GCP, named Good Clinical Practice in Chinese, is a standard regulation that regulates the whole process of drug clinical trials. The purpose of GCP is to ensure the standardization of the clinical trial process, the scientificity and reliability of the results, protect the rights and interests of the subjects and ensure their safety. GCP was promulgated by the Ministry of Health on March 2, 2003, 1998, and revised and implemented on September 6, 2003.

Extended data

1On March 2, 998, the Ministry of Health promulgated the Management Standard for Drug Clinical Trials (Trial); After the establishment of the US Food and Drug Administration, the standard was further discussed and revised, and was officially implemented on September 1 2003. The quality management standard of drug clinical trials is the standard regulation of the whole process of drug clinical trials, including scheme design, organization and implementation, supervision, inspection, recording, analysis, summary and report.

Refer to GCP (Quality Management Standard for Drug Clinical Trials) _ Baidu Encyclopedia?