If changes significantly affect the conduct of the trial or increase risk to subjects, how should the investigator report?

If changes significantly affect the conduct of the trial or increase risk to subjects, how should the investigator report?

• A. Notify only the participants.
• B. Promptly provide written reports to the sponsor, the IRB/IEC, and where applicable the institution.
• C. Wait until the next annual review.
• D. Inform the sponsor verbally only.

Answer: (B)

When changes significantly affect how a trial is run or increase risk to participants, the investigator must communicate promptly and in writing to all relevant oversight and monitoring bodies—the sponsor, the IRB/IEC, and the institution (where applicable). This timely written report allows the sponsor to update regulatory submissions and monitoring plans, the IRB/IEC to reassess risk and consent if needed, and the institution to ensure appropriate governance and oversight. Verbal notices or waiting for the next annual review would delay critical risk assessment and oversight, and reporting only to the sponsor does not provide the necessary documentation to the ethics board and the institution.

When changes significantly affect how a trial is run or increase risk to participants, the investigator must communicate promptly and in writing to all relevant oversight and monitoring bodies—the sponsor, the IRB/IEC, and the institution (where applicable). This timely written report allows the sponsor to update regulatory submissions and monitoring plans, the IRB/IEC to reassess risk and consent if needed, and the institution to ensure appropriate governance and oversight. Verbal notices or waiting for the next annual review would delay critical risk assessment and oversight, and reporting only to the sponsor does not provide the necessary documentation to the ethics board and the institution.