What documentation should the sponsor obtain regarding IRB/IEC re-approvals or reevaluations?

• A. Only the initial approval
• B. Documentation and dates of re-approvals/re-evaluations with favorable opinion and any withdrawals or suspensions
• C. The trial budget
• D. Participant enrollment numbers

Answer: (B)

Ongoing ethical oversight requires formal re-approval from the IRB/IEC at defined intervals, and the sponsor must keep complete records of those re-approvals. The essential documentation includes the dates of each re-approval or reevaluation, the IRB/IEC’s favorable opinion, and any withdrawals or suspensions. This evidence shows that the study remains ethically reviewed and that participant protections are current, which is crucial for regulatory inspections and for validating that no study activity occurs under expired or suspended approval. Initial approval alone does not suffice because approvals have expiration dates and must be renewed to continue the trial. Documentation of budgets or enrollment numbers does not convey the status of ethical review and should not replace the required records of re-approvals.