Improving Risk Assessment in Clinical Trials: Toward a Systematic Risk-Based Monitoring Approach

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...

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Bibliographic Details
Main Authors: Firas Fneish, Frank Schaarschmidt, Gerhard Fortwengel
Format: Article
Language:English
Published: Elsevier 2021-01-01
Series:Current Therapeutic Research
Subjects:
Clinical trials
ICH-GCP
Mitigation plan
Risk-based monitoring
Risk methodology assessment
Online Access:http://www.sciencedirect.com/science/article/pii/S0011393X21000217

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http://www.sciencedirect.com/science/article/pii/S0011393X21000217

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