【正文】 to the source data file。 (two) the background data in clinical trials。 (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。 (two) the name of clinical trial institution。 (eight) clinical trial institution the facilities and conditions to meet the test review。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 trialsChapter one is the first chapterThe first is to strengthen the management of medical device clinical trials, the maintenance process for clinical trials of medical devices in rights and interests, and to guarantee the medical device clinical trials process specification, real results, science, reliable and traceable, according to the supervision and administration of Medical Devices Regulations formulated this specification.Article 2 within the territory of the people39。 (seven) researchers resume, professional expertise, skills, training and other documents to prove their qualifications。s 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 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 mittee.It is good to the health 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 mittee of the additional requirement. In clinical trials for their health is specially designed, and 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 mittee of the additional requirement. In clinical trials for 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 petence limit that the details of the clinical trials, including the known, it can be predicted 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.Twentysecond general consent shall include the following contents and description of matters: (a) the researchers name and relevant information。 (nine) subjects 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。 (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 mittee approval shall 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 again by the ethics mittee 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.Twentyfifth subjects have the right to withdraw from any stage of clinical trials and are not subject to any financial responsibility.The fourth chapter clinical trial programTwentysixth 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 other 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 initially recognized for their safety, according to the statistical requirements to determine the sample size to carry out the following clinical trial.Twentyeighth clinical trials protocol should include the following: (a) general information。 (nine) the provisions of adverse events and equipment defect report。 (four) the institution of clinical trial test sample size and distribution, with statistical analysis to For reason。 (IV), to suspend or terminate the test has been approved.Article 36 The Ethics Committee shall be of clinical trials of this clinical trial institution tracking supervision, it is found that the subjects39。 (four) the applicant from the ethics mittee approval, medical equipment is responsible to the clinical trial institutions and researchers to provide test, and determine the conditions of transport and storage conditions, storage time, period of validit