27 Follow-Up & Issue Management
27.1 Issue Identification
Issues may include: - Protocol deviations - Data discrepancies - Missing documentation - Training gaps
27.2 Issue Documentation
Each issue should include: - Description - Reference (protocol / GCP) - Required action - Due date - Responsible party
27.3 Follow-Up Letters
Purpose - Summarize visit findings - Clearly document expectations - Establish accountability
CRA Best Practices - Be factual and objective - Reference protocol sections - Track closure formally
27.4 Escalation
Escalate issues when: - Repeated noncompliance occurs - Subject safety is at risk - Site responsiveness is inadequate