What is the name of the person who implements clinical trials and is responsible for the quality of clinical trials and the safety and rights and interests of the subjects?

Article 1 in order to ensure that the process of drug clinical trials standardized, the results of scientific and reliable, to protect the rights and interests of subjects and safeguard their safety, according to the "Chinese People's Republic of China *** and the State Drug Administration Law", "Chinese People's Republic of China *** and the implementation of the Drug Administration Law Regulations", with reference to the internationally recognized principles, the formulation of this specification. Article 2 Drug Clinical Trial Quality Management Specification is a standard provision for the whole process of clinical trials, including program design, organization and implementation, monitoring, auditing, recording, analysis and summary and reporting. Article 3 Where all phases of clinical trials, human bioavailability or bioequivalence test, must be carried out in accordance with these norms. Article IV all research with human subjects must comply with the World Medical Assembly Declaration of Helsinki (Appendix 1), namely, impartiality, respect for human dignity, and seek to maximize the benefit of subjects and avoid harm as far as possible. Article 5 must have a sound scientific basis for conducting clinical trials of drugs. Before conducting a human trial, the purpose of the trial and the problem to be solved must be carefully considered, and the expected benefits and risks to the subjects and public health should be weighed, and the expected benefits should outweigh the possible harm. The selection of clinical trial methods must comply with scientific and ethical requirements. Article 6 drugs for clinical trials shall be prepared and provided by the applicant. Before conducting clinical trials, the applicant must provide preclinical research information on the test drug, including the composition of the prescription, manufacturing process and quality inspection results. The preclinical information provided must be consistent with the requirements of the corresponding phase of clinical trials, but also should provide the test drug has been completed and other areas are undergoing clinical trials related to the effectiveness and safety information. Preparation of clinical trial drugs, should be in line with the "Drug Production Quality Management Standard". Article VII of the drug clinical trial organization's facilities and conditions should meet the needs of safe and effective clinical trials. All investigators shall have the professional expertise, qualifications and ability to undertake the clinical trial, and after training. Before the commencement of the clinical trial, the investigator and the applicant shall reach a written agreement on the trial program, the supervision, audit and standard operating procedures of the trial, as well as the division of responsibilities in the trial. Article 8 In the process of drug clinical trials, the individual rights and interests of the subjects must be adequately safeguarded, and the scientificity and reliability of the trial must be ensured. The rights and interests, safety and health of the subjects must take precedence over considerations of scientific and social interests. Ethics committees and informed consent are the main measures to safeguard the rights and interests of subjects. Article 9 In order to ensure the rights and interests of subjects in clinical trials, an independent ethics committee shall be established and filed with the State Food and Drug Administration. The Ethics Committee shall be composed of at least five members, who are engaged in medicine-related professionals, non-medicine professionals, legal experts and people from other organizations, and have members of different genders. The composition and work of the ethics committee shall not be influenced by any person involved in the trial. Article 10 The trial protocol shall be implemented only after the ethics committee has considered and agreed to it and signed an approval opinion. During the conduct of the trial, any modification of the trial protocol shall be approved by the Ethics Committee; any serious adverse events occurring in the trial shall be promptly reported to the Ethics Committee. Article 11 The Ethics Committee shall make a decision on the review of the clinical trial program by voting after discussion, and the members involved in the clinical trial shall recuse themselves. Experts who are not members may be invited to attend the meeting due to work needs, but they shall not vote. The ethics committee shall establish 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 items: (1) whether the qualifications, experience, and whether the investigators have sufficient time to participate in the clinical trial, and whether the staffing and equipment conditions meet the requirements of the trial; (2) whether the trial protocols have sufficiently taken into consideration the ethical principles, including the purpose of the study, the risks and benefits that the subjects and other people may suffer and the scientificity of the trial design; (3) whether the trial protocols have sufficiently taken into consideration the ethical principles, including the purpose of the study, the risks and benefits that the subjects and other people may suffer and the (iii) Whether the method of subject enrollment, the information provided to subjects (or their families, guardians or legal representatives) about the trial is complete and easy to understand, and whether the method of obtaining informed consent is appropriate; (iv) The treatment and/or insurance measures given to subjects in the event of damage or even death as a result of participation in the clinical trial; (v) Whether amendments proposed to the trial protocol are acceptable; and (v) Whether the amendments proposed to the trial protocol are acceptable; (vi) Regular review of the level of risk to the subjects in the conduct of the clinical trial. Article 13 The Ethics Committee shall hold a meeting in time 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 may be: (a) consent; (b) consent after making necessary amendments; (c) disagreement; (d) termination or suspension of the approved trial. Article 14 The researcher or his designated representative must explain to the subjects the details of the clinical trial: (1) the subjects should participate in the trial voluntarily and 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 will not be affected; (2) the subjects must be made to understand that the participation in the trial and the personal data in the trial are confidential. If necessary, the drug regulatory authority, the ethics committee or the applicant, according to the regulations, can access the information of the subjects participating in the trial; (c) the purpose of the trial, the process and duration of the trial, the examination operation, the possible benefits and risks expected by the subjects, and informs the subjects of the different groups to which they may be assigned in the trial; (d) subjects must be given sufficient time to consider whether or not they are willing to participate in the trial, and subjects who are incapable of expressing their consent should be informed of their consent by the drug regulatory authority. For subjects who are incapable of expressing consent, the above introduction and instructions should be provided to their legal representatives. The informed consent process shall be conducted in a language and text that the subject or legal representative understands, and the subject shall have access to information relevant to him/her at all times during the trial; (e) In the event of damage related to the trial, the subject shall have access to treatment and appropriate compensation. Article 15 Informed consent is obtained after a full and detailed explanation of the trial: (i) the subject or his/her legal representative signs and dates the informed consent form, and the researcher who carries out the informed consent process is also required to sign his/her name and date the informed consent form; (ii) for incapacitated subjects, if the ethics committee agrees in principle and the researcher believes that it is in his/her own interest for the subject to participate in the trial When the Ethics Committee agrees in principle and the investigator believes that it is in the interest of the subject to participate in the trial, these patients may also enter the trial, with the consent of their legal guardian, signed and dated; (iii) for children as subjects, the informed consent of their legal guardian must be obtained and signed, and when the child is able to make a decision to agree to participate in the study, the child's own consent must be obtained as well; and (iv) in case of emergency, where it is not possible to obtain informed consent from the person himself/herself or his/her lawful representative, for instance, in the following circumstances Lack of proven effective treatments, and the test drug is expected to save lives, restore health, or alleviate pain and suffering, can be considered as subjects, but the method of accepting these subjects needs to be clearly stated in the trial program and related documents, and prior consent of the Ethics Committee should be obtained; (e) If important new information involving the test drug is discovered, the informed consent form must be sent to the Ethics Committee for approval with a written modification and the consent of the subjects should be obtained again. The consent of the subjects shall be obtained again. Article XVI of the clinical trial should be developed before the start of the trial program, the program should be agreed and signed by the researcher and the applicant ****, reported to the Ethics Committee for approval and implementation. Article 17 The clinical trial program shall include the following: (1) the title of the trial; (2) the purpose of the trial, the background of the trial, the findings of clinical significance in the preclinical study and the results of the clinical trial related to the trial, the possible dangers and benefits known to the human body and the possibility of ethnographic differences of the test drug; (3) the name and address of the applicant, the place where the trial is to be conducted, and the name, qualifications and address of the researcher; (iv) the type of trial design, the method of randomization and the level of blinding; (v) the inclusion, exclusion and rejection criteria for subjects, the procedure for selecting subjects, and the method of subject allocation; (vi) the number of cases required to achieve the intended purpose of the trial according to the statistical principles; (vii) the formulations of the drugs to be used in the trial, their dosages, routes of administration, methods of administration, number of doses to be administered, the duration of the course of treatment, and provisions for the combined use of the drugs, as well as provisions for the packaging of the drugs; and (viii) the type of drug used in the trial, its dose, route of administration, method of administration, frequency of administration, course of treatment, and provisions for combining drugs. (viii) the items to be clinically and laboratory tested, the number of measurements and pharmacokinetic analysis, etc.; (ix) the registration and use records, delivery, distribution methods and storage conditions of the drugs for the trial; (x) clinical observation, follow-up and measures to ensure the compliance of the subjects; (xi) the criteria for discontinuing the clinical trial, and the provisions for the termination of the clinical trial; ( (xii) Criteria for evaluating efficacy, including the method of evaluating parameters, observation time, recording and analysis; (xiii) Procedures for coding of subjects, keeping of randomized numerical tables and case report forms; (xiv) Requirements for recording of adverse events and the reporting method of serious adverse events, treatment measures, the manner, time and regression of follow-up; (xv) Establishment and keeping of codes for medicines used in the trial, methods of unblinding and provisions for breaking blindness in emergencies; (xv) Provisions for establishing and keeping codes of medicines used in trials, methods of unblinding and provisions for breaking blindness in emergency situations; (xv) Provisions for the establishment and keeping of codes of drugs used in trials, methods of blinding and provisions for breaking blindness in emergency situations. (xv) establishment and preservation of drug codes for the trial, method of blinding and provisions for breaking the blind in case of emergencies; (xvi) statistical analysis plan, definition and selection of data sets for statistical analysis; (xvii) provisions for data management and data traceability; (xviii) quality control and quality assurance of the clinical trial; (xix) ethics related to the trial; (xx) the expected progress of the clinical trial and the date of completion of the clinical trial; (xxi) follow-up and medical measures after the trial is completed; (xxii) responsibilities and other relevant provisions assumed by all parties; and (xxviii) the responsibilities and other relevant provisions assumed by the parties concerned. responsibilities and other relevant provisions; (xxiii) references. Article 18 In the course of a clinical trial, if there is a genuine need, the trial protocol may be amended in accordance with the prescribed procedures. Article 19 is responsible for the clinical trial of the investigator shall have the following conditions: (a) in the medical institutions with appropriate professional and technical positions and qualifications to practice medicine; (b) with the test program in the required professional knowledge and experience; (c) the clinical trial method has a wealth of experience or can be experienced researchers in the unit in the academic guidance; (d) familiar with the applicant to provide and the clinical trial of information and literature; (e) references. (d) be familiar with the information and literature provided by the applicant in connection with the clinical trial; (e) have the right to dispose of the personnel involved in the trial and to use the equipment required for the trial. Article 20 The investigator must read and understand the content of the trial protocol in detail and strictly follow the protocol. Article 21 The investigator shall understand and be familiar with the nature, effects, efficacy and safety of the test drug (including information on preclinical studies of the drug), and shall also have access to all new information related to the drug discovered during the clinical trial. Article 22 The investigator must conduct the clinical trial in a medical institution with good medical facilities, laboratory equipment and staffing, which should have all the facilities to deal with emergencies in order to ensure the safety of the subjects. The results of laboratory tests shall be accurate and reliable. Article 23 The investigator shall obtain the consent of the medical institution or the competent unit in which he/she works to ensure that he/she has sufficient time to take charge of and complete the clinical trial within the period specified in the program. The investigator shall explain to all the staff participating in the clinical trial the information, regulations and duties related to the trial, and ensure that a sufficient number of subjects who are in accordance with the trial protocol are admitted to the clinical trial. Article 24 The investigator shall explain to the subjects the details about the trial as agreed by the ethics committee and obtain informed consent. Article 25 The investigator is responsible for making medical decisions related to the clinical trial and ensuring that the subjects receive appropriate treatment in the event of adverse events during the trial. Article 26 The investigator is obliged to take necessary measures to guarantee the safety of the subjects and record them. If a serious adverse event occurs in the course of the clinical trial, the investigator shall immediately take appropriate treatment measures for the subjects, and at the same time report to the drug regulatory and supervision department, the health administrative department, the applicant and the ethics committee, and sign and date the report. Article 27 The researcher shall ensure that the data are true, accurate, complete, timely and legally contained in the medical records and case report forms. Article 28 The investigator shall accept the supervision and inspection by the supervisor or auditor dispatched by the applicant and the audit and inspection by the drug regulatory authority to ensure the quality of the clinical trial. Article 29 The researcher shall agree with the applicant on the expenses related to the clinical trial and write them down in the contract. The researcher shall not charge the subjects for the expenses required for the drugs used in the trial in the course of the clinical trial. Upon completion of a clinical trial under Article 30, the investigator must write a summary report, sign and date it and send it to the applicant. Article 31 The researcher must notify the subjects, the applicant, the ethics committee and the drug regulatory authority of the discontinuation of a clinical trial, and state the reasons. Article 32 The applicant is responsible for initiating, applying for, organizing, supervising and auditing a clinical trial, and providing funds for the trial. The applicant shall, in accordance with national laws and regulations and other relevant provisions, submit applications for clinical trials to the State Food and Drug Administration, and may also entrust a contract research organization to carry out certain work and tasks in the clinical trial. Article 33 The applicant chooses the organization and the investigator of the clinical trial and recognizes their qualifications and conditions to ensure the completion of the trial. Article 34 The applicant shall provide the investigator's manual, which includes the chemical, pharmacological, toxicological, pharmacological and clinical (including previous and ongoing trials) information and data of the test drug. Article 35 of the applicant in the State Food and Drug Administration approval and obtain the approval of the Ethics Committee before organizing clinical trials in accordance with the program. Article 36 The applicant and the researcher*** shall design the clinical trial program together, stating the responsibilities and division of labor in the implementation of the program, data management, statistical analysis, reporting of results, publication of papers, etc. The applicant shall sign a mutually agreed trial program and contract. The applicant and the researcher*** shall sign the trial program and contract agreed by both parties. Article 37 The applicant shall provide the investigator with test drugs, standardized products, control drugs or placebos that are easily identifiable, correctly coded and affixed with special labels, and ensure that the quality is qualified. The test drugs shall be appropriately packaged and stored according to the needs of the test protocol. The applicant shall establish a management system and record system for the test drugs. Article 38 The applicant shall appoint qualified monitors who are acceptable to the investigator. Article 39 The applicant shall establish a quality control and quality assurance system for clinical trials and may organize audits of clinical trials to ensure quality. Article 40 the applicant and the investigator shall promptly study the occurrence of serious adverse events, to take the necessary measures to ensure the safety and rights and interests of the subjects, and timely report to the drug supervision and management department and the health administrative department, and at the same time to the other investigators involved in clinical trials of the same drug. Article 41 The applicant shall notify the investigator, the Ethics Committee and the State Food and Drug Administration before discontinuing a clinical trial, and state the reasons. Article 42 The applicant is responsible for submitting the summary report of the trial to the State Food and Drug Administration. Article 43 The applicant shall provide insurance for the subjects participating in the clinical trial, and bear the costs of treatment and corresponding financial compensation for the subjects who have suffered trial-related damage or death. The applicant shall provide legal and financial guarantees to the investigator, except for those caused by medical malpractice. Article 44 If the researcher fails to comply with the approved protocol or relevant laws and regulations in conducting the clinical trial, the applicant shall point out for correction; if the situation is serious or persistent, the researcher shall be terminated from participating in the clinical trial and report the case to the drug regulatory authorities. Article 45 The purpose of supervision is to ensure that the rights and interests of the subjects in the clinical trial are protected, that the data recorded and reported in the trial are accurate, complete and error-free, and that the trial complies with the approved program and relevant regulations. Article 46 Supervisors are the main contact person between applicants and investigators. The number of supervisors and the number of visits depends on the complexity of the clinical trial and the number of medical institutions involved in the trial. Supervisors should have appropriate medical, pharmacy or related professional qualifications, and after the necessary training, familiar with the relevant laws and regulations on drug management, familiar with the preclinical and clinical information about the test drug, as well as the clinical trial program and its related documents. Article 47 Supervisors shall follow the standard operating procedures and supervise the conduct of clinical trials in order to ensure that the clinical trials are executed according to the program. Specific content includes: (a) before the trial to confirm that the trial undertaking unit has appropriate conditions, including staffing and training, laboratory equipment is complete and in good working order, with a variety of test-related inspection conditions, estimated that there are a sufficient number of subjects, and the participating researchers are familiar with the requirements of the trial protocol; (b) in the course of the trial to supervise the implementation of the trial protocol of the investigator, to confirm that in the test (i) Obtained informed consent from all subjects prior to the trial, understood the enrollment rate of subjects and the progress status of the trial, and confirmed that the enrolled subjects were qualified; (ii) Confirmed that all data were recorded and reported correctly and completely, and that all case report forms were filled out correctly and were consistent with the original information. All errors or omissions were corrected or noted, signed and dated by the investigator. Dose changes, therapeutic alterations, comorbidities, intercurrent illnesses, missed visits, and missed tests should be identified and recorded for each subject. Verify that withdrawals and missed visits of enrolled subjects are accounted for in the case report form; (d) Confirm that all adverse events are recorded, and that serious adverse events are reported and recorded within the specified time; (e) Verify that trial medications are supplied, stored, dispensed, and withdrawn in accordance with the relevant regulations and recorded accordingly; (f) Assist the investigator with the necessary notifications and applications, and report the applicant's (f) Assisting the investigator in making necessary notifications and applications, and reporting to the applicant the data and results of the trial; (g) Recording clearly and truthfully the follow-up visits that the investigator failed to make, the tests that were not carried out, the tests that were not conducted, and the corrections that were made to the errors and omissions; (h) Making a written report to be delivered to the applicant after each visit, which shall state the date and time of the supervision, the name of the supervisor, and the findings of the supervision, and so on. Article 48 The medical record as the original documents of the clinical trial shall be completely preserved. The data in the case report form from the original documents and consistent with the original documents, any observations, test results should be timely, accurate, complete, standardized, true record in the medical record and correctly filled out to the case report form, and shall not be altered arbitrarily, due to filling in the error, and any corrections should be made to keep the original record clearly defensible, and signed by the corrector's name and time. Article 49 All kinds of laboratory data in the clinical trial shall be recorded or copies of the original report shall be pasted on the case report form, and data within the normal range shall also be specifically recorded. Data that deviates significantly or is outside the clinically acceptable range shall be verified. The unit of measurement used must be indicated for the test item. Article 50 To protect the privacy of the subject, the name of the subject should not appear on the case report form. The investigator shall confirm the identity of the subjects by their code and record it. Article 51 The content of the clinical trial summary report should be consistent with the requirements of the trial protocol, including: (a) the actual number of cases randomized into each group, cases that fell out and excluded and their reasons; (b) comparison of baseline characteristics between different groups to determine comparability; (c) statistical analysis and clinical significance analysis of all the efficacy evaluation indexes. Interpretation of statistical results shall focus on their clinical significance; (iv) safety evaluation shall have reasonable statistical analysis of clinical adverse events and laboratory indicators, and serious adverse events shall be described and evaluated in detail; (v) multi-center trials evaluating the efficacy of the trial shall take into account the differences that exist between the centers and their effects; and (vi) provide a brief overview and discussion of the efficacy and safety of the test drug and the relationship between risk and benefit. Article 52 All information in clinical trials shall be kept (Appendix 2) and managed in accordance with regulations. The investigator shall keep the clinical trial data until five years after the termination of the clinical trial. The applicant shall keep the clinical trial data until five years after the test drug is approved for marketing. Article 53 The purpose of data management is to incorporate trial data into reports in a prompt, complete and error-free manner. All the various steps involved in data management should be documented so that the quality of the data and the implementation of the trial can be checked. Appropriate procedures shall be used to guarantee the confidentiality of the database, and there shall be procedures for the maintenance and support of the computerized database. Article 54 The allocation of subjects in clinical trials must be carried out in accordance with the randomized allocation scheme determined by the trial design, and the treatment group code of each subject shall be kept as a blind base by the applicant and the investigator respectively. Blinded trials shall stipulate in the protocol the conditions for unblinding and the procedures for executing the unblinding, and be equipped with an emergency letter with the corresponding treatment code. In case of emergency, it is permissible to blind individual subjects to the treatment they have received on an emergency basis, provided that the reasons are stated in the case report form. Article 55 The process of statistical analysis of clinical trial data and the expression of its results must adopt standardized statistical methods. Biostatistics professionals shall be involved in all phases of the clinical trial. A statistical analysis plan shall be included in the clinical trial protocol and confirmed and refined before the formal statistical analysis. If interim analyses are required, the rationale and operational procedures should be explained. Confidence intervals should be considered in the evaluation of the therapeutic effect along with the results of hypothesis testing. The data set selected for statistical analysis should be described. For the omission, unused or redundant information must be explained, the statistical report of the clinical trial must be consistent with the clinical trial summary report. Article 56 of the clinical trial of drugs shall not be sold. Article 57 The applicant shall be responsible for the appropriate packaging and labeling of the medicines used in the clinical trial, and shall indicate that they are exclusively used in the clinical trial. In double-blind clinical trials, the test drug and the control drug or placebo shall be identical in appearance, odor, packaging, labeling and other characteristics. Records of the use of test drugs under Article 58 shall include information on quantity, shipment, delivery, acceptance, dispensing, recovery and destruction of the remaining drugs after application. Article 59 The use of test drugs shall be the responsibility of the investigator, who must ensure that all test drugs are used only for the subjects of the clinical trial, and their dosage and usage shall be in accordance with the trial protocol, and the remaining test drugs are returned to the applicant, with the above process under the responsibility of a person who is specially responsible for the process and recorded, and that the test drugs shall be managed by a person who is specially responsible for the process. The investigator shall not pass the test drug to any non-clinical trial participant. Article 60: The supply, use, storage and disposal of test medicines shall be subject to inspection by relevant personnel. Article 61 Both the applicant and the investigator shall fulfill their respective responsibilities and strictly follow the clinical trial protocols and adopt standard operating procedures in order to ensure the implementation of the quality control and quality assurance system of the clinical trial. Article 62 of the clinical trial about all observations and findings should be verified, in each stage of data processing must be quality control to ensure that the data is complete, accurate, true and reliable. Article 63 The drug supervision and management department and the applicant may commission an auditor to conduct a systematic inspection of the activities and documents related to the clinical trial in order to evaluate whether the trial is conducted in accordance with the trial protocols, standard operating procedures and the requirements of the relevant laws and regulations, and whether the trial data are recorded in a timely, truthful, accurate and complete manner. The inspection shall be performed by personnel not directly involved in the clinical trial. Article 64 The drug supervision and management department shall inspect the respective tasks and execution status of the investigator and the applicant in the implementation of the trial. The relevant information and documents (including medical records) of the medical institutions and laboratories participating in the clinical trial shall be subject to the inspection of the drug supervision and management department. Article 65 multi-center trial is conducted by a number of investigators according to the same test program in different locations and units at the same time the clinical trial. The centers start and end the trial at the same time. Multi-center trial by a principal investigator in charge, and as a clinical trial between the centers of the coordination of the investigator. Article 66 The planning and organization of multi-center trials shall take the following points into consideration: (1) the trial protocol shall be discussed and determined by the principal investigator of each center and the applicant***, and shall be implemented after approval by the Ethics Committee; (2) a meeting of the investigators shall be organized at the beginning of the clinical trial and at the midpoint of the trial; (3) clinical trials shall be conducted simultaneously at all the centers; (4) the sample sizes of the clinical trials at all the centers and their distribution among centers shall meet the requirements for statistical analysis; and (5) the sample size of the clinical trials at each center and the distribution among centers shall meet the requirements for statistical analysis. meet the requirements for statistical analysis; (v) ensure that trial medications are managed with the same procedures at different centers, including distribution and storage; (vi) train investigators participating in the trial according to the same trial protocol; (vii) establish standardized evaluation methods, and there should be uniform quality control for both laboratory and clinical evaluation methods used in the trial, and laboratory tests can also be conducted by the central laboratory; (viii) data information should be Centralized management and analysis, data transfer, management, verification and query procedures should be established; (ix) to ensure that the investigators of the test center to comply with the test protocol, including the termination of their participation in the trial in case of violation of the protocol. Article 67 multi-center trials should be based on the number of centers participating in the trial and the requirements of the trial, as well as the degree of knowledge of the drugs used in the trial to establish a management system, coordinating the investigators responsible for the implementation of the entire trial. Article 68 of the specification of the following terms mean: clinical trials (ClinicalTrial), refers to any systematic study of drugs in humans (patients or healthy volunteers), in order to confirm or reveal the role of the test drug, adverse reactions and / or test drug absorption, distribution, metabolism and excretion, with the aim of determining the efficacy of the test drug and safety. The trial protocol describes the background, theoretical basis and purpose of the trial, the design, methodology and organization of the trial, including statistical considerations, and the conditions under which the trial will be conducted and completed. The protocol must be signed and dated by the principal investigator(s), institution(s) and applicant(s) participating in the trial. Investigator's Brochure (Investigator's Brochure), is the clinical and non-clinical research information available on the trial drug at the time of the human study. Informed Consent (InformedConsent), the process by which a subject voluntarily confirms his or her agreement to participate in a clinical trial after being informed of all aspects of the trial, as evidenced by a signed and dated informed consent form. Informed Consent Form is a document in which each subject indicates that he or she is willing to participate in a trial. The researcher must explain to the subject the nature of the trial, the purpose of the trial, the possible benefits and risks, the alternative treatments available, and the rights and obligations of the subject in accordance with the Declaration of Helsinki, so that the subject fully understands and expresses his or her consent. EthicsCommittee, an independent organization composed of medical professionals, legal experts and non-medical personnel, whose duty is to verify the ethicality of clinical trial protocols and annexes and to provide public assurance that the safety, health and rights of subjects are protected. The composition and activities of the committee shall not be interfered with or influenced by the organization and conduct of the clinical trial. Investigator, the person who conducts the clinical trial and is responsible for the quality of the clinical trial and the safety and rights of the subjects. The investigator must be qualified, with clinical trial professional expertise, qualifications and capabilities. Coordinating Investigator (CoordinatingInvestigator), an investigator responsible for coordinating the work of investigators at each participating center in a multicenter clinical trial. Sponsor, a company, institution or organization that initiates a clinical trial and is responsible for the initiation, management, finance and monitoring of the trial. Monitor, a knowledgeable person appointed by and responsible to the sponsor to monitor and report on the conduct of the trial and verify data. Audit (Audit), refers to a systematic inspection carried out by personnel not directly involved in the trial, in order to evaluate whether the implementation of the trial, data recording and analysis is in line with the trial protocol, standard operating procedures and the relevant regulatory requirements of drug clinical trials. Inspection (Inspection), drug supervision and management of a clinical trial of relevant documents, facilities, records and other aspects of the official review, inspection can be in the trial unit, the applicant site or contract research organization site. CaseReportForm (CRF), a document designed to record data on each subject during the course of a trial, as specified in the trial protocol. Investigational Product, a test drug, control drug or placebo used in a clinical trial. AdverseEvent, an adverse medical event that occurs after a patient or clinical trial subject receives a drug, but is not necessarily causally related to the treatment. SeriousAdverseEvent, an event that occurs during the course of a clinical trial that requires hospitalization, prolongs hospitalization, disables, affects the ability to work, is life-threatening or fatal, or results in a congenital malformation. Standard Operating Procedure (SOP), a standardized and detailed written procedure for the effective implementation and completion of each task in a clinical trial. Blinding/Masking, a procedure in a clinical trial in which one or more parties are unaware of a subject's treatment assignment. Single-blinding means that the subject is unaware, and double-blinding means that neither the subject, investigator, monitor, or data analyst is aware of the treatment assignment. ContractResearchOrganiza-tion (CRO), an academic or commercial scientific organization. The applicant may entrust it to perform certain work and tasks in the clinical trial, and such entrustment must be stipulated in writing. Article 69 of this specification by the State Food and Drug Administration is responsible for interpretation. Article 70 of this specification since September 1, 2003 shall come into force, the former State Drug Administration on September 1, 1999 issued by the "Code of Practice for the Management of Clinical Trials of Drugs" shall be repealed at the same time.