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.
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