When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should...

The primary factor in determining whether a protocol deviation should be reported to the IRB/IEC is whether the deviation impacts participant safety or the integrity of the study data. Any deviation that could pose a risk to participants must be reported promptly to ensure ongoing ethical oversight.

GCP guidelines mandate reporting of any protocol deviations that affect safety or data integrity to the IRB/IEC.

"Protocol deviations that impact the safety of participants or the integrity of the study must be reported to the IRB/IEC."

Objectives:

Maintain participant safety.

Ensure regulatory compliance through prompt reporting.