Source Documents and Source Data
Study documentation serves as evidence to demonstrate the conduct of the research, the quality of the data collected and the compliance of the Investigator with applicable regulatory and institutional requirements.
One type of study documentation that study teams need to maintain is documentation to support protocol adherence (reference study documentation requirements and OHSP Policy 901: Investigator Responsibilities).
This type of study documentation should demonstrate:
- that you completed the procedures defined in approved protocol, in the manner defined by the approved protocol; and
- the integrity of the data collected.
This responsibility is typically met through that maintenance of ‘source documents’ and data collection tools (also referred to as case report forms).
Definitions: Source documents and source data
Source documents are ‘original documents, data and records’ and include documents such as hospital records, laboratory reports, academic records, memoranda, subject diaries, assessment measures, and pharmacy dispensing records. Source data is the information recorded in a source document, such as clinical findings and observations.[1]
examples of source documents and corresponding source data
| Source Document | Corresponding Source Data |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | Global PSQI score |
| Subject diary | Anxiety symptoms & frequency |
| Visual Analog Pain Scale (VAS) | Level of pain |
| Laboratory report | Vitamin D level |
| Medical record | Weight |
| Academic transcript | Grade point average |
What’s the difference between a source document and a data collection tool?
Data collection tools (also referred to as Case Report Forms [CRF]) are paper or electronic forms/instruments that are used to facilitate the collection of data. Depending on the nature of the research, you might use a data collection tool to:
A. Record original data, e.g., an investigator measures a subject’s grip strength using a hand dynamometer and records the measurement;
B. Record data that was originally collected for another purpose (outside the context of the research), e.g., a study coordinator records a blood pressure measurement from the medical record; or
C. Record data that was collected for study purposes from another study-specific source, e.g., a research assistant records the total carbohydrate, fat and protein grams consumed by a subject based on what the subject recorded in their the food diary.
Depending on how a data collection tool is used, it may or may not be considered a source document.
In Item A above, where the investigator records the subject’s grip strength, the data collection tool is the original (first) source of documentation of the data. Therefore the data collection tool would also be considered the source document.
Whereas in Items B and C, the data collection tool would not be consider the source because it is not where the data was originally documented (respectively, the medical record and food diary are the source documents).
Why does it matter?
A key attributes of ‘good’ study documentation, as identified in the ALCOAC standard, is maintaining original documentation (i.e., source documentation). This is because original documentation provides accurate information (accuracy being another key attribute of study documentation), which ultimately effects the precision with which a study team is able to test hypotheses and meet the aims of the research.
Therefore, during the planning phase of the research, study teams need to carefully consider:
- How study procedures will be documented; and
- How the data flows from the subject to the study database.
Generally, it is best practice to consider each data point(s) from each study procedure independently and determine what each corresponding source document is.
Some procedures, by virtue of their conduct, will result in corresponding source documentation–e.g., a blood sample that gets sent to a certified laboratory for analysis will result in a lab report or a survey/assessment form gets completed. The same is true when pre-existing data is collected from routine procedures performed outside the context of the research–e.g., collecting current medications maintained in the medical record or a standardized test score maintained in an academic record.
Some procedures, on the other hand, will require the creation of study-specific records in order to document the conduct of the procedures and resulting data. It is best practice to make maximum use of original source documentation (i.e., documentation that exists by virtue of the conduct of the procedure) and create study-specific documentation only for:
- procedures lacking an original source (e.g., verbal assessments of eligibility criteria, interviews, or other study-specific procedures); or
- to support compliance (e.g., study checklists).
Study teams should also try to avoid unnecessary duplication of documentation (e.g., recording the results from a lab report into additional CRFs and then into an electronic database) when possible in order to avoid transcription and data entry errors. [3]
Additional details
The ‘good’ documentation attributes identified above (original and accurate) are specifically identified as investigator responsibilities related to the maintenance of study records in guidance applicable to research regulated by the Food & Drug Administration (FDA). FDA (2018) and International Council for Harmonization (ICH) Good Clinical Practice (2016) guidance specifically states:
- “The investigator/institution should maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site’s trial subjects. Source data should be attributable, legible, contemporaneous, original, accurate, and complete…” (Section 4.9.0)
- “Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained.” (Section 4.9.2)
- “When a copy is used to replace an original document (e.g., source documents, CRF), the copy should fulfill the requirements for certified copies.” (Section 8.1) [1,2]
This means that Investigators conducting FDA-regulated research should ensure that source documents (inclusive of data collection tools or CRFs that act as source documentation as well as any other type of source document–e.g., components of a medical record and subject-completed measures/diaries) should be maintained by the site. Doing so validates the existence of the subject and the integrity of the data.
The FDA’s Bioresearch Monitoring Program (BIMO) Compliance Program Manual for Clinical Investigators and Sponsor-Investigators (i.e., the FDA inspection site manual) further reinforces this requirement, noting that “when an inspection occurs… it will include a comparison of the data submitted to FDA with source documents…” for the purposes of data verification.
- International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) – Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). (2016, November 9). Retrieved March 30, 2020 from the ICH
- Food & Drug Administration (FDA) Guidance for Industry – E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R2). (2018, March). Retrieved March 30, 2020 from the FDA
- Mathieu, M (ed.). (2009, May). Good Clinical Practice: A Question & Answer Reference Guide. Needham, MA: Barnett International.
Related resources
Recorded training sessions
Archived UR-HRPP Educational Forums are available. To access recordings listed below, follow our Blackboard Self-Enrollment Instructions and enroll in the course titled ‘UR-HRPP Educational Materials’:
- 12/9/2021: Essential Study Documentation – Part 1
- 1/21/2022: Essential Study Documentation – Part 2