Documenting the activities of each participant in a research study provides the opportunity to recreate the events of the study for each participating individual, which ensures the quality and integrity of the research data. While participant level documentation is required in some instances, it is best practice to maintain these records for all human participant research studies, regardless of funding or which IRB (Duke University or Duke Health) is used.
Maintenance of a research participant’s essential documents align with the principles of responsible conduct of research. While these activities are typically the responsibility of research staff, the PI is also responsible for overseeing compliance with study documentation practices.
Below are some fundamental concepts associated with the maintenance of participant-level documentation. For specific guidance documents and templates, check out the "Related Resources" section. For information on maintaining study-level documentation, access the Manage study and maintain institutional approval page.
Guidance for Campus IRB research protocols
Studies without personal identifiers
Studies with personal identifiers
Studies that capture personal identifiers will require completed informed consent forms and all study documentation to be kept in a secure locked space. All data should be stored on a data storage platform that is approved for sensitive data capture. Access SecureIt to compare institutionally supported data storage platforms to select the best fit for your study.
Contact the Campus IRB for more information.
Guidance for DUHS IRB research protocols
Requirements and overview of documentation
Participant level documentation is required for any clinical research study. Protocols reviewed through the DUHS IRB are subject to participant-level documentation requirements as specified by the Clinical Quality Management Program. Depending on the sponsor of the study, these records may also be reviewed by external monitors.
Important concepts to consider for all participant-level documentation
- Maintain all source documents – this is the document or location where the information is first recorded.
- All source documents or records should have two identifiers (neither of which should be SSN).
- Review your participant documentation immediately after the visit to ensure it is complete and accurate. Ensure that your documentation is complete and follows “ALCOA” best practices. Is your documentation:
- Attributable – Are you able to tell who documented the data/wrote the note?
- Legible – Is the information legible?
- Contemporaneous – The information should be documented when it happened.
- Original – Original source documentation (not photocopies) to guarantee credibility
- Accurate – Check for errors and ensure that records are thorough and correct.
- Use a signed and dated Note to File to explain any discrepancies, missing or incomplete data.
Informed consent process and documentation
The informed consent process is ongoing throughout the research study, and its documentation is an essential element of conducting quality research. The documentation of this process necessitates that research teams pay attention to two key documents or records: 1) documentation of the consent process; 2) the Informed Consent Form itself.
- Consent process for Duke Health patients should be documented in MaestroCare. For campus studies, or Duke Health studies involving non-patient cohort, the process should be documented in the participant’s file or in the study’s database. At a minimum, documentation of the process should include information about the outcome of initial screening for eligibility, the date of the consent, and who the staff member was that conducted the informed consent process.
- The original informed consent document, with two identifiers, is to be kept with the study record. A signed copy of the consent form is to be provided to the participant and another copy sent to Health Information Management to be uploaded to MaestroCare.
For studies reviewed through the Duke Health IRB, an enrollment log is typically maintained and generated in Oncore. The log includes a list of all participants who are screened and/or enrolled in the study. Refer to the "Related Resources" section on this page to find tip sheets for registering participants and generating enrollment logs.
For industry-sponsored research, enrollment logs may be provided by the sponsor, and should be maintained in accordance with sponsor guidelines.