Regulatory Binders

Regulatory binders contain most of the essential study documents in an organized and readily-retrievable format. A table of contents is highly recommended.

Note that it is acceptable to include specific information regarding the location of these essential documents if they are electronic and/or housed elsewhere. However, some internal or external agencies may request everything in print during a review.

Documents that should be in the binder are:

  • Delegation of authority log
  • Current approved protocol and any previous versions. This includes, but is not limited to:
    • Research Summary
    • Current approved consent form and all previous consent forms
    • Recruitment materials
    • Written information provided to participants (if any)
    • Research Data Security Plans (RDSPs)
  • Any correspondence with the IRB:
    • Initial IRB approval notification
    • Protocol amendments approvals
    • Continuing review approvals
  • Any correspondence with the sponsor/FDA (if applicable)
  • Unanticipated event reports
  • Protocol deviation reports
  • Standard Operating Procedures
  • Financial Disclosures (if any)
  • Monitoring/audit reports (External from Duke ONLY)
  • CVs and medical licenses, if applicable, for Key Personnel
  • Documentation of Key Personnel training
    • Completion of required CITI modules
    • Completing of required DHRT modules
    • Study role-specific requirements

The following are considered part of the regulatory binder but may need to be kept separately as they likely contain sensitive information:

  • Screening log: Potential participants screened and documentation of exclusion reasons
  • Enrollment log: Participants enrolled meet inclusion criteria
    • Note: an electronic tool for the enrollment log is available from DOCR; please visit this page and find more information under "Duke Approaches and Tools" and under the heading "REDCap Enrollment Log template".

Additional requirements exist for studies investigating drugs/devices.

Items that should NOT be in a regulatory binder:

  • Internal audit reports
  • Complete study budget information
  • Complete study contract information
  • Any other sensitive information