What types of changes must the investigator report to the IRB/IEC?

• A. The investigator must report deviations to eliminate immediate hazards, changes increasing risk to participants, SUSARs, and new information affecting participant safety.
• B. The investigator must report only SUSARs.
• C. The investigator must report only protocol amendments.
• D. The investigator must report financial discrepancies.

Answer: (A)

Protecting participants means the investigator must promptly inform the IRB/IEC about anything that could alter the risk to subjects or the study’s conduct. This includes deviations from the protocol that are taken to eliminate immediate hazards to participants, as well as any changes that increase risk or could affect participant safety. It also covers reporting SUSARs—suspected unexpected serious adverse reactions—since these events signal new or worse risks linked to the study. In addition, any new information that may affect the risk/benefit assessment or the safety of participants should be reported to the IRB. Financial discrepancies aren’t part of IRB reporting requirements under GCP. Protocol amendments themselves typically require IRB approval, except for urgent changes to eliminate hazards that can be implemented without prior approval and must be reported promptly.