CRA (OPS): Twenty Copies of the Superseded Consent Form

Three separate issues, descending in severity:

1. Subject 015 enrolled under a superseded form (15 May). This is the most serious. The subject did not consent using the current IRB-approved information; new risk information added in v4.0 was never presented. Whether the subject's data can be used is decided by the sponsor and IRB, not the site - often permissible if the subject is promptly re-consented and nothing in v4.0 would have changed their decision, but the enrollment event remains a deviation. Reportable to the IRB.
2. Subject 012 not re-consented at the 10 June visit. A deviation from a specific IRB instruction. Rights and welfare are affected only if v4.0 contained information material to continued participation - check what changed. Deferring to 'end of study' is not acceptable; re-consent must occur at the next contact.
3. Missing page in subject 012's consent. Required elements (injury compensation, authorization language) are absent from the document. A verbal explanation does not substitute for a complete signed form unless the IRB waived documentation of consent, which is rare in a drug trial. Verify whether the page is missing only from the site file or also from the subject's copy.

• Stop using v3.0 today. Retrieve every remaining copy from the cabinet, the clinic rooms, and any coordinator's desk; quarantine or return them to the sponsor with a documented count.
• Re-consent subject 015 and subject 012 at the earliest contact using v4.0, with a documented consent discussion, subject's dated signature, and a PI or delegated-investigator signature. If subject 012's file copy is incomplete, re-consent addresses the gap and is simpler than reconstructing intent.
• Reconcile the consent inventory: how many v4.0 copies were received, how many issued, how many on file. This tells you the true scope.
• Audit all enrollments and visits since 2 May against the consent version on file. Assume there are more until proven otherwise.
• Fix the process: only current-version forms in the consent binder, version and approval date stamped on the folder, a documented check at each visit that the subject is on the current version, and a named person responsible for swapping forms within 24 hours of IRB approval.
• Retrain all staff involved in consent, with attendance records.

• IRB: all three issues, since they involve consent and therefore subject rights. Most IRBs require prompt reporting of serious noncompliance (commonly within 5 working days) and summary reporting of minor deviations at continuing review. Submit the PI's assessment and the CAPA, not just a description.
• Sponsor: notify within the contractual timeframe, typically 24-48 hours for significant issues, with a deviation log entry and a statement of whether data usability is affected.
• Documentation: deviation log entries with dates, subjects affected, root cause, corrective and preventive actions, and closure evidence. The PI signs.
• Monitoring report: findings, scope check, and follow-up verification items for the next visit.

Note what is not appropriate to do unilaterally: the CRA cannot tell the site the subject's data are fine, and cannot direct that the deviation be recorded as administrative. Both determinations sit with the sponsor and IRB.