ClinicalTrial refers to any systematic study of drugs in human body (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions and/or absorption, distribution, metabolism and excretion of experimental drugs, so as to determine the efficacy and safety of experimental drugs.

Scheme, which describes the background, theoretical basis and purpose of the experiment, the design, method and organization of the experiment, including statistical considerations, the implementation and completion conditions of the experiment. The scheme must be signed and dated by the main researchers, research institutions and sponsors involved in the experiment.

Handbook for researchers (investigator? , sBrochure) is the clinical and non-clinical research data of experimental drugs in existing human research.

Informed consent refers to the process that subjects voluntarily confirm their consent to participate in clinical trials after informing them of all aspects of a trial, which must be proved by a signed and dated informed consent form.

InformedConsentForm is a written proof that each subject expresses his willingness to participate in an experiment. The researcher should explain the nature, purpose, possible benefits and risks of the experiment, alternative treatment methods and the rights and obligations of the subjects in accordance with the Helsinki Declaration, so that the subjects can fully understand and agree.

EthicsCommittee is an independent organization composed of medical professionals, legal experts and non-medical personnel. It is responsible for checking whether the clinical trial scheme and its annexes conform to ethics, and providing public guarantees to ensure the safety, health and rights of subjects are protected. Organizers and implementers of clinical trials should not interfere with or influence the composition and all activities of the Committee.

Researchers conduct clinical trials and are responsible for the quality of clinical trials and the safety and rights of subjects. Researchers must pass the qualification examination and have the professional expertise, qualifications and ability of clinical trials.

CoordinatingInvestigator, a researcher who is responsible for coordinating the work of researchers in multi-center clinical trials.

A company, institution or organization that initiates a clinical trial and is responsible for the initiation, management, finance and monitoring of the trial.

The supervisor, a person with relevant knowledge appointed by the applicant and responsible to the applicant, is responsible for monitoring and reporting the progress of the test and verifying the data.

Audit refers to the systematic inspection conducted by people who are not directly involved in the trial, so as to evaluate whether the implementation of the trial, the recording and analysis of data conform to the relevant laws and regulations of the trial plan, standard operating procedures and drug clinical trials.

Inspection: The drug supervision and administration department conducts a formal examination of the relevant documents, facilities, records and other aspects of clinical trials. The inspection can be carried out at the location of the pilot unit, the applicant or the contract research institution.

Case Report Form (CRF) refers to a document designed according to the provisions of the test plan to record the data of each subject during the test.

Research products, test drugs, control drugs or placebos used in clinical trials.

Adverse events refer to adverse medical events that occur after patients or clinical trial subjects receive drug treatment, but they are not necessarily related to treatment.

In serious adverse events, during the clinical trial, hospitalization, prolonged hospitalization, disability, work ability, life-threatening or death, congenital malformation and other events occurred.

Standard Operating Procedure (SOP) is a standard and detailed written procedure for effectively implementing and completing every work in clinical trials.

In clinical trials, the blind method/masking method makes one or more people unaware of the treatment distribution procedure of the subjects. Single blindness means that the subjects don't know, and double blindness means that the subjects, researchers, monitors or data analysts don't know the treatment allocation.

The Contract Research Organization (CRO) is an academic or commercial scientific institution. The sponsor may entrust him to perform certain tasks and work in clinical trials, and such entrustment must be stipulated in writing.

Article 69 The US Food and Drug Administration shall be responsible for the interpretation of this Code.

Article 70 This standard shall come into force on September 1 2003, and the "Management Standard for Drug Clinical Trials" issued by the State Administration of Pharmaceutical Products on September 1999, 2003 shall be abolished at the same time.

Appendix 1:

Helsinki Declaration of the World Medical Congress

Ethical principles of human medical research

Adopted: 18 World Medical Congress, Helsinki, Finland. 65438+June 0964

Revision: 29th World Medical Congress, Tokyo, Japan, 1975 65438+ 10.

The 35th World Medical Congress, Venice, Italy, 1983 10.

World Medical Congress, Hong Kong, 1989.

The 48th World Medical Congress, South Africa, 1996 65438+ 10.

The 52nd World Medical Congress was held in Edinburgh, Scotland, from 5 to 38 June 2000.

I. Introduction

1. The Helsinki Declaration drafted by the World Medical Congress is a statement on the ethical standards of human medical research, which is used to guide doctors and other people involved in human medical research. Human medical research includes the study of the human body itself and related data or materials.

It is the duty of doctors to promote and protect human health. The knowledge and morality of doctors is to fulfill this duty.

3. The Geneva Declaration of the World Medical Congress binds doctors with the language that "the health of patients must be our first consideration". "International Medical Ethics Standards" declares: "Only in the interests of patients, doctors can provide medical measures that may have adverse effects on patients' physiology and psychology".

The progress of medicine is based on research, and research ultimately depends on experiments with human subjects to some extent.

5. In human medical research, the consideration of subjects' health should take precedence over the interests of science and society.

6. The main purpose of human medical research is to improve the methods of prevention, diagnosis and treatment, and to improve the understanding of the etiology and pathogenesis of diseases. Even the best prevention, diagnosis and treatment methods that have been proved should be constantly tested for their effectiveness, efficiency, feasibility and quality through research.

7. In current medical practice and research, most prevention, diagnosis and treatment involve risks and burdens.

8. Medical research should follow ethical standards, respect all people and protect their health and rights. Some subjects are vulnerable groups and need special protection. We must recognize the special needs of people who are economically and medically disadvantaged. Special attention should be paid to those subjects who can't give informed consent or refuse to give informed consent, subjects who may give informed consent under coercion, subjects who can't benefit from the research and subjects who are receiving treatment at the same time.

9. Researchers must understand the ethical, legal and regulatory requirements of the host country for human research and meet international requirements. The ethics, laws and regulations of any country are not allowed to reduce or cancel the protection provided for subjects in this declaration.

Second, the basic principles of medical research

10. In medical research, the doctor's duty is to protect the life and health of the subjects and safeguard their privacy and dignity.

1 1. Human medical research must follow generally accepted scientific principles and be based on a comprehensive understanding of scientific literature and related materials and adequate laboratory and animal experiments (if necessary).

12. Research that may affect the environment must be conducted with caution, and the rights of experimental animals used for research should be respected.

13. The design and implementation of each human trial should be clearly stated in the trial plan, which should be submitted to the ethics review and approval committee for review, comment, guidance and review and approval when appropriate. The ethics committee must be independent of the researchers and organizers and not influenced by any other aspects. The ethics committee shall abide by the laws and regulations of the country where the experiment is conducted. The Committee has the right to supervise the ongoing experiment. It is the responsibility of researchers to submit monitoring data to the Committee, especially all serious adverse events data. Researchers should also submit other information for approval by the Committee, including information about funds, applicants, research institutions and other potential conflicts of interest or encouraging subjects.

14. The research plan must have an ethical explanation and show that the plan conforms to the principles stated in this statement.

15. Human medical research can only be conducted by qualified personnel under the guidance and supervision of clinical medical experts. The person in charge of the subject must always be a medically qualified person, but it is by no means the subject himself, even if the subject knowingly agrees to participate in the study.

16. Before each human medical research begins, the expected risk, burden and benefit ratio of the subjects or other personnel should be carefully evaluated. This does not exclude healthy subjects from participating in medical research. All research designs should be made public.

17. Doctors can only conduct this human research if they are sure that they can fully foresee the risks in the experiment and handle them well. If it is found that the risk exceeds the possible benefit or positive conclusions and favorable results are obtained, the doctor should stop the research.

18. Only when the importance of the experimental purpose exceeds the risk and burden of the subjects themselves can human medical research be carried out. This is especially important when the subjects are healthy volunteers.

19. Only when the subjects can benefit from the research results can medical research be carried out.

20. Subjects must participate voluntarily and have a full understanding of the research project.

2 1. The subjects' right to protect themselves must always be respected. Take measures as far as possible to respect the privacy of the subjects, keep the patient's information confidential, and minimize the impact on the subjects' body, spirit and personality.

22. In any human research, each candidate should be fully informed of the research purpose, methods, sources of funds, possible conflicts of interest, research subsidiary where the researcher belongs, expected benefits and potential risks of the research, and possible discomfort. The subjects should be informed that they have the right to refuse to participate in the experiment or withdraw from the experiment at any time without any retaliation. When confirming that the subject knows this information, the doctor should obtain the informed consent voluntarily given by the subject, preferably in writing. If written consent cannot be obtained, the process of obtaining non-written consent must be formally recorded and witnessed.

23. When obtaining the informed consent of the research project, special attention should be paid to whether the subjects and doctors are dependent or may be forced to agree to participate. In this case, the informed consent form should be obtained by a doctor who fully understands but does not participate in this study and is independent of the co-subjects.

24. For research subjects or minors who do not have legal qualifications and are not allowed to give informed consent due to their physical or mental conditions, researchers must obtain informed consent from their legal plenipotentiaries according to relevant laws. Only when the research is necessary to promote the health of the group they represent, or if it cannot be carried out among people with legal qualifications, can these people be included in the research.

25. When unqualified subjects, such as underage children, can actually make a decision to participate in the research, the researcher must obtain the consent of himself in addition to the consent of the legally authorized representative.

26. Some studies can't get the consent of the subjects, including the client's or previous consent. Only when the physical/mental condition of the subject does not allow informed consent is a necessary feature of this population can the study be carried out. The special reasons why subjects can't give informed consent should be made clear in the experimental scheme and submitted to the ethics Committee for examination and approval. The plan also needs to explain that the informed consent of the subject himself or his legally authorized agent should be obtained as soon as possible in continuing the study.

27. Both authors and publishers should bear moral responsibility. When publishing research results, researchers have the responsibility to ensure the accuracy of the results. Like positive results, negative results should be published or made public in other ways. The sources of funds, research affiliates and any possible conflicts of interest should be stated in the publication. Research reports that do not conform to the principles declared in this declaration cannot be accepted and published.

Third, the additional principle of combining medical research with medical treatment.

Doctors can combine medical research with medical measures, but only if the research has been proved to have potential preventive, diagnostic and therapeutic value. When medical research is combined with medical measures, patients as research objects should be protected by additional laws and regulations.

29. The benefits, risks, burdens and effectiveness of new methods should be compared with the best existing prevention, diagnosis and treatment methods. This does not rule out the use of placebo or no treatment as a control in studies with no effective prevention, diagnosis and treatment methods at present.

30. At the end of the study, each selected patient should ensure that the most effective prevention, diagnosis and treatment methods confirmed by the study can be obtained.

3 1. Doctors should fully inform patients which part of their treatment is related to the research. The patient's refusal to participate in the study should not affect the relationship between the patient and the doctor.

32. In the treatment of patients, if there is no proven prevention, diagnosis and treatment method, or the use is ineffective, if doctors judge that an unconfirmed or new prevention, diagnosis and treatment method is expected to save lives, restore health and alleviate pain, they should apply this method without restriction with the informed consent of patients. If possible, these methods should be taken as research objects and their safety and effectiveness should be evaluated in a planned way. Record the new information obtained from all relevant cases and publish it in due course. At the same time, we should follow other relevant principles of this declaration.

Appendix 2:

Clinical trial preservation file

I. Clinical trial preservation documents in the preparation stage of clinical trials Organizer 1 Researcher's Manual Preservation 2 Experimental scheme and its modification (signature) Preservation 3 Case report form (sample form) Preservation 4 Informed consent form Preservation 4 Original Preservation 5 Financial regulations Preservation 6 multi-party agreements (signed) (researcher, applicant, contract research organization) Save 7 Original approval documents of the Ethics Committee Save 8 Original list of members of the Ethics Committee Save 9 Original clinical trial application form Save 10 Original pre-clinical laboratory data Save 1 1 Original approval documents of the US Food and Drug Administration Save 12 Original researcher performance calendar and related documents Save 1 3 Original preservation of normal scope of laboratory examination related to clinical trials/original preservation of medical or laboratory operation quality control certificate/label preservation of experimental drugs/original clinical trial preservation file sponsored by researchers/experimental drugs and trials. Save the waybill of inspection related materials 17. Keep the original drug inspection certificate of test drug 18. Save the original blind breaking program of blind test 19. The original random table 20 is saved. Save the original audit report 2. Clinical Trial Preservation Documents in the Progress Stage of Clinical Trials Organizer 2 1 Update Researcher Manual Preservation 22 Update and Save Other Documents (Protocol, Case Report Form, Informed Consent Form, Written Notice) 23 New Investigator Resume Preservation 24 Update and Save the Normal Scope of Medical and Laboratory Examination. 25 Save the waybill of test drugs and test-related materials. 26. Save the drug inspection certificate of the new batch of experimental drugs. The inspector's visit report is saved. The signed informed consent form is saved. Original medical documents are saved. 30 The case report form (filled in, signed and dated) shall be copied and kept in the original. 3 1 serious adverse events Report shall be sent by the researcher to the applicant to keep the original, clinical trials and documents. Researcher sponsor 32 The sponsor saves the original serious adverse events report to the Ethics Committee of the Drug Administration 33 the interim or annual report 34 the original subject identification code table 35 the subject screening table and selection table 36 the trial drug registration form 37 the researcher's signature sample 37. After the clinical trial is completed, the clinical trial document is saved by the researcher sponsor 38. Preservation of the destruction certificate of the experimental drug 39. Save the test subject code directory and save 40. The original audit certificate is saved as 4 1. Save the final monitoring report 42. Save the certificate of treatment distribution and blindness prevention 43. Save the test completion report (to the Ethics Committee and the State Food and Drug Administration) 44. Save and save the summary report.