27 January, 2026
Author : Dr Vijaykumar Gawali

Topic : PROTOCOL DEVIATIONS – IDENTIFICATION, DOCUMENTATION & MANAGEMENT

1 Definition

A Protocol Deviation is any non-compliance with the approved study protocol, GCP guidelines, or sponsor/CRO instructions. It may be:

Types:

• Minor deviation: Does not impact participant safety or data integrity (e.g., visit window missed by 1 day).
• Major deviation: Impacts safety, rights, welfare, or data reliability (e.g., enrolling an ineligible patient).
• Violation: Serious breach requiring immediate reporting.

ICH-GCP and NDCT Rules require timely documentation, assessment, and corrective measures for all deviations.

2 Causes of Deviations

• Participant-related issues (missed visits, transportation issues)
• Staff-related errors (wrong lab tests ordered)
• System failures (power outage during sample processing)
• Protocol complexity
• Emergency medical situations

3 CRC Responsibilities in Deviation Management

3.1 Identify and Report

CRC must vigilantly detect deviations such as:

• Missed assessments
• Incorrect IP dispensing
• Out-of-window visits
• Failure to collect required samples
• Unsigned informed consent forms

CRC notifies:

• PI immediately
• CRA during monitoring
• EC if sponsor or protocol requires it

3.2 Document the Deviation

CRC prepares:

• Protocol deviation form
• Detailed explanation of what happened
• Impact assessment (does it affect safety/data?)
• PI comments/acknowledgement
• CAPA (Corrective and Preventive Action)

Filed in:

• ISF deviation section
• Submitted to sponsor

3.3 Implement CAPA

Examples:

• Staff retraining
• Creating checklist for sample processing
• Improving visit reminder system
• Updating internal process flows

CRA will verify CAPA implementation during monitoring.