12 IRB/IEC & Approvals

12.1 Approval Rules of Thumb (CRA Use)

No site activity begins before IRB/IEC approval (per protocol and site requirements)
All versions of protocol/ICF in use must be IRB/IEC-approved
Continuing review approvals must remain current (if applicable)

12.2 Approval Verification Workflow

flowchart LR
  A[Document Version Issued] --> B[IRB/IEC Review & Approval]
  B --> C[Site Implements Approved Version]
  C --> D[CRA Confirms Version Control at Visit]
  D --> E[File to Site Binder + TMF]

12.3 CRA Monitoring Checks

Current IRB approval covers current protocol version
ICF version in use matches IRB approval letter
Recruitment materials approved (if used)
Continuing review dates tracked; no lapse occurred
Local IRB requirements met (if multi-IRB environment)

Oncology-Specific Considerations

Safety updates and amendments are frequent → approval tracking must be disciplined

Vaccine Trial Considerations

Vaccine trials may operate under accelerated start-up timelines to support rapid enrollment. Ensure IRB/IEC approvals, consent versions, recruitment materials, and protocol amendments are fully documented and filed despite compressed activation schedules.