This notified document is drafted to strengthen the quality control of drug clinical trials, standardize the process of drug clinical trial research, and ensure the data of clinical trial to be scientific, authentic and reliable so as to protect the benefit and safety of subjects.
This notified document contains 8 chapters and 81 articles, including General Principles, Institutional Review Board (IRB), Investigator, Sponsor, Clinical Trial Protocol, Investigators Brochure (IB), Essential Documents and Supplementary Provisions. According to the current administrative situation on drug clinical trials and after fully considering international practices, the document further details responsibility of all parties related to drug clinical trials and sets up corresponding management requirements. It emphasizes the scientific and ethical nature of clinical trials, focuses on the protection of vulnerable subjects, optimizes the composition of IRB and provides requirements on the frequency of follow-up reviews. It also focuses on reports of Serious and Unexpected Adverse Event, refines the requirements on source records, adds investigator's oversight on research teams and third parties providing services, and strengthens sponsors responsibility on risk-based quality control and oversight for outsourcing. Besides, the notified document stresses that methods used in quality control should match with trial risks and the importance of data collected, increases and refines the requirements on management of electronic systems, and clarifies the contents of IB.