Chapter I General Provisions Article 1 In order to ensure that the process of clinical trials of drugs standardized, the results are scientific and reliable, to protect the rights and interests of the subjects and safeguard their safety, in accordance with the "People's Republic of China *** and the State Drug Administration Law", with reference to the internationally recognized principles, the formulation of this specification. Article 2 Code of Practice for the Management of Clinical Trials of Pharmaceuticals is a standard provision for the whole process of clinical trials, including program design, organization, implementation, supervision, audit, record, analysis and summary and report. Article 3 All drugs undergoing various phases of clinical trials, including human bioavailability or bioequivalence test, shall be implemented in accordance with these norms. Chapter II Preparation and Necessary Conditions before Clinical Trials Article 4 All research on human subjects must comply with the ethical principles of the Declaration of Helsinki (Appendix 1) and the International Ethical Guidelines for Biomedical Research on Human Subjects issued by the Committee for International Organizations of Medical Sciences, namely, impartiality, respect for human personality, striving to maximize the benefits to the subjects and avoiding as much as possible the harm. All parties participating in the clinical trial must fully understand and follow these principles, and comply with the laws and regulations on drug management in China. Article 5: Clinical trials of drugs must be based on sufficient scientific evidence. Before preparing for a trial on human beings, the purpose of the trial, the problems to be solved, the expected therapeutic effects and possible harms must be carefully considered, and the expected benefits should exceed the possible harms. The selection of clinical trial methods must comply with scientific and ethical standards. Article 6 Drugs for clinical trials shall be prepared and provided by the sponsor. Before conducting the clinical trial, the sponsor must provide the preclinical research information of the drug for the trial, including the composition of the prescription, the manufacturing process and the quality inspection results. The provided pharmacological, preclinical and existing clinical data must meet the requirements for the commencement of the corresponding phases of clinical trials, and should also provide the test drug has been completed and other areas are undergoing clinical trials related to the efficacy and safety information to prove that the test drug can be used for clinical research, for its safety and clinical application possibilities to provide a sufficient basis. Article 7 The facilities and conditions of the unit conducting clinical trials must meet the needs of conducting clinical trials safely and effectively. All investigators shall have the professional expertise, qualifications and ability to undertake the clinical trial, and have been trained in the management of drug clinical trials. Before the commencement of the clinical trial, the investigator and the sponsor should reach a written agreement on the trial program, the trial's supervision, audit and standard operating procedures, as well as the division of responsibilities in the trial. Chapter III Protection of Rights and Interests of Subjects Article 8 In the process of drug clinical trials, the individual rights and interests of subjects must be adequately protected, and the scientificity and reliability of the trials must be ensured. The Ethics Committee and the Informed Consent are the main measures to safeguard the rights and interests of the subjects. Article 9 In order to ensure the rights and interests of subjects in clinical trials and provide public assurance thereof, an ethics committee shall be established within the medical institution participating in the clinical trial. The ethics committee shall have workers engaged in non-medicine related professions, legal experts and members from other organizations, and shall consist of at least five members with members of different genders. The composition and work of the ethics committee shall be relatively independent and free from the influence of any person involved in the trial. Article 10 Before the commencement of a clinical trial, the trial protocol shall be considered and agreed upon by the ethics committee and signed for approval before implementation. During the conduct of the trial, any modification of the trial protocol shall be approved by the Ethics Committee before implementation; any serious adverse events occurring in the trial shall be reported to the Ethics Committee. Article 11 The Ethics Committee shall make a decision on the review of the clinical trial protocol by voting after discussion, and the members who are involved in the clinical trial shall not vote. Experts who are not members can be invited to attend the meeting due to work needs, but the experts who are not members do not vote. The ethics committee shall establish its working procedures, and all meetings and their resolutions shall be recorded in writing, and the records shall be kept until five years after the end of the clinical trial. Article 12 The Ethics Committee shall, from the perspective of safeguarding the rights and interests of the subjects, strictly consider the trial protocols in accordance with the following points:
(1) whether the qualifications, experience, and availability of the investigators to participate in the clinical trial under consideration are sufficient, and whether the staffing and equipment conditions are in line with the requirements of the trial.
(ii) The appropriateness of the trial protocol, including the purpose of the study, the potential risks and benefits to subjects and others, and the scientific validity of the trial design.
(iii) The method of subject enrollment, the completeness and comprehensibility of the informational material provided to the subjects or their family members or guardians or legal representatives about the trial, and the appropriateness of the method of obtaining informed consent.
(d) Treatment or insurance measures are given in the event that the subject is harmed or even dies as a result of participation in the clinical trial.
(v) The acceptability of proposed amendments to the trial protocol.
(vi) Periodically reviewing the degree of risk to the subjects during the conduct of the clinical trial. Article 13 The Ethics Committee shall hold a meeting as early as possible after receiving the application, review and discuss it, and issue a written opinion with the list of members attending the meeting, their specialties and their signatures. The opinion of the Ethics Committee can be:
(i) Consent.
(ii) Agree with necessary amendments.
(iii) Disagree.
(iv) Termination or suspension of the approved trial. Article 14 The investigator or his/her designated representative must explain to the subjects the details of the clinical trial:
(1) Participation in the trial shall be voluntary and the subjects shall have the right to withdraw from the trial at any time during any stage of the trial without discrimination or retaliation, and their medical treatment and rights and interests shall not be affected.
(2) Subjects must be made aware that participation in the trial and their personal data during the trial are confidential. The ethics committee, the drug regulatory authority or the sponsor can access the information of the subjects participating in the trial when their work requires, according to the regulations.
(c) The purpose of the trial, the course and duration of the trial, the checking operation, the possible benefits expected from the subjects and the risks and inconveniences that may occur, informing the subjects of the different groups to which they may be assigned in the trial.
(d) During the trial, the subject may be given access to information materials relevant to him or her at any time. Sufficient time must be allowed for the subject to consider whether he/she wishes to participate. Subjects who are incapable of giving consent shall be provided with such orientation and instructions by their legal representative. The process of explaining informed consent shall be in a language and script that the subject or his or her legal representative can understand.
(v) In the event of trial-related damages, the subject shall have access to treatment and appropriate insurance reimbursement.