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 researchers 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 institution 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) 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 development 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 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 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 clinical 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 science, including the deviation of request and report the deviation. For the protection of subjects Where a person'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 committee.
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 committee 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 committee 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 competence 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.
Twenty-second general consent shall include the following contents 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 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) 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; (ten) told the subjects in the study of personal data is confidential, but the ethics 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 treatment 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 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 the 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.; (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 researcher's 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 testing 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 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 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 from any stage of clinical trials and are not subject to any financial responsibility. The fourth chapter clinical trial program
Twenty-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 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.
Twenty-eighth clinical trials protocol should include the following: (a) general information; (two) the background data in clinical trials; (three) the 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 access 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 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
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