FDA Guidance on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

• By: Staff Editor
• Date: January 27, 2017
• Source: http://www.fda.gov

FDA Guidance on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

The conduct of clinical trials are monitored through variety of approaches that differ between businesses, government organization, and educational institutions. Considering this variability, the FDA guidance describes the risk based strategy for monitoring, including the use of on-site monitoring, centralized monitoring, and additional alternative monitoring techniques

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