Q&A Final
A Risk-Based Approach to Monitoring of Clinical Investigations — Questions and Answers
ABSTRACT — EDITORS' SUMMARY
Companion Q&A to the 2013 RBM guidance. Practical recommendations on monitoring plan development, risk assessment documentation, SDV approach, blinding safeguards, and root cause analysis. The most operationally useful FDA document on monitoring.
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SOURCE
PDF · CANONICAL LINK https://www.fda.gov/media/121479/download ↗ RELATED · SAME AUTHORITY