Documentation Recommendations for Campus-based DUHS IRB Studies

The Campus Oversight Organization wants to help Campus faculty follow the appropriate policies and guidelines for conducting and documenting human subjects research.

The following guidelines can help investigators understand expectations for study documentation. More detailed information is available from DOCR.

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

Subject Specific Documentation

You should keep separate files with information on each of your study subjects. Source documents should be kept in subject files and contain source data, which are the first time data were recorded.

For subject files, you should ensure:

  • The most recent, watermarked version of the consent form was used (printed from the "Study Documents" tab in eIRB immediately preceding the consent process)
  • The consent forms are signed and dated (by both the subject and the person giving consent) and contain subject initials on every page
  • The consent forms have 2 participant identifiers; such as name and date of birth, on every page in the top right corner
  • Signed forms of acknowledgement of receipt of the Notice of Privacy Practices (NOPP) (for non-Duke patients only)
  • Subject documents should be stored in secure location (locked file cabinets or secure database)
  • While SSNs should be collected for payment purposes, remember that these should be kept behind 2 locks and permanently redact at the earliest possible time.

Notes to File

When something unusual or unexpected occurs, you should create a “note to file” to explain the situation (who, what, where, when, why, how) and the appropriate corrective actions, including resolving the current situation and preventing future occurrences. Examples could include obtaining pencil signatures rather than pen, failing to obtain subject initials, etc.

Protocol deviations that should also be reported to the IRB include deviations that:

  • Affect subject rights/welfare
  • Affect subject safety
  • Affects integrity of the study data
  • Could affect the subject's willingness to continue study participation
  • Any deviation specifically required by the sponsor, institution, or the IRB

Most common Human Subjects Research Compliance audit findings

(source: DOCR)

  • Failure to follow the approved protocol consent
  • Subject signed the incorrect consent form version
  • Not re-consenting when appropriate
  • Research activities conducted prior to signing consent
  • Missing or incomplete data on Case Report Forms
  • Inappropriate documentation correction errors
  • Failure to document and/or report adverse events
  • Delegation log does not match the key personnel in eIRB
  • The RDSP in the eIRB does not match the current processes