11  Informed Consent Oversight

11.1 CRA Oversight Objectives

• Correct version in use (IRB-approved)
• Consent obtained before any protocol-required procedures
• Documentation complete and consistent (dates, times, signatures)
• Re-consent performed when required (amendments, new risk info)

11.2 Consent Review Checklist (During Monitoring)

• Correct ICF version in use; IRB approval dates match
• Participant (or LAR) signed/dated appropriately
• Person obtaining consent signed/dated appropriately
• All required signatures present (witness/translator if applicable)
• No study procedures performed before consent date/time
• Participant received a copy (documented per site practice)
• Re-consent completed when triggered; documented rationale if not

WarningCommon Consent Findings

Missing dates, wrong version, signatures out of order, and procedures done before consent are frequent inspection issues.

NoteOncology-Specific Considerations

• Consent language often includes genetics, tissue banking, future research, optional sub-studies
• Re-consent triggers may occur more often due to safety updates and amendments

NoteVaccine Trial Considerations

• High enrollment volume may increase risk of consent timing or documentation errors; verify consent completion prior to any study procedures.
• Rapid recruitment environments require careful verification of consent version control and timestamp accuracy.
• Ensure subjects have adequate opportunity for questions despite accelerated enrollment workflows.