GUIDANCE Final
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
ABSTRACT — EDITORS' SUMMARY
The foundational FDA RBM guidance. Encourages sponsors to design monitoring strategies proportional to identified risks; still cited as the policy framework underneath E6(R3) §3.11.4.
EMBEDDED PDF
METADATA
SOURCE
PDF · CANONICAL LINK https://www.fda.gov/media/116754/download ↗ RELATED · SAME AUTHORITY