The Elm

Tips for preparing a regulatory binder:

• Regulatory binders are required for all human subject research protocols approved by the Institutional Review Board (IRB), regardless of the risk level.
• Principal investigators (PI) are responsible for maintaining regulatory binder essential documents.
• Per the UMB Investigator Manual and Good Clinical Practice (GCP) (E6) sections 8.1, 8.2, 8.3, 8.4, regulatory binder essential documents demonstrate the compliance of standards of GCP and with all applicable regulatory requirements.

The regulatory binder houses your essential documentation, and includes information such as:

• IRB-Reviewed Materials and Approvals
• CVs and Medical Licenses
• Screening and Enrollment Logs
• Delegation Logs
• Study Team Training Documentation
• Study Communications
• Agreements
• Eligibility Checklists DSMB (Data and Safety Monitoring) and Adverse Events
  • Ensure compliance with the documents required by your sponsor/monitor.