Drug Evaluation Committee Toward the Establishment of a Quality Control System Led by Medical Institutions Proposal to introduce Risk based approach
Clinical Evaluation Subcommittee
June 2015
The importance of quality control of clinical trial operations at medical institutions from the viewpoint of the source of clinical trial data was described, and quality control based on the Risk Based Approach (RBA), which identifies, analyzes, and evaluates risks before the start of a clinical trial and establishes a mechanism and system to prevent errors from occurring, was proposed. It also described the Risk Based Approach to Monitoring (RBM) to be implemented by the sponsor. Recently, medical institutions are required to establish their own quality control systems in addition to investigator-initiated clinical trials, such as mandatory monitoring and auditing in clinical research. We hope that this document will provide hints for quality control of clinical trials and clinical research operations at medical institutions and help build a better implementation environment.
In order to provide hints for medical institutions starting or aiming to further improve their quality control efforts through RBA, we have prepared a risk sheet with specific examples of risk assessment and attached it for your reference.