FDA: Guidance for Industry - Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring
At the beginning of August, the FDA released a guideline on monitoring of clinical trials. This document is the final version of a draft dated August 2011 in which a few comments have been integrated. The guideline includes for example more details about the performance of risk-based monitoring and monitoring technique.
Źródło wiadomośći: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf