What should be done about deviations from the protocol?

• A. Ignore minor deviations
• B. Communicate deviations to the investigator and take appropriate action designed to prevent recurrence
• C. Prefer noncompliance when convenient
• D. Document deviations but take no corrective action

Answer: (B)

When a protocol deviation occurs, the priority is to protect participant safety and preserve data integrity by promptly addressing it with the right oversight and action. The best approach is to communicate the deviation to the investigator and implement appropriate corrective and preventive actions to prevent recurrence. This reflects the responsible flow in GCP: the investigator ensures adherence and the sponsor (and the study team) follows up with measures to reduce the chance of it happening again, such as retraining, review of procedures, or changes to how the protocol is implemented. Deviations must be documented and evaluated for impact, with actions taken to correct root causes so similar issues don’t recur.

Options that suggest ignoring deviations, favoring noncompliance when convenient, or documenting without taking any corrective action fail to protect participants or maintain data integrity, and don’t align with GCP expectations for deviation management.