44  Deviation Framework & Definitions

44.1 What is a Protocol Deviation?

Any instance where study conduct differs from the approved protocol, GCP, or regulatory requirements.

44.2 Common Deviation Categories

• Informed consent errors
• Eligibility violations
• Missed or out-of-window visits
• Incorrect dosing or IP handling
• Missing assessments
• Safety reporting delays

44.3 CRA Reality Check

Not all deviations are catastrophic, but all must be documented, assessed, and addressed.