRODUCTION

Inadequate/inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites.

Similarly, source documentation issues ranked 5th among the top 10 findings from European Medicines Agency (EMA) inspections of investigator sites in 2009[ 1 ] and in some instances the findings were classified ‘critical’. Not surprisingly, clinical trial monitors and auditors also report documentation issues as a frequent area of GCP concern.

I would like to share an experience at a recent investigator site audit.

During the audit opening meeting we were informed that all the source data is on paper and no electronic documentation is used. The site was actually using MS word to document the data collected during the study. In normal practice the site did not use MS word to generate medical records. This method was adopted only for clinical trial subjects. For the trial subjects there were no other hand-written progress notes which the site would normally use for routine patients.

There were two underlying potential issues here:

• First, the site was following a different practice for documenting progress for clinical research subjects. Were the subjects’ records missing any elements of standard care because of the deviation from routine practice?
• Second, the site thought they had no electronic documentation, although MS word was used to record all subject data.

This example, illustrates a common occurrence in clinical trial research where a lack of understanding of basic GCP principles may have a negative impact on the quality of the study.

WHAT IS THE PURPOSE OF SOURCE DOCUMENTATION?

To understand the importance of good source documentation we should first review the purpose of source documentation. The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide audit trail to permit investigation if and when required.

Source documentation is the medical record of the subject before, during and after the trial.

It is the tool which confirms the eligibility criteria of the subject in the given trial.

It documents the progress of the subject from consenting till the subject completes the study. It records the accountability of the investigational product dispensed, consumed and returned by the subject. It serves as the complete medical record of the subject as the reference to the treating physician at any point of time.

Finally it forms a strong foundation for the data that gets transcribed into a CRF which ultimately gets translated into a clinical study report.

Irrespective of clinical trial, accurate documentation supports the fundamental principle of protecting subject’s rights, safety and well-being.

There can not be two thoughts to emphasize the need for reliable and quality documentation.

PRINCIPLES OF GOOD DOCUMENTATION PRACTICE

So, what does it mean when we say ‘Good Documentation’ and how do we practice it?

Any basic training in clinical research will definitely include these phrases:

‘What is not documented is not done!’

‘Document what is done as well as what is not done!’

Roots of good documentation principles are in the ICH-GCP where source data and source document is first defined.

ICH E6 1.51 source data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

The words in italics describe some inherent qualities of source data.

ICH E6 1.52 source documents

Original documents, data and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, X-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

This definition describes the various types of documents which collectively form the source document.

Key attributes for good documentation were first described by US-FDA in the form of ALCOA -attributable, legible, contemporaneous, original and accurate. These are also adapted by World Health Organization (WHO). These criteria evolved with time. EMA has added some more ‘letters’ to describe qualities of good source documentation particularly for electronic documentation.[ 2 – 4 ]

Let‘s look at these attributes described by different authorities collectively.

Attributable

It should be clear who has documented the data.

Readable and signatures identifiable.

Contemporaneous

The information should be documented in the correct time frame along with the flow of events. If a clinical observation cannot be entered when made, chronology should be recorded. Acceptable amount of delay should be defined and justified.[ 4 ]

Original, if not original should be exact copy; the first record made by the appropriate person. The investigator should have the original source document.

Accurate, consistent and real representation of facts.

Long-lasting and durable.

Available and accessible

Easily available for review of treating physicians and during audits/inspections. The documents should be retrievable in reasonable time.

Complete till that point in time.

Demonstrate the required attributes consistently.

Based on real and reliable facts.

Corroborated

The data should be backed up by evidence.

Interestingly, it should be noted that the Drug Controller General India (DCGI) would emphasize on the condition in addition to the completeness, legibility and accessibility of investigator source data file as noted in DCGI’s guidance document for inspections.[ 5 ] My understanding of ‘condition’ is the state of the source documents, in terms of filing, storing and readability.

The degree to which the data fulfills the data quality criteria establishes acceptability of the data. It also determines the degree of excellence of the data quality. Qualities like consistency, credibility and corroboration help establish data integrity along with the data quality.

These are the expectations from clinical trial documentation however in reality many issues are observed in terms of quality of source documentation.

COMMON FINDINGS WITH RESPECT TO SOURCE DOCUMENTATION

‘Failure to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation’ is cited in 6 out of the 10 warning letters issued by US-FDA to clinical investigators in 2010.[ 6 ]

At one investigator site source documents were not available because the computer ‘crashed’ . So in the absence of availability, adequacy of the records could not be evaluated. The investigator was warned for ‘failure to retain records required to be maintained for the required timeframe per regulations’ .

I would like to highlight some of the findings from the warning letters in detail here. These findings give an idea of regulatory expectations and lacunae in documentation noted during inspections. I am sure readers would be able to relate to some of these findings with their personal experience.

• Eligibility criteria could not be confirmed. For e.g., (a)IVRS user manual states “Complete call worksheets prior to contacting the IVRS; then file completed worksheets with each subject’s source documentation.” The IVRS worksheets were not kept in the subjects’ files or maintained at the site and as such it could not be confirmed that patients were stratified in the right arm and received the medication they were assigned to. (b) All the items in the exclusion criteria checklist are checked except for the exclusion criterion related to the history of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count <100,000 cells/microliter. In the absence of lab report this exclusion criteria could not be confirmed on the basis of the incomplete checklists.
• Multiple records for same data points making it unable to determine which served as the accurate source record, for e.g., multiple versions of visual analog scales completed for same visit with different values.
• Discrepancies in records to confirm primary efficacy endpoint of the study, for e.g., the total administered dose of morphine, as reflected in hospital records was different from the Case Report Form. The primary efficacy endpoint of the protocol was to measure the reduction in the requirement for morphine use in the 24 hours following surgery measured by total morphine usage compared to placebo.
• Clinical significance for out of range lab values not documented on the lab reports or conflicting information found in the source documentation-e.g., significant high glucose value marked as clinically nonsignificant on the lab report although the subject was referred to for primary physician for further follow-up.
• Missing pages from subject interview scales, numerous unexplained corrections months after the initial entries and conflicting information; incorrect subject identifiers, incorrect date e.g., same date on screening visit, visit week 1 and week 4.
• Numerous AEs not reported in CRFs, delays in transcribing data in CRFs, discrepancies between source and the CRF. Lack of timely reporting of AEs in eCRFs jeopardizes subject safety and reliability and integrity of data captured at the site.
• Incorrect/incomplete documentation regarding the disposition of drugs-dates, quantity and use by subjects.

Although some of these issues may appear minor prima facie such as some checkboxes not checked, a lab report not marked for significance for out of range value, some discrepancies in source and CRF, unexplained corrections, these issues point toward lack of understanding of good documentation requirements. For an independent observer such data would fail to provide confidence and assurance of data quality and safety of the subjects enrolled. The data may be deemed unfit for use. All exposure of patients to new drugs and the efforts and time spent by the investigator team would be wasted.

Systematic deficiencies in documentation can lead to questions about the integrity of the data, potentially resulting in health authority decisions to exclude the data from analysis.

In essence, we can definitely say that the quality of documentation can make or break the study at a given site.

WHAT ARE THE POSSIBLE ROOT CAUSES FOR REPEATED DEFICIENCIES IN SOURCE DOCUMENTATION?

Clinical research documentation involves a variety of documents from various sources and is often completed by several people. Thus rendering this process to be complicated and posing challenges to meet requirements. Moreover clinical research happens over a long period of time which adds to the challenge of maintaining continuity in the documentation practice.

Inadequacies in documentation could be the result of lack of training and experience in good understanding of clinical research and documentation requirements. As a result the principal investigator (PI) and staff may continue documentation per the routine medical practice. In India, the documentation in routine medical practice may not be as extensive as what would be expected for clinical research.

Additional unmonitored medical records are discovered at the time of audits/inspections. Such as: Diaries of coordinator, inpatient records of the hospital, electronic records, etc., for the simple reason that the staff does not realize that these form a part of source record. These unmonitored records may have important data which do not find its way to the CRF. This would have an impact on the availability of important information in CRFs. Reliability and integrity of data might me affected as a result.

In many FDA warning letters one can observe that inadequate case histories, consenting or drug disposal records are often attributed to the lack of investigator’s supervision in ensuring compliance. The PI delegates responsibilities to the study team and may not provide adequate time to review the source data due to lack of time or commitment. The study documentation is completely left on the shoulders of study coordinator’s.

Various tools are used for data collection. At times sponsor provides source document worksheets to ensure complete documentation. If these worksheets are not designed accurately to align with the protocol and CRF source data quality is directly impacted. These worksheets are often completed as checkboxes without any additional notes, comments or supporting documents. Source document worksheets sometimes also result in multiple records. The sites continue to maintain the clinical practice routine documentation and worksheets are completed in addition for the study. As such, these worksheets are no longer a primary source and thus no source document.

Workload of the existing staff can be another important reason leading to poor documentation. This may cause errors like source data for one subject entered in another subject record, pages misfiled, use of incorrect consent forms and similar issues.

Study coordinator/PI work with various sponsors/CROs at a time. These different sponsors/CROs communicate different level of expectations regarding source documentation. If the site is not experienced enough and they do not have a standard procedure to follow they may get confused with variations in guidance they receive. This may negatively impact the quality of data.

Certain technical inadequacies may also lead to poor source documentation. For e.g., the ECG machine is old and does not print the date, time and subject identifiers, printer or fax machine does not work. If the fax is not working it may result in not receiving important data i.e., lab reports, data queries, investigational product allocation confirmations, SAE transmission confirmations, etc. Important email correspondence with sponsor/CROs if not printed and archived may get lost.

HOW CAN THE DOCUMENTATION BE IMPROVED?

Based on the various causes noted above, I would like to offer some suggestions to improve the quality of source documentation at sites.

• PI should delegate responsibilities to staff adequately trained in protocol and GCP. Particular training should be provided on ALCOA and other good documentation practice requirements. Medical decisions should be delegated to medically qualified staff. Training of site staff should be repeated at defined frequency. New hires should be adequately trained before trial participation.
• PI should commit for involvement, and supervision throughout the entire duration of the study. There should be an agreed and documented procedure for PI to ensure supervision of the study by meetings with site staff, monitors; review of documentation, timely resolution of medical, ethical or GCP issues. The PI or designated subinvestigators should validate the medical data. The PI should also supervise the work of SMO staff and external facilities if used. In case there are performance issues with SMO staff or external facility PI should immediately inform the supervisor as well as sponsor.
• Site should develop a SOP for good documentation. This SOP should be shared with the sponsor/CRO and agreed upon before the start of the trial. This SOP should address aspects including but not limited to consenting process, verifying eligibility, use of right tools such as diaries, source document worksheets, OPD papers, copies of prescriptions, etc; ways to avoid multiple records and in case of multiple records should define the source for the study, method of corrections, review of safety labs and other reports. Documented procedure at site level should encompass management, maintenance, archival and retrieval of source documentation. Sites should have measures for continuous improvement and maintaining high-quality data. Sites should develop process for quality control.
• Before the trial commences all technical aspects such as for e-CRFs, fax, printers, etc. should be clarified and issues resolved. In case of any difficulties during the trial, sponsor should be informed and back-up plans agreed upon till the issue is resolved. In case when original lab records or investigational records are sent to central location for assessment, process should be in place to ensure a duplicate copy or certified copy is available in the site source records.
• Sponsor/CRO also plays an important role in ensuring quality of source documentation. Sponsor/CRO should ensure PI’s commitment and involvement throughout the study. Sponsor/CRO should assess the site’s documentation practice during pre-study visit and during the study; provide training to the site staff to reinforce expectations. Time spent effectively during pre-study evaluation on source documentation would help a great deal to minimize documentation issues later. The source data and their respective capture methods should be clearly defined prior to trial recruitment i.e. in the protocol or study specific source data agreement.

CONCLUSIONS

Source documentation should demonstrate the ALCOA and other attributes as described by regulatory authorities and GCP. Source documentation related findings are the most commonly cited during inspections and audits. PI’s commitment and involvement in the trial makes a huge difference. Efforts to train the sites, understand the sites practices right from the pre-study visit and continuous monitoring and training would definitely help in improving and maintaining the quality of site source documentation practices.

Ultimately the source document should speak for itself. It should narrate the medical journey of the patient as it happened to an independent observer-an auditor or inspector and thus form a strong foundation for a good clinical research.

Acknowledgments

I would like to thank Jessica Parchman (Group Director) and Kristel Van De Voorde (Director) from Global Quality and Regulatory Compliance, Bristol Myers Squibb for reviewing the article and providing valuable suggestions in shaping this article.

Document Analysis as a Qualitative Research Method

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Research Management Documentation for Team-Based Research

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Project Manual Documentation Template - Outline

This outline provides a descriptive list of items to help you create a research management plan for you and your team. Consider all of the documentation possibilities presented here, then use your discretion to add/edit/modify to fit your project parameters. Depending on the size and complexity of your project, certain components may require separate and more detailed documentation. For example, data collection protocols may be referenced in a project organization protocol and live as their own stand-alone documents.

1. PROJECT OVERVIEW

Summary of Research: In a brief statement describe the research to be performed and the data to be developed. This could include a statement on the source of funding; research design and context; project history; aims and objectives; hypotheses; related publications and research outputs; etc.   

Roles and Responsibilities: Description of the research team. List team member names and contact information. Include additional details such as team member roles and responsibilities, both generally and specific to data management/organization. Provide information on data ownership and rights. Set guidelines for communication best practices; standards for teamwork and conduct; other general expectations (e.g., work required for publication credit, etc.).

Individual Team Member Documentation: Detail standards and practices for personal lab notebooks or project diaries. Include information such as documentation responsibilities; ownership of research materials; and sharing policies.

2. PROJECT MANAGEMENT AND ORGANIZATION PLAN

Folders and Files: Outline the project folder structures and location of files by type and/or stage of development (raw, processed, master, etc.). Set standards for folder or file naming conventions, including for versioning or modifications. Provide guidance on selecting file formats.

Storage and Backup: Explain the storage infrastructure and protocols for saving and backup (e.g., scheduling, testing, disposal, etc.). Detail how to handle security considerations, including access rights.

3. DATA COLLECTION AND PROCESSING DOCUMENTATION

Data Collection Methods: Describe the protocols, procedures, and workflows. List information about tools used such as instruments, hardware, and software. Give details of quality assurance procedures; information recorded about the data collection process itself; use of structured data entry documents (if any).

Data Processing Methods: Detail the protocols and procedures to clean the data and prepare it for analysis. List the hardware and software used; quality assurance procedures; information to be recorded about the data processing procedure itself.

Metadata: Provide contextual information about the data needed to discover, understand, and make use of it. Describe alignment with disciplinary standards (if any). Detail how to create or link to codebook or data dictionary which includes variables. Explain coding practices.

Sensitive Data Considerations: Explain how to adhere to requirements such as anonymization; special storage protections and permissions; disposal regulations. Include IRB considerations and link to/append compliance documents.

4. DATA ANALYSIS DOCUMENTATION

Data Analysis Methods: Describe the protocols, procedures, and workflows. List information about tools used such as hardware and software. Give details of quality assurance and quality control procedures; information recorded about the data analysis process itself (e.g., techniques, etc.).

Dataset Versioning: Outline how to provide clear identification and definition of versions; including distinction between versions.

Master Dataset Rules: Explain the designation of the master dataset. Describe protocols for using the master dataset.

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The following interactive tools present the Project Manual Documentation Template in a format that can be used for self-assessment purposes to aid in the creation of a research management document.

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Research Documentation

When publishing research , it is important to make documentation available so that readers can understand the details of the research design that the work reports. This includes all of the technical details and decisions that could influence how the findings are read or understood. Usually, this will involve producing a document along the lines of a methodological note or appendix. That document will describe how a given study was designed and how the design was carried out. The level of detail is in such a document should be relatively high. This page will describe some common approaches to compiling this kind of material and retaining the needed information in an organized fashion throughout the life of a research project.

• Research documentation provides the context to understanding the results of a given research output.
• There is no standard form for this documentation, and its location and format will depend on the type of research output produced.
• For academic materials, this documentation often takes the form of a structured methodological appendix.
• For policy outputs or online products, it may be appropriate to include an informative README webpage or document.
• The most important process for preparing this documentation will be retaining and organizing the needed information throughout the life of the project, so that the team will not have to search through communications or data archives for small details at publication time.

What to include in research documentation

Research documentation should include all the information that is needed to understand the underlying design for the research output. This can include descriptions of:

• Populations of interest that informed the study
• Methods of sampling or other sources of data about selecting the units of observation that were actually included in the study
• Power calculations and pre-analysis plans
• Field work, including data collection or experimental manipulation, such as study protocols and monitoring or quality assurance information
• Data collection tools such as survey instruments, search keywords, and instructions or code for API requests or database queries
• Statistical approaches such as definitions of key constructed indicators, corrections or adjustments to data, and precise definitions of estimators and estimation procedures
• Data completeness, including non-observed units or quantities that were planned or "tracking" information

All of the research documentation taken together should broadly allow a reader to understand how information was gathered, what it represents, what kind of information and data files to expect, and how to relate that information to the results of the research. Research documentation is not a complete guide to data, however; it does not need to provide the level of detail or instructions that would enable a reader to approach different research questions using the same data.

Documentation will take different forms depending on the information included. Much of it will be written narrative rather than, for example, formal datasets . Understanding research documentation should not require the user to have any special software or to undertake any analytical tasks themselves. Relevant datasets (such as tracking of units of observation over time) might be included alongside the documentation, but the documentation should summarize in narrative form all the information from that dataset that is likely to affect the interpretation of the research.

Structuring research documentation as a publication appendix

If you are preparing documentation to accompany the publication of an academic output such as a working paper or journal article, the most common form of research documentation is a structured supplemental appendix. Check the journal's publication process for details. Some publishers allow unlimited supplementary materials to be included in a format such as an author-created document. These materials may or may not be included under the peer review of the main manuscript and might only be intended to provide context for readers and reviewers. In this case you should provide complete information in that material. Other publishers expect all supplementary materials to be read and reviewed as part of the publication process. In this case you should provide the minimum additional detail required to understand the research here (since much of the appendix will likely be taken up by supplementary results rather than documentation), and consider other methods for releasing complete documentation, such as self-publication on OSF or Zenodo.

Since there is unlimited space and you may have a large amount of material to include in a documentation appendix, organization is essential. It is appropriate to have several appendices that cover different aspects of the research. For example, Appendix A may include information about the study population and data, such as the total number of units available for observation , the number selected or included for observation, the number successfully included, and descriptive statistics about subgroups, strata, clusters, or other units relevant to the research. It could be accompanied by a tracking dataset with full information about the process. Appendix B might include information about an intended experimental manipulation in one section, and information about implementation, take-up, and fidelity in a second section. It could be accompanied by a dataset with key indicators. Appendix C might include data collection protocols and definitions of constructed variables and comparisons with alternative definitions, and be accompanied by data collection instruments and illustrative figures. Each appendix should included relevant references. Supplementary exhibits should be numbered to correspond with the appendix they pertain to. More granular appendices are generally preferable so that referencing and numbering remains relatively uncomplicated.

There have been many attempts to standardized some of these elements, such as the STROBE and CONSORT reporting checklists . Journals will let you know if they expect these exact templates to be followed. Even if they are not required, such templates can still be used directly or to provide inspiration or structure for the materials you might want to include.

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• Research Paper Appendix | Example & Templates

Research Paper Appendix | Example & Templates

Published on August 4, 2022 by Tegan George and Kirsten Dingemanse. Revised on July 18, 2023.

An appendix is a supplementary document that facilitates your reader’s understanding of your research but is not essential to your core argument. Appendices are a useful tool for providing additional information or clarification in a research paper , dissertation , or thesis without making your final product too long.

Appendices help you provide more background information and nuance about your thesis or dissertation topic without disrupting your text with too many tables and figures or other distracting elements.

We’ve prepared some examples and templates for you, for inclusions such as research protocols, survey questions, and interview transcripts. All are worthy additions to an appendix. You can download these in the format of your choice below.

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Table of contents

What is an appendix in a research paper, what to include in an appendix, how to format an appendix, how to refer to an appendix, where to put your appendices, other components to consider, appendix checklist, other interesting articles, frequently asked questions about appendices.

In the main body of your research paper, it’s important to provide clear and concise information that supports your argument and conclusions . However, after doing all that research, you’ll often find that you have a lot of other interesting information that you want to share with your reader.

While including it all in the body would make your paper too long and unwieldy, this is exactly what an appendix is for.

As a rule of thumb, any detailed information that is not immediately needed to make your point can go in an appendix. This helps to keep your main text focused but still allows you to include the information you want to include somewhere in your paper.

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An appendix can be used for different types of information, such as:

• Supplementary results : Research findings  are often presented in different ways, but they don’t all need to go in your paper. The results most relevant to your research question should always appear in the main text, while less significant results (such as detailed descriptions of your sample or supplemental analyses that do not help answer your main question), can be put in an appendix.
• Statistical analyses : If you conducted statistical tests using software like Stata or R, you may also want to include the outputs of your analysis in an appendix.
• Further information on surveys or interviews : Written materials or transcripts related to things such as surveys and interviews can also be placed in an appendix.

You can opt to have one long appendix, but separating components (like interview transcripts, supplementary results, or surveys ) into different appendices makes the information simpler to navigate.

Here are a few tips to keep in mind:

• Always start each appendix on a new page.
• Assign it both a number (or letter) and a clear title, such as “Appendix A. Interview transcripts.” This makes it easier for your reader to find the appendix, as well as for you to refer back to it in your main text.
• Number and title the individual elements within each appendix (e.g., “Transcripts”) to make it clear what you are referring to. Restart the numbering in each appendix at 1.

It is important that you refer to each of your appendices at least once in the main body of your paper. This can be done by mentioning the appendix and its number or letter, either in parentheses or within the main part of a sentence. It’s also possible to refer to a particular component of an appendix.

Appendix B presents the correspondence exchanged with the fitness boutique. Example 2. Referring to an appendix component These results (see Appendix 2, Table 1) show that …

It is common to capitalize “Appendix” when referring to a specific appendix, but it is not mandatory. The key is just to make sure that you are consistent throughout your entire paper, similarly to consistency in  capitalizing headings and titles in academic writing .

However, note that lowercase should always be used if you are referring to appendices in general. For instance, “The appendices to this paper include additional information about both the survey and the interviews .”

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The simplest option is to add your appendices after the main body of your text, after you finish citing your sources in the citation style of your choice. If this is what you choose to do, simply continue with the next page number. Another option is to put the appendices in a separate document that is delivered with your dissertation.

Remember that any appendices should be listed in your paper’s table of contents .

There are a few other supplementary components related to appendices that you may want to consider. These include:

• List of abbreviations : If you use a lot of abbreviations or field-specific symbols in your dissertation, it can be helpful to create a list of abbreviations .
• Glossary : If you utilize many specialized or technical terms, it can also be helpful to create a glossary .
• Tables, figures and other graphics : You may find you have too many tables, figures, and other graphics (such as charts and illustrations) to include in the main body of your dissertation. If this is the case, consider adding a figure and table list .

Checklist: Appendix

All appendices contain information that is relevant, but not essential, to the main text.

Each appendix starts on a new page.

I have given each appendix a number and clear title.

I have assigned any specific sub-components (e.g., tables and figures) their own numbers and titles.

My appendices are easy to follow and clearly formatted.

I have referred to each appendix at least once in the main text.

Your appendices look great! Use the other checklists to further improve your thesis.

If you want to know more about AI for academic writing, AI tools, or research bias, make sure to check out some of our other articles with explanations and examples or go directly to our tools!

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Yes, if relevant you can and should include APA in-text citations in your appendices . Use author-date citations as you do in the main text.

Any sources cited in your appendices should appear in your reference list . Do not create a separate reference list for your appendices.

An appendix contains information that supplements the reader’s understanding of your research but is not essential to it. For example:

• Interview transcripts
• Questionnaires
• Detailed descriptions of equipment

Something is only worth including as an appendix if you refer to information from it at some point in the text (e.g. quoting from an interview transcript). If you don’t, it should probably be removed.

When you include more than one appendix in an APA Style paper , they should be labeled “Appendix A,” “Appendix B,” and so on.

When you only include a single appendix, it is simply called “Appendix” and referred to as such in the main text.

Appendices in an APA Style paper appear right at the end, after the reference list and after your tables and figures if you’ve also included these at the end.

You may have seen both “appendices” or “appendixes” as pluralizations of “ appendix .” Either spelling can be used, but “appendices” is more common (including in APA Style ). Consistency is key here: make sure you use the same spelling throughout your paper.

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Research Paper Template

The fastest (and smartest) way to craft a research paper that showcases your project and earns you marks. 

Available in Google Doc, Word & PDF format 4.9 star rating, 5000 + downloads

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Tried & tested academic format

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What It Covers

This template’s structure is based on the tried and trusted best-practice format for academic research papers. Its structure reflects the overall research process, ensuring your paper has a smooth, logical flow from chapter to chapter. Here’s what’s included:

• The title page/cover page
• Abstract (or executive summary)
• Section 1: Introduction 
• Section 2: Literature review 
• Section 3: Methodology
• Section 4: Findings /results
• Section 5: Discussion
• Section 6: Conclusion
• Reference list

Each section is explained in plain, straightforward language , followed by an overview of the key elements that you need to cover within each section. 

You can download a fully editable MS Word File (DOCX format), copy it to your Google Drive or paste the content to any other word processor.

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FAQs: Research Paper Template

What format is the template (doc, pdf, ppt, etc.).

The research paper template is provided as a Google Doc. You can download it in MS Word format or make a copy to your Google Drive. You’re also welcome to convert it to whatever format works best for you, such as LaTeX or PDF.

What types of research papers can this template be used for?

The template follows the standard best-practice structure for formal academic research papers, so it is suitable for the vast majority of degrees, particularly those within the sciences.

Some universities may have some additional requirements, but these are typically minor, with the core structure remaining the same. Therefore, it’s always a good idea to double-check your university’s requirements before you finalise your structure.

Is this template for an undergrad, Masters or PhD-level research paper?

This template can be used for a research paper at any level of study. It may be slight overkill for an undergraduate-level study, but it certainly won’t be missing anything.

How long should my research paper be?

This depends entirely on your university’s specific requirements, so it’s best to check with them. We include generic word count ranges for each section within the template, but these are purely indicative. 

What about the research proposal?

If you’re still working on your research proposal, we’ve got a template for that here .

We’ve also got loads of proposal-related guides and videos over on the Grad Coach blog .

How do I write a literature review?

We have a wealth of free resources on the Grad Coach Blog that unpack how to write a literature review from scratch. You can check out the literature review section of the blog here.

How do I create a research methodology?

We have a wealth of free resources on the Grad Coach Blog that unpack research methodology, both qualitative and quantitative. You can check out the methodology section of the blog here.

Can I share this research paper template with my friends/colleagues?

Yes, you’re welcome to share this template. If you want to post about it on your blog or social media, all we ask is that you reference this page as your source.

Can Grad Coach help me with my research paper?

Within the template, you’ll find plain-language explanations of each section, which should give you a fair amount of guidance. However, you’re also welcome to consider our private coaching services .

Additional Resources

If you’re working on a research paper or report, be sure to also check these resources out…

1-On-1 Private Coaching

The Grad Coach Resource Center

The Grad Coach YouTube Channel

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Study Management Templates and Guidance

A guide to regulatory documentation and maintaining high standards in human participant research

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What is this resource?

The study management templates are adaptable and downloadable templates that can be used to organize and maintain research study documentation as you would include in a regulatory binder.

The templates can also help you adhere to high standards of practice in the conduct of studies involving human participants. The study management templates are a University of Michigan resource available to all study team members.

These templates are designed to help meet requirements for FDA-regulated clinical trials. They may be useful, but not required, to organize study documentation for other studies as well. Please customize the templates to match your study-specific requirements. Guidance documents are also provided to assist you with study management.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.

Translational Science Categories:

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• International Court of Justice
• Secretariat
• Charter of the UN
• Decolonization
• Development
• Disarmament
• Environment
• Human Rights
• International Law
• Peacekeeping
• Research UN Mandates
• UN Budget, 2020-
• Universal Declaration of Human Rights (1948), Drafting History
• Convention on the Rights of the Child (1989) 35th Anniversary
• Introduction
• Meeting Records
• Official Records
• Resolutions & Decisions
• Functional Commissions
• Regional Commissions
• Search for conference documents

The UN holds conferences on many topics and has done so throughout its history.

This part of the research guide describes the types of documents, publications and information resources that may be issued before, during and after a UN conference, with examples and links to additional research guides.

Types of documents issued for UN conferences

• symbol elements that may used for this type of document: BP, CRP, WP
• Journal, daily programme
• List of participants/delegates
• National reports
• symbol element: NGO
• may have symbol and/or UN Sales Number, ISBN, ISSN, other identifiers
• proceedings or selected statements as well as outcome documents adopted by the conference
• Final act, if any, may be issued separately or as part of a report
• Declaration/ treaty text/ statute : any legal text that may have been adopted by the conference
• Press releases, audiovisual recordings and archival material and other non-official documentation, generally not held by the UN Library
• Meeting records, transcripts, summaries or summary records, verbatim records, audiovisual recordings
• symbol element that may used for this type of document: L.-
• includes summaries of background and convening; facts such as dates, places, meetings, participants, officers elected, documents issued and resolutions and decisions, including the text, if any, of final agreed outcome(s)
• Preparatory Committee
• Credentials Committee
• Drafting committee, legal committee, regional committees, etc.
• Expert groups, working groups, round tables, etc.
• Subsidiaries of some conferences have extensive documentation 
• Rules of Procedure
• Many UN conferences have or had websites with extensive information resources

NOTE: The terminology used to describe types of documents may vary. For example: these or other terms may be used for documents that contain record of what was said during formal meetings of the conference: statements, speeches, transcripts, meeting records, verbatim, interventions...

Conference outcomes documentation

Conference outcomes vary widely, depending on the purpose of the conference and the topic. Most UN conferences issue reports upon conclusion. Some examples of outcome documents are:

• Belgrade, 30 Aug.-10 Sept. 1965
• Vol. I:  E/CONF.41/2 (66.XIII.5) Summary Report
• Vol. II:  E/CONF.41/3 (66.XIII.6) Fertility, Family Planning, Mortality
• Vol. III:  E/CONF.41/4  (66.XIII.7) Projections, Measurement of Population Trends
• Vol. IV:  E/CONF.41/5  (66.XIII.8) Migration, Urbanization, Economic Development
• Mexico City, 19 June-2 July 1975
• Report: E/CONF.66/34 (76.IV.1)
• Declaration of Mexico on the Equality of Women and their Contribution to Development and Peace (1975), pages 2-7 of the report in English
• New York, Caracas & Geneva, 1973-1982
• Final Act: A/CONF.62/121
• Treaty text and status: UN Convention on the Law of the Sea (1982)
• meets annually
• Outcome: Paris Agreement (2015)
• example: United Nations Pledging Conference for Development Activities (2002)-- A/CONF.200/
• generally very little documentation

What makes UN conference documentation unique?

In the context of this guide, UN conferences are:

• example: UN conferences are different from sessions of the UN General Assembly
• related types of documentation: Host Country Agreements, resolutions thanking host country
• Held in Rio de Janeiro, 3-14 June 1992
• Known at the time as the Earth Summit, it later came to be called the Rio Conference
• UN Conference on Sustainable Development (2012) was known as Rio+20
• Rome Statute (1998) of the International Criminal Court
• Paris Agreement (2015) on climate change
• Heads of state or government, if considered a Summit
• States may be represented by diplomats and/or experts in the topic of the conference
• UN System organizations
• Non-governmental organizations (NGOs) or civil society representatives, and others
• related documentation: statements/proceedings/meeting records; list of participants/delegates; Credentials Committee report

Availability of UN Conference Documentation

• Not every conference has every type of document
• Some conferences have extensive, complex documentation, others may have few documents
• Projects are ongoing to scan and make them available in the UN Digital Library
• As the UN Dag Hammarskjold Library does not index documents issued outside of NY and Geneva, researchers should also check the Official Document System for conference documents issued from other duty stations. (This is a major area of disjoint between the UNDL and the ODS)
• Many UN conferences have/had websites with extensive information resources. Because UN conferences are usually time-limited events, these websites may not be maintained over the long-term. Web archiving services may have captured websites cited in UN documents and publications that are no longer found on the current UN website.
• Audiovisual Library of International Law - Historic Archives
• UN Calendar of Conferences website
• UN Diplomatic Conferences Official Records
• UN Document Symbols & Series Symbols by Dag Hammarskjöld Library Last Updated Aug 22, 2024 8031 views this year

Ask DAG! FAQs about conferences

Sample un conference.

Displayed below is an example of a UN conference and its pattern of documentation; for more examples and information see the UN Document Symbols & Series Symbols research guide.

A/CONF.151/

United Nations Conference on Environment and Development (1992)

• Established by General Assembly resolution 45/211 of 21 December 1990 & General Assembly Decision 46/468 (see A/INF/46/8/Add.2 , page 4) of 13 April 1992
• Meetings held in Rio de Janeiro, Brazil
• Dates of conference: 3 - 14 June 1992

Outcome document in 3 volumes: A/CONF.151/26/Rev.1

• Rio Declaration on Environment and Development, a series of principles defining the rights and responsibilities of States
• Agenda 21, a global plan of action to promote sustainable development 
• Statement of Forest Principles, a set of principles to underpin the sustainable management of forests worldwide
• Vol.II : Proceedings of the Conference
• Vol.III  +  Corr.1 : Statements made by Heads of State or Government at the summit segment of the Conference
• A/CONF.151/-
• A/CONF.151/PC/WG.I/- : Preparatory Committee - Working Group I
• A/CONF.151/PC/WG.II/- : Preparatory Committee - Working Group II
• A/CONF.151/PC/WG.III/- : Preparatory Committee - Working Group III
• Digital Library search results
• Report of the Credentials Committee - A/CONF.151/17
• Press releases
• Adoption of Texts on Environment and Development - A/CONF.151/RES/1
• Rio Declaration on Environment and Development - A/CONF.151/PC/DEC/4/10
• Rio Declaration - A/CONF.151/5/Rev.1
• The Global Partnership for Environment and Development : A guide to Agenda 21 - A/CONF.151/GUIDE/1
• List of Participants - A/CONF.151/PC/INF/5
• Provisional Agenda - A/CONF.151/1 & Corr.1
• Provisional Rules of Procedure - A/CONF.151/2
• SDG Knowledge Platform - Earth Summit
• Search for symbol:"A/CONF.151/*"
• << Previous: Regional Commissions
• Next: Voting >>
• Last Updated: Sep 13, 2024 10:40 AM
• URL: https://research.un.org/en/docs/ecosoc

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Documentary Research: What it is, methodology & free examples

Social scientists often conduct documentary research. Its primary use is to assess various documents in the interest of social or historical value. Researchers also conduct documentary research to study multiple documents surrounding events or individuals.

What is documentary research?

Documentary research is the research conducted through the use of official documents or personal documents as the source of information.

Documents can include anything from the following: 

• Directories
• Government statistical publications
• Gramophone records
• Photographs
• Computer files

The above may not fit the traditional bill of a “document”, but companies can use them towards documentary research since they contain information.

Documentary research is similar to content analysis, which involves studying existing information recorded in media, texts, and physical items. Here, data collection from people is not required to conduct research. Hence, this is a prime example of secondary research.

It is essential to consider the quality of the documents while using it as evidence on social relations and social meanings. Keep in mind that, unlike surveys and research interviews, the records are originally published/generated without keeping the purpose of research in mind. It is good practice to cross-verify documents against other similar documents before reaching a decision.

Documentary research examples

Bellow, we can find a few real-life examples of documentary research applied to companies’ daily events.

1. Social research studies

Although documentary research is not used extensively today, it is the go-to research method to conduct social research studies. For example, Karl Marx and Emile Durkheim used documentary research extensively for their research.

Karl Marx used documents like:

• Her Majesty Inspectors of Factories Reports
• Royal Commission
• Inland Revenue Reports

There’s also a record of his use of reports by the Medical Officer of the Privy Council, reports on children’s employment in factories, the Corn-laws, the Banking Acts, and Census Reports for Wales and England to name a few.

Durkheim, one of the founders of Sociology, wrote a book on suicide, which is recognized as the first modern example of a methodical and consistent use of documents for social research.

2. Archival inquiry

The field of sociology has a popular, longstanding tradition of documentary inquiry. Many historians refer to and rely on primary documents for their research. Historians give historical documents more emphasis while conducting research. Of course, as we evolve, virtual documents like emails will play a significant role in research activities conducted by these researchers.

3. Aesthetic interpretation

Documentary research is not limited to text only. Pictures, paintings, videos, audio files, monuments are also used to conduct research. Documentary researchers use these tools in addition to texts while studying social sciences. The use of these tools adds to the authenticity of the textual research, or may very well point out deviations in the findings.

This deviation suggests that investigators research more to draw accurate conclusions.

Documentary research methodology

Documentary research, if conducted thoroughly, can help develop a hypothesis or prove or disprove an existing theory. This of course depends on the methodology applied and the depth of research conducted. The researcher must conduct his/her own secondary research to analyze the contents before extracting it. They must handle the data scientifically.

Follow this four-step approach to control the quality of the content:

The authenticity of the documents

The credibility of the documents

Representativeness of the documents

The meaning derived from the documents

Let’s take a look at these in detail.

Authenticity implies whether the document’s origin is reliable, is the evidence genuine, are the intentions sincere, and what were the commitments to creating the document. The authenticity of the source is the primary criterion of documentary research.

Credibility means the subjective and objective components that make one believe the source of information and whether the data is free from distortion and error. The information must be trustworthy and must have some level of expertise.

Representativeness refers to whether the document represents a more extensive collection of the data point, and it is an aggregation of the topic being studied. That said, documents get distorted with time due to the inclusion of new factors, and a check has to be made to ensure the documents are representative.

Meaning means whether the findings are understandable and clear to be called evidence. The goal of examining documents is to understand its significance and meaning. Researchers must find out whether the document fits within the historical context or not.

Advantages of documentary study

Here are the advantages of the documentary research method:

• Data readily available: Data is readily available in various sources. You only need to know where to look and how to use it. The data is available in different forms, and harnessing it is the real challenge.
• Inexpensive and economical: The data for research is already collected and published in either print or other forms. The researcher does not need to spend money and time like they do to collect market research insights and gather data. They need to search for and compile the available data from different sources.
• Saves time: Conducting market research is time-consuming. Responses will not come in quickly as expected, and gathering global responses will take a huge amount of time. If you have all the reference documents available (or you know where to find them), research is relatively quick.
• Non-bias: Primary data collection tends to be biased. This bias depends on a lot of factors like the age of the respondents, the time they take the survey, their mentality while taking the survey, their gender, their feelings towards certain ideas, to name a few. The list goes on and on when it comes to surveying bias.
• A researcher is not necessary during data collection: The researcher doesn’t need to be present during data collection. It is practically impossible for the researcher to be present at every point of the data source, especially thinking about the various data sources.
• Useful for hypothesis: Use historical data to draw inferences of the current or future events. Conclusions can be drawn from the experience of past events and data available for them. 

Disadvantages of the method

Here are the disadvantages of the documentary research method:

• Limited data: Data is not always available, especially when you need to cross-verify a theory or strengthen your argument based on different forms of data.
• Inaccuracies: As the data is historical and published, there is almost no way of ascertaining if the data is accurate or not. 
• Incomplete documents: Often, documents can be incomplete, and there is no way of knowing if there are additional documents to refer to on the subject.
• Data out of context: The data that the researcher refers to may be out of context and may not be in line with the concept the researcher is trying to study. Its because the research goal is not thought of when creating the original data. Often, researchers have to make do with the available data at hand.

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Home » Documentary Research – Types, Methods and Examples

Documentary Research – Types, Methods and Examples

Table of Contents

Documentary Research

Definition:

Documentary research is a type of research method that involves the systematic investigation and analysis of existing documents or records. These documents can be in the form of written, visual, or audio materials, such as books, articles, photographs, videos, and audio recordings.

Documentary Research Methods

Documentary Research Methods for data collection are as follows:

Systematic Searching

This involves conducting a thorough and systematic search of documents to identify relevant information. Researchers can use keywords, search terms, and other techniques to locate relevant documents.

Content Analysis

This involves analyzing the content of documents to identify patterns, themes, and other insights. Researchers can use manual or computer-assisted methods to analyze the content.

Historical Analysis

This involves analyzing historical documents to understand past events, trends, and cultural contexts. Researchers can use primary and secondary sources, as well as oral histories and other forms of documentation.

Archival Research

This involves analyzing documents stored in archives such as government records, personal papers, and institutional records. Researchers may need to gain access to the archives, navigate complex cataloging systems, and handle fragile or delicate documents.

Case Study Analysis

This involves analyzing specific cases and the documents related to them to understand underlying causes and effects. Researchers may need to collect a range of documents related to the case, such as police reports, medical records, and witness statements.

Comparative Analysis

This involves comparing documents from multiple sources or locations to identify similarities and differences. Researchers can use a range of tools and techniques to compare documents, such as content analysis software or qualitative coding schemes.

Literary Analysis

This involves analyzing literary works such as novels, poems, and plays to understand themes, symbolism, and other literary devices. Researchers can use a range of methods, such as close reading and thematic analysis, to analyze literary works.

Ethnographic Analysis

This involves analyzing documents related to a specific culture or group to understand their beliefs, practices, and values. Researchers may need to collect a range of documents such as interviews, field notes, and artifacts to analyze the culture or group.

Visual Analysis

This involves analyzing visual media such as photographs, videos, and artwork to understand the meaning, symbolism, and cultural context. Researchers can use a range of methods such as content analysis, semiotics, and discourse analysis to analyze visual media.

Network Analysis

This involves analyzing the relationships between documents, individuals, or organizations to understand social networks and power dynamics. Researchers can use a range of methods such as social network analysis and organizational analysis to analyze networks.

Data Analysis Methods

Documentary Research Data Analysis Methods are as follows:

• Coding : This involves categorizing and labeling segments of data to identify patterns and themes. Researchers can use a range of coding techniques such as deductive coding, inductive coding, and grounded theory coding.
• Thematic analysis: This involves identifying recurring themes and patterns in the data to understand the meaning and significance of the content. Researchers can use a range of thematic analysis techniques such as content analysis, discourse analysis, and narrative analysis.
• Content analysis : This involves analyzing the content of the data to identify patterns, themes, and other insights. Researchers can use manual or computer-assisted methods to analyze the content.
• Statistical analysis : This involves analyzing numerical data to identify patterns, trends, and relationships. Researchers can use a range of statistical techniques such as regression analysis, factor analysis, and cluster analysis.
• Qualitative data analysis : This involves analyzing non-numerical data to identify patterns, themes, and other insights. Researchers can use a range of qualitative data analysis techniques such as phenomenology, ethnography, and grounded theory.
• Discourse analysis : This involves analyzing the language and communication in the data to understand the meaning, context, and social relationships. Researchers can use a range of techniques such as critical discourse analysis, narrative analysis, and conversation analysis to analyze discourse.
• Visual analysis : This involves analyzing visual media such as photographs, videos, and artwork to understand the meaning, symbolism, and cultural context. Researchers can use a range of methods such as content analysis, semiotics, and discourse analysis to analyze visual media.

Documentary Research Methodology

The steps involved in conducting documentary research using a systematic methodology include:

• Defining the research question : The first step is to define the research question or problem that will guide the research. This should be a specific, clear, and answerable question.
• Identifying relevant documents: The next step is to identify the relevant documents that can provide information on the research question. This may involve conducting a search of databases, archives, and other sources of information.
• Evaluating the quality of the documents: Once the documents have been identified, it is important to evaluate their quality and relevance to the research question. This may involve assessing the reliability, validity, and bias of the documents.
• Collecting the documents: The next step is to collect the documents that will be used in the research. This may involve obtaining permission to access the documents, making copies, or taking notes.
• Organizing the documents: The documents should be organized in a way that makes it easy to find and analyze relevant information. This may involve creating a database, spreadsheet, or other organizational tool.
• Analyzing the documents: The data collected from the documents should be analyzed using appropriate methods such as content analysis, thematic analysis, or discourse analysis. The data should be interpreted in relation to the research question.
• Drawing conclusions: The final step is to draw conclusions based on the analysis of the documents. This may involve synthesizing the findings, identifying patterns and trends, and making recommendations for future research or action.

Applications of Documentary Research

Some of the common applications of documentary research include:

• Historical research : Documentary research is commonly used in historical research to study past events, trends, and social issues. Historians use existing documents such as newspapers, diaries, and government records to reconstruct historical events and understand the social and cultural context.
• Legal research : Documentary research is often used in legal research to understand the legal context of a particular case or issue. Legal researchers use existing documents such as court cases, legislation, and legal opinions to analyze the legal issues and provide insights into the legal system.
• Social sciences: Documentary research is commonly used in social science research to study social phenomena such as social movements, political campaigns, and cultural practices. Social scientists use existing documents such as media reports, government records, and personal accounts to understand the social and cultural context of the phenomena.
• Marketing research : Documentary research is used in marketing research to understand consumer behavior, market trends, and competitor strategies. Marketers use existing documents such as industry reports, market data, and customer feedback to develop marketing strategies and make informed decisions.
• Education research: Documentary research is used in education research to study educational policies, practices, and outcomes. Education researchers use existing documents such as educational records, policy documents, and research studies to understand the factors that influence student achievement and inform educational policies.
• Business research: Documentary research is used in business research to study business practices, industry trends, and market dynamics. Business researchers use existing documents such as financial reports, industry publications, and customer feedback to analyze business performance and inform business strategy.

Examples of Documentary Research

Here are some real-time examples of documentary research:

• Investigative journalism : Investigative journalists often use documentary research to uncover hidden information or expose corruption. For example, a journalist may use existing documents such as government reports, financial statements, and leaked documents to investigate a company’s unethical practices or a government’s hidden agenda.
• Social media research : Social media researchers use documentary research to analyze user-generated content and social media platforms. For example, a researcher may use existing social media posts, comments, and tweets to study public opinion on a particular topic or track the spread of misinformation.
• Public policy research : Public policy researchers use documentary research to analyze government policies and their impact on society. For example, a researcher may use existing documents such as legislative records, budget reports, and policy briefs to study the effects of a particular policy on a particular population.
• Historical research : Historians use documentary research to reconstruct historical events and understand the social and cultural context. For example, a historian may use existing documents such as diaries, newspapers, and government records to study the impact of World War II on a particular region.
• Market research : Market researchers use documentary research to analyze market trends and consumer behavior. For example, a market researcher may use existing documents such as industry reports, market data, and customer feedback to develop a marketing strategy for a new product.
• Environmental research : Environmental researchers use documentary research to study the impact of human activities on the environment. For example, a researcher may use existing documents such as environmental impact statements, government reports, and scientific studies to understand the effects of climate change on a particular region.

Purpose of Documentary Research

The purpose of documentary research is to gather and analyze data from existing documents such as records, archives, newspapers, magazines, books, and other media sources. The goal of this type of research is to extract information and gain insights that are relevant to the research question or problem being studied. The purpose of documentary research can vary depending on the specific context and objectives of the research project. Here are some examples of the purposes of documentary research:

• To study historical events : Documentary research is often used by historians to study past events and understand the social and cultural context of the time period being studied.
• To analyze public policies: Documentary research is frequently used by policy analysts to evaluate the effectiveness of public policies and identify areas where improvements can be made.
• To understand social phenomena : Documentary research is commonly used in social science research to study social phenomena such as social movements, political campaigns, and cultural practices.
• To develop marketing strategies: Documentary research is used in marketing research to understand consumer behavior, market trends, and competitor strategies. Marketers use existing documents such as industry reports, market data, and customer feedback to develop marketing strategies and make informed decisions.
• To inform business decisions : Documentary research is used in business research to study business practices, industry trends, and market dynamics. Business researchers use existing documents such as financial reports, industry publications, and customer feedback to analyze business performance and inform business strategy.

When to Use Documentary Research

Here are some situations when documentary research might be a good fit:

• When the research question requires the analysis of existing data : Documentary research is useful when the research question requires the analysis of existing data sources such as records, archives, newspapers, magazines, and other media sources.
• When the research question involves historical analysis: Documentary research is frequently used in historical research to study past events and understand the social and cultural context of the time period being studied.
• When the research question requires the analysis of policy documents: Documentary research is often used in public policy research to evaluate the effectiveness of public policies and identify areas where improvements can be made.
• When the research question requires the analysis of marketing or business data: Documentary research is useful in marketing and business research to understand consumer behavior, market trends, and competitor strategies.
• When the research question requires a comprehensive analysis of a large data set : Documentary research can be useful when researchers need to analyze a large data set that would be difficult or time-consuming to collect through primary data collection methods.
• When the research question requires triangulation of data: Documentary research can be used in conjunction with other data collection methods such as interviews, surveys, or observations to triangulate data and verify findings.

Characteristics of Documentary Research

Here are some characteristics of documentary research:

• Non-experimental: Documentary research is a non-experimental research method, meaning that researchers do not manipulate any variables or conduct experiments in a controlled setting.
• Use of secondary data: Documentary research relies on secondary data sources such as existing documents, rather than collecting new primary data through surveys or observations.
• Historical and retrospective : Documentary research is often used to study historical events or retrospective phenomena such as public policies, social movements, or cultural practices.
• Objective and unbiased: Documentary research is based on existing documents that are typically considered objective and unbiased, which can add credibility to the research findings.
• Time-efficient and cost-effective: Documentary research can be a time-efficient and cost-effective research method, as it involves the analysis of existing data sources rather than collecting new primary data.
• Requires critical thinking and interpretation : Documentary research requires critical thinking and interpretation of the data sources to identify relevant information and gain insights that are relevant to the research question or problem being studied.
• Can be used in combination with other research methods: Documentary research can be used in combination with other research methods such as interviews, surveys, or observations to triangulate data and verify findings.

Advantages of Documentary Research

Here are some advantages of documentary research:

• Cost-effective : Documentary research is generally less expensive than primary data collection methods such as surveys or experiments, as it involves the analysis of existing data sources.
• Time-efficient: Documentary research is generally faster than primary data collection methods, as the data sources are readily available and do not require the time and resources associated with data collection.
• Non-intrusive : Documentary research is a non-intrusive research method that does not involve direct interaction with study participants. This can be particularly advantageous when studying sensitive topics or populations.
• Access to historical data : Documentary research provides access to historical data sources that may not be available through primary data collection methods.
• Objective and unbiased : Documentary research is based on existing documents that are typically considered objective and unbiased, which can add credibility to the research findings.
• Allows for triangulation of data: Documentary research can be used in combination with other research methods such as interviews, surveys, or observations to triangulate data and verify findings.
• Ethical considerations: Documentary research can be useful when conducting research on sensitive topics where ethical considerations may limit the use of primary data collection methods.

Limitations of Documentary Research

some limitations of documentary research are as follows:

• Limited control over data quality: Researchers have limited control over the quality and accuracy of the data sources used in documentary research, as they are often historical and not specifically designed for research purposes.
• Limited generalizability : The findings from documentary research may not be generalizable to other populations or contexts, as the data sources are often specific to a particular time period or location.
• Limited ability to answer specific research questions: Documentary research is limited to the data sources that are available, which may not always provide the information needed to answer specific research questions.
• Limited ability to explore causality: Documentary research is a non-experimental research method and does not involve the manipulation of variables, making it difficult to explore causality.
• Limited ability to explore complex phenomena : Documentary research may not provide a complete picture of complex phenomena, as the data sources may not capture all aspects of the phenomenon being studied.
• Limited ability to collect qualitative data: Documentary research is primarily a quantitative research method and may not provide rich qualitative data that can be obtained through other research methods such as interviews or observations.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Department of Health and Human Services

Food and drug administration.

• [Docket No. FDA-2018-D-1216]

Food and Drug Administration, HHS.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.

Support for eCTDv4.0 electronic submissions begins September 16, 2024. FDA will also continue to support eCTDv3.2.2 electronic submissions. Submit either electronic or written comments at any time.

You may submit comments as follows:

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov .
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instruction.”

Instructions: All submissions received must include the Docket No. FDA-2018-D-1216 for “Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 4.0.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be ( print page 75546) made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov . Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469 , September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf .

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

Jonathan Resnick, Center for Drug Evaluation and Research, Food and Drug Administration, [email protected] ; or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

According to the guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” (available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications ), submissions subject to section 745A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379k-1(a) ) must be submitted in eCTD format using the version of eCTD currently supported by FDA unless such submission is exempt from the electronic submission requirements or if FDA has granted a waiver. The version of eCTD currently supported by FDA is specified in the FDA Data Standards Catalog (available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​data-standards-catalog ). FDA plans to update the FDA Data Standards Catalog to add eCTDv4.0 upon publication of this notice. FDA will support both eCTDv3.2.2 and eCTDv4.0 submissions before eventually only supporting eCTDv4.0 submissions. FDA will provide advance notice of when the Agency will begin supporting electronic submission only in eCTDv4.0. Specifications for eCTDv3.2.2 and v4.0 are available on FDA's eCTD web page (available at: https://www.fda.gov/​drugs/​electronic-regulatory-submission-and-review/​electronic-common-technical-document-ectd ).

Dated: September 10, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.

[ FR Doc. 2024-20897 Filed 9-13-24; 8:45 am]

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