45 Deviation Identification & Documentation

45.1 How Deviations Are Identified

Monitoring visits
Data review / listings
Safety review
Sponsor or CRO queries
Site self-reporting

45.2 CRA Responsibilities

Confirm deviation occurred (source verification)
Ensure site documents deviation
Verify required reporting pathways followed
Track deviation to resolution

45.3 Documentation Principles

Factual and objective
Traceable to source
Includes date, description, impact, action

Oncology-Specific Considerations

Dose modifications and delays often generate deviations
Imaging windows frequently missed due to scheduling complexity

Vaccine Trial Considerations

Missed or out-of-window visits may compromise immunogenicity or safety endpoint validity.
Vaccination timing and protocol-defined follow-up intervals are often critical to endpoint interpretation.
Deviations related to dosing schedule or specimen collection timing may require heightened review.