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Monitoring, audit and inspection in clinical trials

Publication |
2009

Abstract

Publication is intended for all participants in clinical research - investigators, study team and CRAs. It describes history and legislation of "Good Clinical Practice" (GCP), the main role of investigators and CRAs, as well as monitoring procedures.

The publication also explains the scope and objective of GCP audits and GCP inspections and informs about misconduct/ fraud in clinical trials, violations of the standards and inappropriate ethical behaviour in clinical research.