Who should document all protocol deviations?

• A. The sponsor alone is responsible for documenting deviations.
• B. Documentation is required only for major deviations.
• C. No formal documentation is needed unless IRB requests it.
• D. The investigator should document all protocol deviations, including those identified by themselves and those communicated by the sponsor.

Answer: (D)

Documentation of protocol deviations is the investigator’s responsibility. Recording every deviation in the trial record (with details on what happened, when, why, and what was done) creates a complete, auditable trail that supports participant safety and data integrity. The sponsor oversees monitoring and regulatory reporting, but they rely on the investigator’s records and do not replace the need for the investigator to document all deviations. Important point: deviations, even if minor, should be documented so they can be reviewed, assessed for impact on the study, and addressed with appropriate corrective actions. Documentation is not optional and isn’t contingent on IRB requests; it’s a standard part of conduct of the trial.