Which document records treatment allocation and any decoding events and is maintained to support blinding integrity?

• A. Treatment Allocation and Decoding Documentations
• B. Final Report by Investigator to IRB/IEC Where Required
• C. Audit Certificate (if available)
• D. Signature Sheet

Answer: (A)

The key idea is preserving blinding by keeping a dedicated log of how participants are allocated and any events that reveal that allocation. This document records who received which treatment and any decoding (unblinding) events, including when and by whom they occurred, and why unblinding was needed. Keeping this record helps verify that the study remained blinded when appropriate, supports trial integrity during monitoring and audits, and ensures that unblinding is controlled and justified rather than ad hoc. Other options don’t capture allocation details or the history of decoding events, and they’re not used to support blinding integrity.