WHO global benchmarking tool plus rev. VI+ ver. 1  - Clinical Trials Oversight (CT)

Overview

National Regulatory Authorities (NRAs) should have the legal mandate to authorize regulate and, if necessary, terminate clinical trials (CTs). The necessary requirements, guidelines, procedures and forms should be developed to be in line with country and region‐specific guidelines as well as major international CT guidance including guidelines from the Declaration of Helsinki, the Nuremberg code, International Council on Harmonization, and World Health Organization Good Clinical Practices. CT oversight is aimed at protecting the safety and rights of humans participating in CTs, ensuring that trials are adequately designed to meet scientifically sound objectives, and preventing any potential fraud and falsification of data.