Which actions should be reported promptly to the IRB/IEC?

• A. All of the above
• B. Deviations from or changes of the protocol to eliminate immediate hazards to trial subjects
• C. Changes increasing risk to subjects and/or affecting significantly the conduct of the trial
• D. All adverse drug reactions that are both serious and unexpected

Answer: (A)

In GCP, anything that can affect participant safety or the integrity of the trial should be brought to the IRB/IEC quickly so they can review and oversee the risk. The listed actions all fall into that category.

When a deviation from the protocol or a change is made to eliminate an immediate hazard to trial subjects, it is a safety-driven adjustment. Even though such urgent changes may be implemented to protect participants without waiting for full IRB review, they must be reported to the IRB promptly with the rationale and documentation. This keeps the oversight body informed and allows them to assess whether the change is appropriate and properly justified.

If a change increases risk to subjects or significantly affects how the trial is conducted, it raises new safety or ethical concerns and warrants IRB review and approval before being put into place. Prompt reporting ensures the IRB can evaluate the risk-benefit balance and approve any necessary amendments or additional safeguards.

All adverse drug reactions that are serious and unexpected signal new safety information about the drug. These SUSARs require expedited reporting to the IRB/IEC (and usually to regulatory authorities as well) so that subject protection measures can be considered and actions taken if needed.

So, all of these actions should be reported promptly to the IRB/IEC.