Drug clinical trial quality management standard

Chapter I General Provisions I. Preparation Stage of Clinical Trials

Clinical Trial Preservation Documents Investigator Sponsor 1 Investigator's Manual Preservation Preservation 2 Trial protocol and its amendments (signed) Preservation of the original Preservation 3 Case Report Forms (Sample Forms) Preservation Preservation 4 Informed Consent Forms Preservation of the originals Preservation 5 Financial Provisions Preservation Preservation 6 Multi-Party Agreements (signed) (Investigator, Sponsor, Contract Research Organization Quality control certificates of laboratory operations Save the original Save the original 15 Labeling of the test drug Save the original 16 Shipping documents of the test drug and test-related materials Save the original 17 Pharmacovigilance certificates of the test drug Save the original 18 Blinding protocol for blinded trials Save the original 19 General randomization table Save the original 20 Supervisory report Save the original II. Clinical trial conduct phase

Clinical trial save the documents Investigator Sponsor 21 Updated copies of the investigator's manual preserved preserved 22

Updated preservation of other documents (protocols, case report forms, informed consent forms, written status

notices) preserved preserved

Preserved

23 Curriculum vitae of the new investigator preserved preserved original 24 Normal value ranges of medical and laboratory tests updated preserved preserved 25 Drugs used in the trial and trial-related materials preserved preserved Shipping order preserved preserved preserved 26 Pharmacovigilance certificate of new batch number of test drug preserved preserved original 27 Supervisor's visit report preserved original 28 Signed informed consent letter preserved original 29 Original medical document preserved original 30 Case report form (completed, signed, dated) preserved copy preserved original 31 Serious adverse event report from investigator to sponsor preserved original preserved 32

Serious adverse event report from sponsor to the p>

Clinical trial preservation of documents investigator sponsor 38 test drug destruction certificate preservation preservation 39 completion of the trial subject code directory preservation preservation 40 audit certificates preservation of the original 41 final monitoring report preservation of the original 42 treatment allocation and blinding certificate preservation of the original 43 trial completion report (to the Ethics Committee of the State Food and Drug Administration) preservation of the original 44 summary report preservation preservation Original 4 Advances in medicine are based on research that, to some extent, ultimately relies on trials using humans as subjects. CHAPTER II PREPARATION AND NECESSARY CONDITIONS BEFORE CLINICAL TRIALS 5. In human medical research, consideration of the health of the subject should take precedence over scientific and societal interests.6. The primary purpose of human medical research is to improve methods of prevention, diagnosis, and treatment, and to increase the understanding of the etiology and pathogenesis of disease. Even the best proven preventive, diagnostic, and therapeutic methods should be continually tested for effectiveness, efficiency, feasibility, and quality through research. 7. Most preventive, diagnostic, and therapeutic treatments include risks and burdens in the current practice of medicine and medical research. Chapter 3: Safeguarding the rights and interests of subjects 8. Medical research should follow ethical standards that respect and protect the health and rights of all people. Some subject populations are vulnerable and require special protection. The special needs of the economically and medically disadvantaged must be recognized. Particular attention should be paid to subjects who are unable to give or refuse informed consent, subjects who may be coerced into giving informed consent, subjects who do not personally benefit from the research, and subjects undergoing concurrent treatments. 9. Researchers must be aware of the ethical, legal, and regulatory requirements for human subjects in their country, and comply with international requirements. No national ethical, legal or regulatory requirement shall be permitted to diminish or eliminate the protections afforded to subjects in this Declaration. 10. In medical research, it is the responsibility of the physician to protect the life and health of the subjects and to maintain their privacy and dignity. 11. Medical research on human subjects must be conducted in accordance with universally accepted scientific principles and be based on a thorough knowledge of the scientific literature and relevant information as well as on adequate laboratory and animal testing (if necessary). 12. Research that may affect the environment must be carried out with due care and respect for the rights of laboratory animals used in research. 13. The design and conduct of each human experiment should be clearly described in the protocol, which should be submitted to an ethical approval committee for review, comment, guidance, and, where appropriate, approval. This ethics committee must be independent of the investigator and sponsor and free from any other influence. The ethics committee should comply with the laws and systems of the country in which the trial is conducted. The committee is authorized to monitor the ongoing trial. It is the responsibility of the investigator to submit monitoring information to the committee, especially information on all serious adverse events. The investigator should also submit other information to the committee for approval, including information on funding, sponsors, institutions, and other potential conflicts of interest or incentives for subjects.