How To Combine Quality Management With Risk-Based Monitoring In Clinical Trials
April 6, 2020
Meaghan Powers, lead consultant, Halloran Consulting Group penned an excellent article on integrating Quality Management with RBM
Meaghan tackles a number topics in the 3 Key Steps To Successful Execution.
- First, a risk assessment must be conducted both pre-study and ongoing during the trial.
- Second, a well-articulated study protocol should be developed based on factors identified during this risk assessment.
- Finally, an RBM approach should be tailored based on both the risk assessment and the protocol.
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