What documentation should be provided to sponsor and IRB/IEC if termination occurs without sponsor agreement?

• A. A detailed written explanation of the termination or suspension
• B. A brief phone summary
• C. No documentation is required
• D. The final publication

Answer: (A)

When a study is terminated or suspended, the investigator must notify the sponsor and the IRB/IEC in writing and explain the reasons for the termination or suspension. A detailed written explanation is required because it creates an auditable record that supports safety and regulatory oversight. It helps all parties understand what happened, what risks were identified, and how participant protection is being maintained.

A thorough explanation should outline key elements: the date of termination or suspension, clear reasons (e.g., safety concerns, protocol compliance issues), how many participants are affected, the status of enrolled participants and any follow-up plans, steps taken to protect participants and data integrity, and how data generated up to that point will be managed or reported. This lets the sponsor, IRB/IEC, and, if applicable, other authorities, assess impact and determine any further actions needed.

A brief phone summary does not provide the required formal documentation, and claiming no documentation is needed would fail to meet GCP expectations. A final publication is not the appropriate mechanism for notifying sponsors or IRBs about a termination; it disseminates results, not the immediate action and reasoning behind the termination.