Improving Risk Assessment in Clinical Trials: Toward a Systematic Risk-Based Monitoring Approach
ABSTRACT: Regulatory authorities have encouraged the usage of a monitoring (RBM) system in clinical trials before trial initiation for detection of potential risks and inclusion of a mitigation plan in the monitoring strategy. Several RBM tools were developed after the International Council for Harm...
Main Authors: | , , |
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Format: | Article |
Language: | English |
Published: |
Elsevier
2021-01-01
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Series: | Current Therapeutic Research |
Subjects: | |
Online Access: | http://www.sciencedirect.com/science/article/pii/S0011393X21000217 |