【正文】 f the constitution.Article 31 medical ethics mittee shall ply with the provisions of the world medical assembly declaration of Helsinki 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 mittee independent to members of the researchers and the sponsor has the right to ment 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 mittee posed 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 ment. Ethics mittee in the review of some special test, can invite experts in related fields.Thirtythird from the ethics mittee shall 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 trial institution staffing and equipment conform to the test. (three) the subjects may suffer a degree of risk and benefit pared to the expected test is appropriate. (four) test program is fully considered the ethical principles, with scientific research purposes, including the appropriateness of subjects39。 (5) the sponsor and the clinical test units on experimental training plan and training records requirements。 (three) the institution of clinical trial the principle should be carried out over the same period and the end of clinical trials。 (fourteen) agreement. The test results were published part of the contents can be included 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.Twentyninth 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 identified by the applicant organization, and a clear lead the unit of clinical trial institution for the coordination of researchers。 (twelve) data processing and record keeping。 (ten) direct access to the source data file。 (eight) the provisions for clinical trials program。 (six) effectiveness evaluation method。 (four) experimental design。 (two) the background data in clinical trials。 (three) minors as subjects, should obtain the consent of the guardian and signed informed consent Department informed consent, minors on whether to participate in testing an intention, should also be their consent.。 (two) 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, witnesses in informed consent the book of signature and date, signature of witness and the researcher39。 (twelve) the subjects can understand the related information during the test。 (ten) told the subjects in the study of personal data is confidential, but the ethics mittee, 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。 (eight) when needed, that subjects may be assigned to different groups of experiments。 (six) the expected participants may benefit and known, risk can be foreseen and adverse events may occur。 (four) test process, test period。 (two) the name of clinical trial institution。) affect the rights and interests of the subjects, from clinical trials or clinical trial safety and health science, including the deviation of request and report the deviation. For the protection of subjects Where a person39。 (three) for any amendment has been approved by the ethics mittee of the file, does not affect the rights and interests of the subjects, safety and health, non substantive changes without prior reports or clinical trials with the purpose or end not related, but afterwards shall notify in writing。 (ten) other documents related to ethical review. Ethics mittee shall uphold the principles of ethics and science, review and supervise the implementation of clinical 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 mittee report: (a) serious adverse events。 (eight) clinical trial institution the facilities and conditions to meet the test review。 (six) self inspection report and product registration inspection report。 four) recruiting subjects and procedural documents to its propaganda。 (two) researchers manual。State Food and Drug AdministrationNational Health and Family Planning CommissionNumber twentyfifth medical equipment specification for the quality control of clinical trial of has been state food and Drug Administration in the executive meeting of the, national health and Family Planning Commission, director of the mittee meeting examined and adopted, is hereby promulgated, since June 1, 2016 implementation.Director Bi JingquanDirector Li BinMarch 1, 2016Standard for quality management of medical device clinical trial