医疗器械临床试验质量管理规范英文版

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1、State Food and Drug AdministrationNational Health and Family Planning CommissionNumber twenty-fifth has been state food and Drug Administration in the executive meeting of the, national health and Family Planning Commission, director of the committee meeting examined and adopted, is hereby promulgat

2、ed, since June 1, implementation.Director Bi JingquanDirector Li BinMarch 1, Standard for quality management of medical device clinical trialsChapter one is the first chapterThe first is to strengthen the management of medical device clinical trials, the maintenance process for clinical trials of me

3、dical devices in rights and interests, and to guarantee the medical device clinical trials process specification, real results, science, reliable and traceable, according to formulated this specification.Article 2 within the territory of the peoples Republic of China to carry out the clinical trial

4、of medical apparatus and instruments, shall comply with the specification. This specification covers the whole process of medical device clinical trials, including design of clinical trials, the implementation of, monitoring, verification, inspection, and data acquisition, record, and analyze the su

5、mmarizing and reporting.The third section of this specification referred to in the clinical trial of medical apparatus and instruments, refers to in the accreditation of medical instrument clinical trial institution, intends to apply for the registration of medical device in the normal conditions of

6、 use is safe and effective for confirmation or verification process.Fourth clinical trials of medical devices shall comply with the principles of law, ethical principles and scientific principles.Article 5 at or above the provincial level food and drug supervision and management departments responsi

7、ble for the supervision and management of medical device clinical trials. Health and family health department in charge, within its scope of functions and duties, strengthen the clinical trial of medical apparatus and instruments management. Food and drug supervision and management departments, heal

8、th and family health departments should establish the medical quality of clinical trial management information reporting mechanism, strengthen the class III medical devices, included in the national configuration of large medical equipment quality management objective of medical apparatus and instru

9、ments to carry out examination and approval of clinical trials and the corresponding clinical trial supervision and management of data communications.The second chapter is the preparation before clinical trialArticle 6 the clinical trial of medical apparatus and instruments shall have sufficient sci

10、entific basis and the clear purpose of the test, and weigh on expected and the public health benefit and risk, expected benefit should exceed the possible damage.Article 7 before clinical trials, the sponsor shall test done in preclinical studies of medical apparatus and instruments, including produ

11、ct design (structure, working principle and mechanism of action, is expected to use and scope of application, the applicable technical requirements and quality inspection, animal testing and risk analysis and results should be able to support the clinical trial. Quality inspection results including

12、self inspection report and a qualified inspection agency issued a year within the product registration inspection report.Prior to the eighth clinical trials, the applicant should prepare adequate testing of medical equipment. The development of the test with medical equipment shall meet the applicab

13、le requirements of the medical device quality management system.The nine clinical trials of medical devices shall be in two or more than two medical device clinical trial institution. Selected testing institutions shall be without qualification accreditation of medical instrument clinical trial inst

14、itution, and facilities and conditions shall meet the safety effectively clinical trial experience. Researchers should be able to bear the clinical trials of specialty, qualification and ability and trained. Qualification of medical instrument clinical trial institution identified management measure

15、s shall be formulated separately by the State Food and drug administration shall, jointly with the Ministry of health and Family Planning Commission.Article 10 before clinical trials, the sponsor and clinical trial institutions and researchers should test design, test quality control, test the divis

16、ion of responsibilities, sponsor to bear the costs associated with the clinical trial and test in may occur damage dealing with principles to reach a written agreement.Article 11 clinical trials should obtain consent of the clinical trial of medical apparatus and instruments institutional ethics com

17、mittee. Included in the need for clinical trials and approval of class III medical devices directory, should also be approved by the State Food and drug administration.Article 12 prior to clinical trials, the sponsor shall be to the location of provinces, autonomous regions, municipal food and drug

18、supervision and management departments for the record. Accept filing of food and drug supervision and administration department shall record the situation informed clinical trial institution is located at the same level of food and drug supervision and management departments, as well as health and f

19、amily health departments.The third chapter is the protection of the rights and interests of the subjectsThirteenth clinical trials of medical devices shall comply with the ethical standards set by the Helsinki declaration of the world medical assembly.The fourteenth ethical review and informed conse

20、nt are the main measures to protect the rights and interests of the subjects. The parties involved in clinical trials should assume the corresponding ethical responsibilities according to their respective responsibilities.Article 15 the sponsor should avoid undue influence or misleading to subjects,

21、 clinical trials and research and clinical trial participants or related party. Clinical trial institutions and researchers should avoid undue influence or misleading to subjects, the sponsor and other participants in clinical trials or interested parties.Sixteenth applicants, clinical trials and re

22、searchers should not exaggerate the compensation measures involved in clinical trials, to mislead the participants to participate in clinical trials.Seventeenth pre clinical trials, the applicant shall submit the following documents to the ethics committee by researchers and clinical trial instituti

23、on of medical instrument clinical trial management: (a) clinical trial program; (two) researchers manual; (three) written informed consent document and any other available to participants (; four) recruiting subjects and procedural documents to its propaganda; (five) the case report form text; (six)

24、 self inspection report and product registration inspection report; (seven) researchers resume, professional expertise, skills, training and other documents to prove their qualifications; (eight) clinical trial institution the facilities and conditions to meet the test review; (nine) with the develo

25、pment of medical devices in accordance with the relevant requirements of medical quality management system for the test statement; (ten) other documents related to ethical review. Ethics committee shall uphold the principles of ethics and science, review and supervise the implementation of clinical

26、trials.Eighteenth one of the following circumstances occur in the course of clinical trials, researchers should report to the clinical trial institution of medical instrument clinical trial management department, and the timely notification of the applicant, the ethics committee report: (a) serious

27、adverse events; (two) progress report, including a summary of safety and deviation reports; (three) for any amendment has been approved by the ethics committee of the file, does not affect the rights and interests of the subjects, safety and health, non substantive changes without prior reports or c

28、linical trials with the purpose or end not related, but afterwards shall notify in writing; (four) to suspend, terminate or suspend the request after the recovery of clinical trials (five;) affect the rights and interests of the subjects, from clinical trials or clinical trial safety and health scie

29、nce, including the deviation of request and report the deviation. For the protection of subjects Where a persons rights, security and health are not immediately reported in an emergency, it shall be reported in written form as soon as possible in accordance with the relevant provisions.Article 19 in

30、 the process of clinical trials, as amended clinical trial protocols and informed consent documents, request deviation, resume a paused clinical trials should be can continue to implement until it obtain the written approval of the ethics committee.It is good to the health article 20 should be avoid

31、ed as far as possible selection of minors, pregnant women, elderly, persons with mental obstacle in life critical patients as subjects, that really need to be selected, it shall abide by the ethics committee of the additional requirement. In clinical trials for their health is specially designed, an

32、d should be. article 20 should be avoided as far as possible selection of minors, pregnant women, elderly, persons with mental obstacle in life critical patients as subjects, that really need to be selected, it shall abide by the ethics committee of the additional requirement. In clinical trials for

33、 their health is specially designed, and should be.Article 21 in subjects in clinical trials, researchers should fully to subjects or no capacity for civil conduct, the guardian of the person of civil action competence limit that the details of the clinical trials, including the known, it can be pre

34、dicted the risk and possible adverse events. After full and detailed explanation by the subjects or their guardians in informed consent Book sign your name and date, researchers also need to in informed consent Book sign your name and date.Twenty-second general consent shall include the following co

35、ntents and description of matters: (a) the researchers name and relevant information; (two) the name of clinical trial institution; (three) the name of the trial, purpose, method, content; (four) test process, test period; (five) the sources of funds and the possible conflicts of interest; (six) the

36、 expected participants may benefit and known, risk can be foreseen and adverse events may occur; (seven) alternative treatment subjects can obtain the information and its potential benefits and risks; (eight) when needed, that subjects may be assigned to different groups of experiments; (nine) subje

37、cts participated in the experiment should be voluntary, and at any stage of the test has the right to withdraw without discrimination or revenge, the medical treatment and The rights and interests are not affected; (ten) told the subjects in the study of personal data is confidential, but the ethics

38、 committee, food and drug supervision and management departments, health departments or sponsor at work when necessary in accordance with the prescribed procedures, can refer to the subjects in the study of personal data; (eleven) as happened with the related test the hurt, the subjects could get tr

39、eatment and economic compensation; (twelve) the subjects can understand the related information during the test; (thirteen) free clinic project participants may be obtained during the test and other related subsidies. Informed consent shall be adopted by the subjects or guardians can understand the

40、language and text. Informed consent shall not contain any cause subjects to give up the legitimate rights and interests and exemption from clinical trial institutions and researchers, the sponsor or The agent shall be responsible for the content.Twenty-third obtain informed consent shall also meet t

41、he following requirements: (a) the subjects incapacitated, if the ethics committee agreed in principle, researchers believe that the subjects participating in a clinical trial with its own interests, can also enter clinical trials, but should try and marked by the Guardian Signature Date prior.; (tw

42、o) the subjects or their guardians without reading ability, in the process of knowledge should have a witness present, after a detailed explanation of the informed consent, witnesses read the informed consent and oral informed content, agreed to by the subjects or their care population head, witness

43、es in informed consent the book of signature and date, signature of witness and the researchers signature should be on the same day.; (three) minors as subjects, should obtain the consent of the guardian and signed informed consent Department informed consent, minors on whether to participate in tes

44、ting an intention, should also be their consent.; (IV) found relates to medical apparatus and instruments of important information or are expected to test the clinical impact of shall be of informed consent book content is modified, the modified informed consent by the ethics committee approval shal

45、l be by the test or its guardian re signature confirmation.Article 24 informed consent book shall be indicated in the formulation of date or revised versions of date. Such as informed consent in the test in the process of revision, revised version of the informed consent implement the book before ag

46、ain by the ethics committee agreed to. Revised edition of informed consent books clinical trial mechanism after, all before the end of the test process of the subjects were as affected by the shall signed the informed consent for the newly revised.Twenty-fifth subjects have the right to withdraw fro

47、m any stage of clinical trials and are not subject to any financial responsibility.The fourth chapter clinical trial programTwenty-sixth to carry out clinical trials of medical devices, the applicant should be in accordance with the categories of medical equipment testing, risk, intended use, and ot

48、her organizations to develop scientific and rational clinical trials program.Article 27 not inside and outside the approved the listing of new products, safety and performance has not been confirmed by medical, clinical trial design should first conduct a feasibility test for small samples, to be in

49、itially recognized for their safety, according to the statistical requirements to determine the sample size to carry out the following clinical trial.Twenty-eighth clinical trials protocol should include the following: (a) general information; (two) the background data in clinical trials; (three) th

50、e purpose of the experiment; (four) experimental design; (five) safety evaluation method; (six) effectiveness evaluation method; (seven) statistical considerations; (eight) the provisions for clinical trials program; (nine) the provisions of adverse events and equipment defect report; (ten) direct a

51、ccess to the source data file; (eleven) clinical trials involving ethical issues and instructions and informed consent document; (twelve) data processing and record keeping; (thirteen) financial and insurance; (fourteen) agreement. The test results were published part of the contents can be included

52、 in other related documents such as project researchers. Handbook of clinical trials Specific information about the organization, the results of the trial published agreement, finance and insurance can be expressed in the test plan, you can also make a separate agreement to be specified.Twenty-ninth

53、 multi center clinical trial by a number of researchers in the same test program in clinical trials in different period. The design and implementation of the test plan shall at least include the following contents: (a) the test plan and the clinical trial institutions and researchers to discuss iden

54、tified by the applicant organization, and a clear lead the unit of clinical trial institution for the coordination of researchers; (two) the researchers responsible for coordinating the work of coordination between the institution of clinical trial process of clinical trials, clinical trials in earl

55、y, middle and late organization researchers meeting, responsible for the implementation and the sponsor of the whole test together; (three) the institution of clinical trial the principle should be carried out over the same period and the end of clinical trials; (four) the institution of clinical tr

56、ial test sample size and distribution, with statistical analysis to For reason; (5) the sponsor and the clinical test units on experimental training plan and training records requirements; (VI) established test data transfer, management, query and verification procedure, especially clear requirement

57、s of the institution of clinical trial testing the data should be the lead unit centralized management and analysis; (7) after the end of the multi center clinical trials, each clinical trial institutions researchers should respectively issued a summary of clinical trials, together with a case repor

58、t table in accordance with the provisions of the audited over by coordinating research summary report.Fifth chapter ethics committee dutiesArticle 30 medical device clinical trial institution ethics committee shall be by at least five members, including medical professionals, medical professionals,

59、which should be the members of the different gender. Non medical specialty committee at least a legal worker and a name for the clinical trial institution other than the personnel. The ethics committee should be with the assessment and evaluation of the clinical trials of science, medicine and ethic

60、s, and other aspects of qualification or experience. All members should be familiar with ethical guidelines for the clinical trial of medical apparatus and instruments and relevant regulations and abide by the ethics committee of the constitution.Article 31 medical ethics committee shall comply with

61、 the provisions of the ethical standards and food and drug supervision and administration department and establish the corresponding working procedures and the formation of the file and work in accordance with the procedures perform their duties. The ethics committee independent to members of the re

62、searchers and the sponsor has the right to comment and participate in relevant test vote.Article 32 The Ethics Committee meeting shall be notified in advance, to participate in the review and the number of voting can not be less than five, make any decision should be by an ethics committee composed

63、by more than half of the members. Researchers can provide information on any aspect of the relevant test, but should not participate in the review, vote or comment. Ethics committee in the review of some special test, can invite experts in related fields.Thirty-third from the ethics committee shall

64、safeguard the rights and interests of the subjects of the perspective of strict consideration test scheme and related documents, and shall focus on the following: (a) the researchers qualifications, experience and whether there is sufficient time to participate in the clinical trial. (two) clinical

65、trial institution staffing and equipment conform to the test. (three) the subjects may suffer a degree of risk and benefit compared to the expected test is appropriate. (four) test program is fully considered the ethical principles, with scientific research purposes, including the appropriateness of subjects rights are protected, other persons may suffer the risk and protection method participants are science. (five) subjects were selected to test the method, the relevant information of the subjects or their guardians provided The informa