Participant-level documentation

Studies that do not capture any personal identifiers may not meet the definition of research with human participants. Contact the Campus IRB for further consultation and guidance about projects and requirements. 

Studies that capture personal identifiers 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 a study.

Contact the Campus IRB for more information.

Participant-level documentation is required for all clinical research studies. Protocols reviewed through the DUHS IRB are subject to the participant-level documentation requirements in 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 participant documentation immediately after visits to ensure it is complete, accurate, and follows “ALCOA” best practices.  Is documentation:
  • Attributable – Is it clear who documented the data/wrote the note?
  • Legible – Is the information readable?
  • Contemporaneous – Was the information documented when it happened?
  • Original – Is the documentation original source documentation (not photocopies)?
  • Accurate – Have records been checked for errors, completion and accuracy?
• A signed and dated Note to File should be used to explain any discrepancies, missing or incomplete data.

The informed consent process is ongoing throughout the research study, and its documentation is an essential element of conducting quality research. There are two key aspects of this: 1) documentation of the consent process, 2) the Informed Consent Form itself.

• Consent process: for Duke Health patients this 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.