Chapter I General Provisions Article 1 In order to ensure that the clinical trial process of drugs is standardized, the results are scientific and reliable, the rights and interests of subjects are protected, and their safety is guaranteed, this specification is formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and with reference to internationally recognized principles. Article 2 The management norms of drug clinical trials are the normative provisions on the whole process of clinical trials, including scheme design, organization, implementation, supervision, inspection, recording, analysis, summary and report. Article 3 All clinical trials of drugs, including human bioavailability or bioequivalence tests, shall be conducted in accordance with this specification. Chapter II Preparations and Necessary Conditions before Clinical Trials Article 4 All research on human body must conform to the ethical principles of Helsinki Declaration (Appendix 1) and the International Ethical Guidelines for Biomedical Research on Human Body promulgated by the Committee of International Organization of Medical Sciences, namely, fairness, respect for personality, striving for the maximum benefit of subjects and avoiding harm as much as possible. All parties involved in clinical trials must fully understand and follow these principles and abide by the laws and regulations on drug management in China. Article 5 To carry out clinical trials of drugs, there must be sufficient scientific basis. Before preparing the human trial, we must carefully consider the purpose of the trial, the problems to be solved, the expected therapeutic effect and possible harm, and the expected benefits should exceed the possible harm. The selection of clinical trial methods must conform to scientific and ethical standards. Article 6 Clinical trial drugs shall be prepared and provided by the applicant. Before conducting clinical trials, the applicant must provide preclinical research data of experimental drugs, including prescription composition, manufacturing process and quality inspection results. The pharmaceutical, preclinical and existing clinical data provided must meet the requirements of starting corresponding clinical trials, and at the same time, the efficacy and safety data related to the clinical trials of the experimental drug completed and being carried out in other regions should be provided to prove that the experimental drug can be used in clinical research and provide sufficient basis for its safety and the possibility of clinical application. Article 7 The facilities and conditions of clinical trial units must meet the needs of conducting clinical trials safely and effectively. All researchers should have the professional knowledge, qualification and ability to undertake this clinical trial, and have been trained in the management norms of drug clinical trials. Before the start of the clinical trial, the researcher and the sponsor should reach a written agreement on the trial scheme, monitoring, inspection and standard operating procedures of the trial, and the division of responsibilities in the trial. Chapter III Protection of Subjects' Rights and Interests Article 8 In the course of drug clinical trials, the personal rights and interests of subjects must be fully protected to ensure the scientificity and reliability of the trials. Ethics Committee and informed consent form are the main measures to protect the rights and interests of subjects. Article 9 In order to protect the rights and interests of subjects in clinical trials and provide public security, medical institutions participating in clinical trials shall set up ethics committees. The ethics committee shall include workers engaged in non-medical related professions, legal experts and members of other units, and shall be composed of at least five members of different genders. The composition and work of the ethics committee should be relatively independent and not influenced by any experimental participants. Article 10 Before the start of clinical trials, the experimental scheme can be implemented only after it has been examined and agreed by the ethics committee and signed with the consent. During the test, any modification of the test plan should be approved by the ethics Committee before implementation; Any serious adverse events in the experiment should be reported to the Ethics Committee. Article 11 The review opinions of the Ethics Committee on the clinical trial scheme shall be decided by voting after discussion, and members participating in the clinical trial shall not participate in the voting. Experts who are not members may be invited to attend the meeting as nonvoting delegates due to work needs, but experts who are not members have no voting rights. The Ethics Committee shall establish its working procedures, and all meetings and resolutions shall be recorded in written form and kept for five years after the clinical trial. Article 12 The Ethics Committee shall, from the perspective of protecting the rights and interests of subjects, review the experimental scheme in strict accordance with the following points:
(1) Whether the qualification, experience, enough time to participate in the clinical trial under consideration, staffing and equipment conditions of the researcher meet the requirements of the trial.
(two) whether the test plan is appropriate, including the research purpose, the risks and benefits that the subjects and other personnel may suffer, and the scientific nature of the test design.
(3) The method of selecting subjects, whether the information provided to subjects or their families or guardians or legal representatives about this experiment is complete and easy to understand, and whether the method of obtaining informed consent is appropriate.
(4) When the subjects are injured or even die due to participating in clinical trials, they should be given treatment or insurance measures.
(5) Whether the proposed changes to the test plan are acceptable.
(six) regularly review the degree of risk of subjects in clinical trials. Article 13 After receiving the application, the Ethics Committee shall convene a meeting as soon as possible, conduct review and discussion, issue written opinions, and attach a list of members attending the meeting, professional information and their signatures. The opinion of the ethics committee can be:
(1) agreed.
(2) Agree after making necessary modifications.
(3) disagree.
(four) to terminate or suspend the approved test. Article 14 The researcher or his designated representative must explain the details of the clinical trial to the subjects:
(1) Subjects should voluntarily participate in the trial and have the right to withdraw from the trial at any stage without discrimination or retaliation, and their medical treatment and rights and interests will not be affected.
(2) Subjects must be made aware that personal data during their participation in the experiment and the experiment are confidential. The ethics committee, the drug supervision and administration department or the applicant may, when necessary, consult the information of the subjects who participated in the experiment as required.
(3) the purpose of the test, the test process and duration, the inspection operation, the expected benefits of the subjects and the possible risks and inconveniences, and inform the subjects that they may be assigned to different test groups.
(4) During the experiment, the subjects can know the information related to them at any time. Subjects must be given enough time to consider whether they want to participate. For subjects who cannot express their consent, the above introduction and explanation shall be provided to their legal representatives. The interpretation process of informed consent should adopt the language and words that the subjects or their legal representatives can understand.
(5) In case of damage related to the experiment, the subjects can get treatment and appropriate insurance compensation.