Monitoring is an essential part of quality management in clinical trials. According to Good Clinical Practice (GCP) and the latest developments in the regulatory environment, risk-based approaches in clinical trials are internationally encouraged, especially for academic IICTs, such approaches are essential to use limited resources efficiently. These guidelines describe the risk-based monitoring procedures for clinical trials and help determine the recommended risk category for a clinical trial.
This guidance document consists of two components:
- a risk-based monitoring (RBM) score calculator with seven risk categories including and a decision tree for determining risk categories
- a description of risk-based monitoring strategies for each risk category.
This guidance document’s scope covers clinical trials as defined by the Swiss Human Research Act (HRA). Even though it does not focus on research projects as covered by the Swiss Human Research Ordinance (HRO), the content is nonetheless applicable.The Guidelines for Risk-Based Monitoring (Version 3.0) were published as Appendix 3 of the Guidelines for Good Operational Practice (GGOP). We recommend using these guidelines together with the Risk-Based Monitoring Score Calculator.