Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS

1.2 Topics Addressed in This Book

1.2.1 Risk-Based Monitoring

Since 1990, the International Conference on Harmonisation (ICH) has brought together the regulatory bodies of the European Union, Japan, and the United States. The mission of the ICH is to define a set of technical and reporting guidelines for clinical trials to minimize the testing required in humans and animals to what is absolutely necessary to establish efficacy and safety, reduce development times, and streamline the regulatory review process. In particular, ICH Guideline E6 outlines standards for Good Clinical Practice (GCP) in the design, conduct, and reporting of clinical trials involving human participants [5]. GCP has two primary goals: to protect the well-being of subjects ...