(January 17, 2004, the State food and drug administration released 5th) Chapter I General provisions article to strengthen the management of clinical trials of medical devices, maintain subject interests, ensure real, reliable clinical trial results, under the supervision and administration of medical devices Ordinance, these rules are formulated.
Article II implementation and supervision and inspection of medical device clinical trials should be in accordance with these provisions.
Article III clinical trials of medical devices in these rules refers to medical institution was eligible for clinical trials of medical devices (hereinafter referred to as medical institutions) on the applicant for registration of the medical device during normal conditions of use safety and effectiveness in accordance with the provisions for trial or validation process.
Medical device clinical trials designed to evaluate products has the expected safety and effectiveness.
The fourth clinical trials of medical devices shall comply with the Declaration of Helsinki of the World Medical Conference (annex 1) moral principle, justice, respect for human dignity, sought to make the participants maximize possible benefits and avoid injury.
Fifth article clinical trials of medical devices-medical device clinical trials and medical device clinical trials.
Medical device clinical trials is through clinical use to verify that the medical device theory principle, structure, performance, and other factors can guarantee safety and effectiveness.
Medical device clinical validation refers to validation through clinical use of the medical device and the main elements of structure, properties of products already on the market is substantially equivalent, had the same safety and effectiveness.
The scope of medical device clinical trials: the market has not yet appeared, safety and effectiveness of medical devices has yet to be confirmed.
Medical device clinical trials coverage: similar products already on the market, the safety and effectiveness of medical devices needs further confirmation.
Sixth article medical devices clinical test of premise conditions: (a) the products has review through of registered products standard or corresponding of national, and industry standard; (ii) the products has self-test report; (three) the products has State food drug supervision management sector with State quality technology supervision sector recognized of detection institutions issued of products type type test report, and conclusion for qualified; (four) by try products for first for implanted human of medical devices, should has the products of animal test report;
Other animal testing is required to confirm product safety on human clinical trials of products, should also be submitted to the animal testing report.
Chapter II subject to safeguard the rights of the seventh medical device clinical trial subjects were not allowed to charge a fee. Article eighth medical device clinical trial head or principal shall provide the participants or their legal representatives detailing the following: (a) the participants volunteered to participate in a clinical trial, right to exit at any stage clinical trials; (b) the subjects ' personal data confidential. Ethics Committee, and (food) drug supervision management sector, and implementation who can check out by try who of information, but shall not foreign disclosure its content; (three) medical devices clinical test programme, especially medical devices clinical test purpose, and process and term, and expected by try who may of benefit and may produced of risk; (four) medical devices clinical test during, medical institutions has obligations to by try who provides and the clinical test about of information information; (five) for by try products reasons caused by try who damage,
Subjects should be given appropriate compensation for implementers; matters relating to compensation in medical device clinical trials should be set out in the contract. Nineth participants fully understand the content of medical device clinical trials based on the gain of the informed consent form.
Informed agreed book except should including this provides eighth article by column the outside, also should including following content: (a) medical devices clinical test head signature and the signature date; (ii) by try who or its statutory agent of signature and the signature date; (three) medical institutions in medical devices clinical test in the found by try products expected yiwai of clinical effect, must on informed agreed book related content for modified, and suffered try who or its statutory agent again signature confirmed. Chapter III medical device clinical trial Protocol article tenth clinical trial programme is to clarify the test objectives, risk analysis, design, test methods and procedures, such as the content of the file.
Pilot programme should be established prior to the start of clinical trials of medical devices, medical device clinical trials must be conducted in accordance with the test plan.
11th medical device clinical trial protocol should be to maximize the protection of subjects and interests, the principles of safety and health first and foremost, should be responsible for clinical trials of medical institutions and implementation according to the prescribed form (annex 2), design, ethical committee approval to implement if modified, must be approved by the Ethics Committee.
12th has not yet appeared on the market of a third type of implant in vivo or using medical devices made of traditional Chinese medicine theory, to the technical review of the medical device clinical trial protocol should record.
13th have similar medical device adverse event listing, or medical devices efficacy is not clear, for the unification of the State food and Drug Administration clinical trials provisions of the programme.
To conduct such clinical trials of medical devices, implementers, medical institutions and clinical trials should implement unified clinical trial protocol requirements for staff.
14th medical device clinical trial protocols should be subject-specific product characteristics to determine the number, duration, clinical trials and clinical evaluation criteria, so that test results are statistically significant.
Medical device clinical trials should demonstrate the subject product the theory principle, basic structure and performance of the basic elements and test the safety and effectiveness of the product.
Medical device clinical validation programme should show that the test product and the main elements of structure, properties of products already on the market is substantially equivalent, had the same safety and effectiveness. 15th article medical devices clinical test programme should including following content: (a) clinical test of topics; (ii) clinical test of purpose, and background and content; (three) clinical evaluation standard; (four) clinical test of risk and benefit analysis; (five) clinical test personnel name, and positions, and titles and served sector; (six) General design, including success or failed of possibilities analysis; (seven) clinical test continued time and determine reason; (eight) each disease species clinical test cases number and determine reason; (nine)
Reasons for selecting object scope, number and select necessary settings in a control group; (j) therapeutic products should have a clear indication or scope (11) clinical performance evaluation methods and statistical treatments (12) side effect prediction and measures should be taken, (13) the informed consent of subjects (14) duties.
16th medical institutions and implementation of agreed clinical trial protocols are signed, and signed clinical trial contract.
17th medical device clinical trials should be more than two (including two) of medical institutions. Fourth chapter of medical device clinical trials implementers 18th implementer is responsible for initiating, implementing, organizing, financing and monitoring of clinical trials.
Implementation for the application for registration of the medical device unit. 19th article implementation who duties: (a) law select medical institutions; (ii) to medical institutions provides medical devices clinical test notes; (three) and medical institutions common design, and developed medical devices clinical test programme, signed both agreed of medical devices clinical test programme and the contract; (four) to medical institutions free provides by try products; (five) on medical devices clinical test personnel for training; (six) to medical institutions provides guarantees; (seven) occurred serious side effects should truthfully, and
Timely respectively to accepted the medical devices registered application of province, and autonomous regions, and municipalities (food) drug supervision management sector and national food drug supervision authority report, while to for the medical devices clinical test of other medical institutions informed; (eight) implementation who suspended medical devices clinical test Qian, should notification medical institutions, and Ethics Committee and accepted the medical devices registered application of province, and autonomous regions, and municipalities (food) drug supervision management sector and national food drug supervision authority, and description reason;
(I) the subject products cause harm to participants, implementers should be in medical device clinical trial subjects compensation contracts.
20th article medical devices clinical test notes should including following content: (a) by try products principle description, and indications, and function, and expected reached of using purpose, and using requirements description, and installation requirements description; (ii) by try products of technology index; (three) State food drug supervision management sector with State quality technology supervision sector recognized of detection institutions issued of by try products type type test report; (four) may produced of risk, recommended of prevention and the emergency processing method;
(E) possible security issues.
The fifth chapter of medical institutions and medical device clinical trial personnel article 21st medical device clinical trials of medical institutions, is through food and drug supervision and administration departments of the State Council in conjunction with the health Administrative Department under the State Council found that clinical trials of Al-Qaida.
22nd medical device clinical trial staff members shall meet the following requirements: (a) have undertaken this clinical expertise, qualification and competence; (b) familiar with the implementers to provide information and documentation relating to the clinical trial. 23rd article is responsible for medical devices clinical test of medical institutions and the clinical test personnel duties: (a) should familiar implementation who provides of about information, and familiar by try products of using; (ii) and implementation who common design, and developed clinical test programme, both signed clinical test programme and the contract; (three) truthfully to by try who description by try products of detailed situation, clinical test implementation Qian, must to by try who full of time consider whether participate in clinical test; (four) truthfully records by try products of side effects and the bad event,
And analysis reasons; occurred bad event and the serious side effects of, should truthfully, and timely respectively to accepted the medical devices registered application of province, and autonomous regions, and municipalities (food) drug supervision management sector and national food drug supervision authority report; occurred serious side effects, should in 24 hours within report; (five) in occurred side effects Shi, clinical test personnel should timely made clinical judge, take measures, protection by try who interests; necessary Shi, Ethics Committee right to immediately suspended clinical test;
(Six) clinical test suspended of, should notification by try who, and implementation who, and Ethics Committee and accepted the medical devices registered application of province, and autonomous regions, and municipalities (food) drug supervision management sector and national food drug supervision authority, and description reason; (seven) proposed clinical test report, and on report of correctness and the reliability is responsible for; (eight) on implementation who provides of information has confidential obligations. 24th medical institutions in charge of medical device clinical trials clinical trials under the auspices of professional and technical personnel should be identified as the head of the clinical trials.
Head of clinical trials shall meet the doctor in charge more than job titles. The sixth chapter, medical device clinical trials report upon completion of the 25th medical device clinical trials, take on clinical trials of medical institutions should be in medical device clinical trial protocol requirements and prescribed form (annex 3), issue a report.
Medical device clinical trials report should be signed and dated by the clinical trial personnel and undertake clinical trials clinical trials management in medical institutions signed, dated, and signed. 26th article medical devices clinical test report should including following content: (a) test of disease species, and cases total and cases of gender, and age, and group analysis, control group of set (necessary Shi); (ii) clinical test method; (three) by used of statistics method and the evaluation method; (four) clinical evaluation standard; (five) clinical test results; (six) clinical test conclusion; (seven) clinical test in the found of bad event and side effects and processing situation; (eight) clinical test effect analysis; (nine)
Indications, scope of application, contraindications and precautions (j) problems and suggestions for improvements. 27th medical device clinical trial data should be properly stored and managed. Medical institutions shall be preserved after the termination of clinical trial data to test for five years.
Implementation of clinical test data shall be saved to final product in ten years.
The seventh chapter supplementary articles article 28th by the State food and Drug Administration is responsible for the interpretation of these provisions.
29th these provisions come into force on April 1, 2004. Annexes: 1. the World Medical Assembly Declaration of Helsinki 2. medical device clinical trial protocols 3. medical device clinical trial report annex 1: World Medical Assembly Declaration of Helsinki ethical guidelines for medical research involving human subjects (by the 18th World Medical Assembly, Helsinki, Finland, June 1964. Revised: 29th World Medical Assembly, Tokyo, Japan, October 1975; the 35th World Medical Assembly, Venice, Italy, October 1983 41st World Medical Assembly, Hong Kong, September 1989 48th World Medical Assembly, Somerset West, South Africa, October 1996; the 52nd World Medical Assembly, Edinburgh, Scotland, October 2000), the preamble 1. the Declaration of Helsinki of the World Medical Assembly in drafting and Statement of ethical principles for medical research is the human body, to guide doctors and other participants in medical research involving human subjects.
Medical research involving human subjects includes research of the human body itself and the related data or data. 2. promotion and protection of human health is the responsibility of doctors.
Doctor's knowledge and morals in order to fulfil this responsibility. 3. the Declaration of Geneva of the World Medical Assembly "the health of the patient must be our priority," such a language binding for doctors.
International standards of medical ethics declared: "only when we meet the interests of patients, doctors before they are offered on the patient's physiological and psychological health measures that adversely affected."
4. medical progress is based on research, which to some extent is ultimately dependent upon the people as subjects of experiments.
5. in medical research involving human subjects, to subject health considerations should take precedence over scientific and social interest. 6. the primary purpose of medical research involving human subjects is to improve the prevention, diagnosis and treatment, and improve the understanding of the aetiology and pathogenesis of disease.
Even the best proven preventive, diagnostic and treatment methods through research should continue to test their effectiveness, efficiency, quality and feasibility.
7. in current medical practice and in medical research, prevention, diagnosis, and treatment of most risk and burden are included. 8. medical research should comply with ethical standards and respect to all people and to protect their health and rights. Some human subjects are vulnerable groups need special protection. Must identify the economy and health care on the special needs of disadvantaged people.
Paying particular attention to those who are unable to make informed consent or refuse informed consent of participants, may be made only under duress, informed consent of participants, and I personally have benefited from research subjects and subjects receiving concomitant treatment. 9. researchers must know the host country with regard to human research in ethical, legal and regulatory requirements, and to comply with international demands.
Ethics, laws and regulations in any country is not allowed to reduce or cancel the Declaration of the protection provided by the participants.
Second, the basic principles of medical research 10. in medical research, protect the life and health of participants, is the doctor's responsibility to maintain their privacy and dignity.
11. medical research involving human subjects must comply with generally accepted scientific principles, and based on the scientific literature and relevant information and comprehensive understanding and full laboratory tests and animal experiments (if necessary).
12. appropriate caution must be to implement the research could affect the environment, and to respect the rights of animals used in research. 13. each human trial design and implementation should be specified in the test instructions and approval test programmes should be submitted to the Ethics Committee for review, comment, guidance, under appropriate circumstances, for examination and approval. The Ethics Committee must be independent of the investigator and sponsor, and is not affected by any other effects. The Ethics Committee should comply with the laws and institutions of the State in which the test. Competence of the Committee to monitor ongoing trials. Researchers have a responsibility to submit monitoring information to the Committee, especially information on all serious adverse events.
Researchers also other information should be submitted to the Commission for approval, including those relating to funding, sponsors, research institutions and other potential conflicts of interest for the participants or encourage information.
14. research programme must have a description of ethical considerations, and shows that the programme is consistent with the principles stated in the Declaration. 15. medical research involving human subjects can only be used by qualified personnel and under the supervision and guidance of experts in clinical medicine.
Must always be medically qualified person responsible for the subjects, and not by the participants themselves are responsible for, even if the participants have informed consent to participate in the study. 16. before the start of each medical research involving human subjects, should first be carefully evaluated subjects or other persons than expected risks, burdens and benefits. This does not rule out healthy volunteers to participate in medical research.
All research should be publicly available. 17. the doctors foresee only when convinced that can fully test of time and be able to deal with the risk to the human studies.
If you find the risk outweighs any benefit or have reached positive conclusions and good doctors should stop when the results of research. 18. the importance of human medical research test purpose only over the participants own risk to and burden.
This is especially important when the subjects were healthy volunteers.
19. only human subjects of medical research to benefit from the results of the study can be carried out.
20. participants must be willing to participate in and fully understand the research. 21. it is important to always respect the rights of participants to protect their own.
As far as possible take measures to respect subjects privacy, and confidentiality of patient information and the subjects will be the body and spirit and personality of this impact is reduced to a minimum. 22. in any human studies should give each candidate tried to adequately inform the purpose of the study, methods, sources of funding, possible conflicts of interest, researchers study the subsidiary institutions, expected benefits and potential risks of the study and the discomfort that may occur. Should inform the subjects have the right to refuse to participate in the trial or at any time to exit the test and are not subjected to any reprisals. When participants understand this information, doctors should be given access to participant voluntary informed consent in written form.
If you can't get the written consent, access to the non-written consent must be formal records and witness the process. 23. when obtaining informed consent of research projects, should pay particular attention to subjects dependent relationship with doctor or may be forced to agree to attend.
In this case, informed consent obtained should be kept fully informed, but do not participate in this study and the subjects have no dependencies will come to. 24. no legal qualifications, physical or mental condition does not permit informed consent is given, or a minor research subjects, researchers must comply with the relevant laws, informed consent from its statutory Office of the Plenipotentiary.
Only the study to promote the health of the groups they represent essential meaning of existence, or legally eligible population when they were included in the study.
25. qualifications cannot be subjects, such as children, when you can actually make the decision to participate in research, researcher, unless the consent of the legally authorized representative must also ask for my permission. 26. some studies cannot consent from subjects, including clients or previously agreed to, and only when the subject physical/mental condition does not permit informed consent is a necessary feature in this population, the research can be conducted. Should be in the test set out in the programme participate in study participants cannot make informed consent for special reasons, and submitted to the Ethics Committee for review and approval.
Scenarios also indicate continuing studies as soon as possible from the subject himself or authorized agent to obtain informed consent. 27. the ethical responsibility of authors and publishers will have to bear. At the time of publication of research results, the researcher has a responsibility to ensure the accuracy of the results. As with positive and negative results should be published or otherwise publicly available. Publication should indicate sources of funding, research subsidiary and any possible conflict of interest.
Not in accordance with the principles of the Declaration published in the study cannot be accepted and published. Third, the additional principles for medical research combined with medical 28. doctors to combine medical research with medical measures, but only for the study has been shown to have potential for prevention, diagnosis and treatment of cases.
When you combine medical research with medical patients as research subjects have additional regulations to protect. 29. the benefits, risks, burdens and effectiveness of a new method should be and the best methods of prevention, diagnosis and treatment for comparison.
This does not rule out there is no effective prevention, diagnosis and treatment of existing research, placebo or no treatment as a control.
30. at the end of the study, each enrolled patient should be sure to get confirmed by the study of the most effective prevention, diagnosis and treatment. 31. the physician should fully inform patients to accept treatment in that part related to research.
Patients should refuse to participate in research must not affect the relationship between the patient and the doctor. 32. in the treatment of patients for which no proven prophylactic, diagnostic and therapeutic methods, or in the case of invalid, if doctors determine an unproven or new prophylactic, diagnostic and treatment methods are expected to save lives, restore health and to alleviate suffering, on the premise of obtain the informed consent of the patient, should not be restricted to using this method. In may cases, these methods should be used as the object of study, and there are plans to evaluate its safety and efficacy. Record new information received from all relevant cases and, where appropriate, be published.
And to follow the principles of the Declaration and other relevant.
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医疗器械临床试验方案
产品名称：
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承担临床试验的医疗机构：
Clinical trial category: head of clinical trials: (signature) date of =tbl/> before Note 1, medical device clinical trials, clinical trial protocols must be established. 2, clinical trial protocols by the medical establishment and implementation of common design, development.
Implementers and medical institutions signed the agreed programme of clinical trials, clinical trials contract and.
3, has not yet appeared on the market of the third implant or use medical devices made of traditional Chinese medicine theory, to the technical review of the medical device clinical trial protocol should record.
4, medical institutions and practitioners should work together to develop clinical trials for each disease duration, purpose to ensure tests are scheduled.
5 type of, clinical trials, clinical trials and clinical trials. =
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│副作用预测及应当采取的措施： │
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│临床性能的评价方法和统计处理方法： │
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医疗器械临床试验报告
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承担临床试验的医疗机构： Clinical trial category: head of clinical trials: (signature) date description =tbl/> 1, responsible for clinical trials of medical institutions should work in a serious and responsible attitude, fair and objective manner in accordance with clinical trial protocols for clinical trials
Check and fill out this report.
2, this report must be made by experienced attending physician in clinical trial more than clinical trials authorized signature.
3, clinical trial category divided into clinical trials and clinical trials. =
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