The Code of Quality Management for Drug Clinical Trials is interpreted

, the background of the revision of the Code
new revised Code of Quality Management for Drug Clinical Trials (No. 57 of 2020) was issued on 23 April 2020 and will take effect from 1 July 2020. In 2003, the State Food and Drug Administration issued and implemented the Code of Quality Management of Clinical Trials of Drugs (formerly Decree No. 3, referred to as the Code), which has played a positive role in promoting the normative research and improving quality of clinical trials in China.
With the rapid development of drug research and development in China and the deepening of the reform of drug review and approval system, some of the provisions of the Code are no longer applicable, the emergence of new concepts in the field of drug clinical trials and the application of new technologies, such as risk-based quality management, electronic data, etc., have not been included in the Code; For the subject's rights and interests, the lack of safety and security, need to be clear and detailed requirements in the Code, the national drug regulatory authorities to join the International Coordinating Committee for the Technical Management of Human Medicines Registration (ICH) and become a member of the Management Committee, should follow and implement the relevant guiding principles, the Code and ICH GCP guidelines in the body there are great differences, the Code needs to be modified and updated accordingly to meet the needs of drug regulatory work.Second, the main idea of the revision of the CodeThe Code is the technical requirement of the whole process of drug clinical trials, and is also the main basis for the supervision and management of drug clinical trials by drug regulatory departments and health authorities. The revision of the Code implements the Opinions of the State Office of the State Office on Deepening the Reform of the Review and Approval System to Encourage Drug Medical Device Innovation (Hall Word (2017) No. 42), and in accordance with the newly revised Drug Administration Law, with reference to international practice, highlights problem-oriented, refines and clarifies the responsibilities of all parties involved in drug clinical trials, and is consistent with the basic requirements of the ICH technical guidelines.Third, the scope of application of the Code
The Code applies to drug clinical trials for drug registration. Activities related to drug clinical trials should comply with this Code.Fourth, the main content of the revision of the Codethe revision of the Code from the original more than 9000 words to more than 24,000 words, from the original 13 chapters 70 to 9 chapters 83. The revision of the Code retains 5 chapters of general rules, researchers, bidders, pilot schemes, by-laws, 4 chapters on terminology and definition, ethics committee, researcher manual, necessary document management, etc., and removes pre-clinical trial preparation and necessary conditions, protection of the rights and interests of subjects, duties of inspectors, records and reports, data management, etc. With statistical analysis, the management of experimental drugs, quality assurance, multi-center trial 8 chapters, its chapters related to the content in accordance with the subject of responsibility and the test link adjusted to the corresponding chapters;
(1) To refine and clarify the responsibilities of the participants. As a separate chapter, the Ethics Committee defines its composition and operation, ethical review, procedural documents and other requirements. Highlight the main responsibility of the bidder, make it clear that the bidder is the ultimate responsible person for the quality and reliability of clinical trial data, and strengthen the supervision of outsourcing work. The contract research organization shall implement quality assurance and quality control. Researchers have clinical trial division of authority and supervision responsibilities. Clinical trial institutions shall set up corresponding internal management departments to undertake the corresponding management of clinical trials.
(ii) Strengthen the protection of the subjects. The Ethics Committee should pay special attention to vulnerable subjects, examine whether subjects have been unjustly affected, and accept and deal with the relevant claims of subjects. When formulating the plan, the candidate clearly protects the key links and data of the subject, and the supervision plan should emphasize the protection of the subject's rights and interests. The researcher should pay attention to the subject's other diseases and combination medication, receive the safety information provided by the candidate should consider whether the subject's treatment needs to be adjusted, etc.
(iii) Establish a quality management system. The bidder shall establish a quality management system for clinical trials, conduct quality management based on risk, strengthen quality assurance and quality control, and establish an independent data monitoring committee to conduct risk assessment-based monitoring. Researchers should supervise all researchers to implement pilot programs and conduct clinical trial quality management to ensure that source data is authentic and reliable.
(4) Optimize security information reporting. The criteria, paths, and requirements for the reporting of safety information by researchers and candidates during clinical trials are defined. The researcher reported all serious adverse events to the bidders. The Ethics Committee requires researchers to report any suspicious and undesirable serious adverse reactions in a timely manner. Bidders analyze and evaluate the various types of safety information collected and quickly report suspicious and undesirable serious adverse reactions to all parties involved in clinical trials.
(5) Standardize the application of new technologies. The electronic data management system should be verified by reliable system to ensure the integrity, accuracy and reliability of the test data. When the information system of clinical trial institutions has the conditions for establishing electronic medical records of clinical trials, researchers should prefer to use them, and the corresponding computerized system should have perfect authority management and inspection track.
(vi) Reference to international clinical supervision experience. The implementation of clinical trials shall comply with the principle of conflict of interest avoidance, the clinical trial drugs used in biological equivalent trials shall be sampled, preserved, etc., the specific time and personnel of the subject's informed consent shall be recorded in the medical history records, and if the problem of violating the test plan or the Code is serious, the candidate may hold the relevant personnel accountable and report to the drug supervision and administration department.
(7) Reflects the requirements of the medical management of the competent department of health care. The composition and filing management of the ethics committee shall meet the requirements of the competent department of health and health, and the bidder shall report suspicious and unannored serious adverse reactions to the drug regulatory department and the competent department of health and health. (State Drug Administration)