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National policy

"Medical Device Clinical Trial Quality Management Regulations"

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No. 25

The "Quality Management Standards for Clinical Instruments Clinical Trials" has been reviewed and approved by the State Food and Drug Administration Administration Bureau and the National Health and Family Planning Commission Directors' Meeting. It is hereby promulgated and will be implemented as of June 1, 2016.


Director Bi Jingquan
Li Bin

March 1, 2016



Medical Device Clinical Trial Quality Management Practice
Chapter 1 General

The first is to strengthen the management of clinical trials of medical devices, maintain the rights and interests of subjects in the clinical trials of medical devices, and ensure the clinical trial process of medical devices. The results are true, scientific, reliable and traceable, according to the Regulations on the Supervision and Administration of Medical Devices. ", develop this specification.
Article 2 The clinical trials of medical devices conducted within the territory of the People's Republic of China shall follow this Code.
This specification covers the entire process of clinical trials of medical devices, including the design, implementation, monitoring, verification, and inspection of clinical trials, as well as the collection, recording, analysis, and reporting of data.
Article 3 The term "medical device clinical trial" as used in this specification refers to the process of confirming or verifying the safety and effectiveness of a medical device to be applied for registration under normal use conditions in a medical device clinical laboratory certified by the qualification. .
Article 4 Clinical trials of medical devices shall follow legal principles, ethical principles and scientific principles.
Article 5 The food and drug supervision and administration department at or above the provincial level is responsible for the supervision and management of clinical trials of medical devices.
The health and family planning department strengthens the management of clinical trials of medical devices within the scope of their duties.
The food and drug supervision and administration department and the health and family planning department shall establish a medical device clinical trial quality management information notification mechanism, strengthen the third type of medical devices, and include the medical devices for the allocation and management of large-scale medical equipment in the country to carry out clinical trial approval and corresponding clinical The information of the test supervision management data is reported.



Chapter II Preparation before clinical trials

Article 6 The clinical trial of medical devices shall have sufficient scientific evidence and clear test objectives, and weigh the benefits and risks of the expected health of the subjects and the public. The expected benefits shall exceed the possible damage.
Article 7 Before the clinical trial, the sponsor shall complete the preclinical research of the medical device for testing, including product design (structural composition, working principle and mechanism of action, intended use and scope of application, applicable technical requirements) and quality inspection, animal testing. And risk analysis, etc., and the results should be able to support the clinical trial. The quality inspection results include the self-inspection report and the qualified product inspection inspection report issued within one year issued by a qualified inspection agency.
Article 8 Before the clinical trial, the sponsor shall prepare sufficient medical equipment for testing. The development of medical devices for testing shall comply with the relevant requirements of the applicable medical device quality management system.
Article 9 Medical device clinical trials shall be conducted in two or more clinical trial institutions for medical devices.
The selected testing institution shall be a medical device clinical testing institution certified by qualification, and the facilities and conditions shall meet the needs of safe and effective clinical trials. The investigator should have the expertise, qualifications, and competencies to undertake the clinical trial and be trained.
The administrative measures for the qualification certification of medical device clinical trial institutions shall be formulated separately by the State Food and Drug Administration and the National Health and Family Planning Commission.
Article 10 Before the clinical trial, the sponsor and the clinical trial institution and the investigator shall reach a conclusion on the design of the trial, the quality control of the trial, the division of responsibilities in the trial, the costs associated with the clinical trial undertaken by the sponsor, and the principles of injury treatment that may occur during the trial. Written agreement.
Article 11 Clinical trials shall be approved by the ethics committee of the clinical trial organization of medical devices. The list of the third category of medical devices that need to be approved for clinical trials shall also be approved by the State Food and Drug Administration.
Article 12 Before the clinical trial, the sponsor shall file with the food and drug supervision and administration department of the local province, autonomous region or municipality directly under the Central Government for the record.
The food and drug supervision and administration department that accepts the record shall notify the food and drug supervision and administration department at the same level as the location of the clinical trial institution and the competent department of health and family planning.


Chapter III Subject Rights Protection

Article 13 Clinical trials of medical devices shall follow the ethical guidelines established by the Helsinki Declaration of the World Medical Congress.
Article 14 Ethical review and informed consent are the main measures to protect the rights and interests of the subjects.
The parties involved in the clinical trial shall bear corresponding ethical responsibilities in accordance with their respective duties in the trial.
Article 15 The sponsor shall avoid undue influence or misleading of clinical trial participants or related parties such as subjects, clinical trial institutions and researchers.
Clinical trial institutions and investigators should avoid undue influence or misleading of clinical trial participants or related parties such as subjects and sponsors.
Article 16 Sponsors, clinical trial institutions and researchers shall not exaggerate the compensation measures involved in clinical trials and mislead subjects to participate in clinical trials.
Article 17 Before the clinical trial, the sponsor shall submit the following documents to the ethics committee through the medical device clinical trial management department of the researcher and the clinical trial institution:
(1) clinical trial plan;
(2) The researcher's manual;
(3) the text of the informed consent form and any other written materials provided to the subject;
(iv) procedural documents for recruiting and advertised to the subject;
(5) The text of the case report form;
(6) Self-inspection report and product registration inspection report;
(7) The resume, professional expertise, ability, training and other documents that can prove his or her qualifications;
(8) The facilities and conditions of the clinical trial institution can satisfy the review of the trial;
(9) The formulation of the medical device for testing conforms to the relevant requirements of the relevant medical device quality management system;
(10) Other documents related to ethical review.
The ethics committee should uphold the principles of ethics and science to review and supervise the implementation of clinical trials.
Article 18 In the case of any of the following conditions during the clinical trial, the investigator shall promptly report to the clinical trial management department of the clinical trial institution, and notify the sponsor and the report ethics committee in time:
(1) Serious adverse events;
(2) Progress report, including safety summary and deviation report;
(3) Any amendments to the approved documents of the ethics committee shall not affect the rights, safety and health of the subjects, or insubstantial changes not related to the purpose or end point of the clinical trial, without prior reporting, but shall be notified in writing afterwards;
(4) requesting the restoration of clinical trials after suspension, termination or suspension;
(5) Scientific trial protocol deviations affecting the subject's rights, safety and health or clinical trials, including request deviation and reporting deviation.
In order to protect the rights, safety and health of the subjects, if the deviation occurred in an emergency situation cannot be reported in time, it shall be reported in writing as soon as possible in accordance with relevant regulations.
Article 19 In the course of clinical trials, if the revision of clinical trial plan and informed consent documents, requests for deviation, and restoration of suspended clinical trials, the written approval of the ethics committee shall be followed.
Article 20: It is necessary to avoid the selection of minors, pregnant women, the elderly, mentally handicapped persons, patients in critical situations such as life as subjects; if it is necessary to select, it shall comply with the relevant additional requirements put forward by the ethics committee. The test is specifically designed for its health and should be beneficial to its health.
Article 21 Before the subject participates in the clinical trial, the investigator shall fully explain the details of the clinical trial to the subject or the guardian of the person without civil capacity or the person with limited capacity for civil conduct, including known and foreseeable Risks and possible adverse events, etc. After full and detailed explanation, the subject or his or her guardian signs the name and date on the informed consent form, and the investigator also signs the name and date on the informed consent form.
Article 22 The informed consent form shall generally include the following contents and a description of the matters:
(1) the name of the researcher and related information;
(2) the name of the clinical trial institution;
(3) The name, purpose, method and content of the test;
(4) The test process and time limit;
(5) The source of funds for the trial and possible conflicts of interest;
(vi) possible benefits to the subject and known, foreseeable risks and possible adverse events;
(7) Information on alternative treatment methods available to the subject and their potential benefits and risks;
(v) when needed, indicating that the subject may be assigned to a different group of trials;
(9) Subjects participating in the trial shall be voluntary and shall have the right to withdraw at any stage of the trial without discrimination or retaliation, and their medical treatment and rights shall not be affected;
(10) The personal data that informs the participants to participate in the trial is confidential, but the ethics committee, the food and drug supervision and administration department, the health and family planning authority or the sponsor can refer to the personal data of the participants participating in the trial according to the prescribed procedures when necessary for work;
(11) Subjects may receive treatment and financial compensation in the event of injury associated with the test;
(12) Subjects may keep abreast of the information related to them during the trial;
(13) Free medical treatment items and other related subsidies that the subject may receive during the trial.
Informed consent should be in a language and script that the subject or guardian can understand. Informed consent should not contain content that would cause the subject to waive his or her legal rights and to waive the responsibility of the clinical trial institution and the investigator, sponsor, or agent.
Article 23 The obtaining of informed consent shall also meet the following requirements:
(1) For a non-behaving subject, if the ethics committee agrees in principle and the investigator believes that the subject participates in the clinical trial in its own interest, it can also enter the clinical trial, but the signature should be signed and signed by the guardian before the trial. Bright date
(2) When the subject or his or her guardian has no reading ability, a witness shall be present in the informed process. After detailed explanation of the informed consent, the witness reads the informed consent and the oral informed content is consistent with the subject or After the guardian’s head agrees, the witness signs and signs the informed consent form, and the witness’s signature and the investigator’s signature should be on the same day;
(3) A minor as a subject shall obtain the informed consent of his guardian and sign an informed consent form. If the minor can express his or her intention to participate in the trial, he shall also obtain his or her consent;
(4) If the important information related to the medical device for trial or the clinical impact other than the expected clinical impact is found, the relevant content of the informed consent form shall be revised. After the revised informed consent form is approved by the ethics committee, it shall be re-reviewed by the subject or his guardian. Signature confirmation.
Article 24 The informed consent form shall indicate the date of the enactment or the date of the revised version. If the informed consent form has been revised during the trial, the revised informed consent form must be approved by the ethics committee again. After the revised informed consent form is reported to the clinical trial facility, all subjects who have not completed the trial procedure should sign a newly revised informed consent if they are affected.
Article 25 Subjects have the right to withdraw at any stage of the clinical trial and do not bear any financial responsibility.
Chapter IV Clinical Trial Program
Article 26 To carry out clinical trials of medical devices, the sponsor shall organize scientific and reasonable clinical trial programs according to the types, risks and intended uses of the medical devices for testing.
Article 27 For new products that have not been approved for listing at home and abroad, the safety and performance have not been confirmed by medical treatment. The clinical trial plan should be designed with a small sample feasibility test. After the initial confirmation of its safety, according to the statistics The study requires the determination of the sample size for subsequent clinical trials.
Article 28 The clinical trial plan for medical devices shall include the following contents:
(1) General information;
(2) Background information on clinical trials;
(3) The purpose of the test;
(4) Experimental design;
(5) Safety evaluation methods;
(6) Method of effectiveness evaluation;
(7) Statistical considerations;
(8) Provisions for amendments to clinical trial protocols;
(9) Provisions on reports of adverse events and device defects;
(10) Direct access to source data and documents;
(11) Ethical issues and explanations involved in clinical trials and the text of informed consent;
(12) Data processing and record keeping;
(13) Finance and insurance;
(14) The test results are published.
Some of the above may be included in other relevant documents of the program such as the researcher's manual. The specific information of the clinical trial institution, the publication of the test results, financial and insurance can be expressed in the test plan, or an additional agreement can be made.
Article 29 Multi-center clinical trials are conducted by multiple investigators in the same clinical trials in different clinical trial institutions. The design and implementation of its test plan should include at least the following:
(1) The trial protocol is formulated by the sponsor organization and discussed jointly by the clinical trial institutions and researchers, and the investigator of the clinical trial institution of the lead unit is the coordinating researcher;
(2) Coordinating the researcher to be responsible for the coordination of work among the clinical trial institutions during the clinical trial, organizing the investigator meeting in the pre-, post-, and post-clinical trials, and cooperating with the sponsor for the implementation of the entire trial;
(3) In principle, each clinical trial institution shall initiate and end clinical trials at the same time;
(4) Reasons for the sample size and distribution of each clinical trial institution and the requirements for statistical analysis;
(5) The requirements of the sponsors and clinical trial institutions for the planning and training records of the trial training;
(6) Establish procedures for transmission, management, verification and inquiry of test data, and specifically require that the relevant data of the trial data of each clinical trial institution should be managed and analyzed centrally by the lead unit;
(7) After the end of the multi-center clinical trial, the researchers of each clinical trial institution shall issue a summary of the clinical trial, together with the medical report form, and submit it to the coordinating researcher to complete the summary report.

Chapter IV Clinical Trial Program

Article 26 To carry out clinical trials of medical devices, the sponsor shall organize scientific and reasonable clinical trial programs according to the types, risks and intended uses of the medical devices for testing.
Article 27 For new products that have not been approved for listing at home and abroad, the safety and performance have not been confirmed by medical treatment. The clinical trial plan should be designed with a small sample feasibility test. After the initial confirmation of its safety, according to the statistics The study requires the determination of the sample size for subsequent clinical trials.
Article 28 The clinical trial plan for medical devices shall include the following contents:
(1) General information;
(2) Background information on clinical trials;
(3) The purpose of the test;
(4) Experimental design;
(5) Safety evaluation methods;
(6) Method of effectiveness evaluation;
(7) Statistical considerations;
(8) Provisions for amendments to clinical trial protocols;
(9) Provisions on reports of adverse events and device defects;
(10) Direct access to source data and documents;
(11) Ethical issues and explanations involved in clinical trials and the text of informed consent;
(12) Data processing and record keeping;
(13) Finance and insurance;
(14) The test results are published.
Some of the above may be included in other relevant documents of the program such as the researcher's manual. The specific information of the clinical trial institution, the publication of the test results, financial and insurance can be expressed in the test plan, or an additional agreement can be made.
Article 29 Multi-center clinical trials are conducted by multiple investigators in the same clinical trials in different clinical trial institutions. The design and implementation of its test plan should include at least the following:
(1) The trial protocol is formulated by the sponsor organization and discussed jointly by the clinical trial institutions and researchers, and the investigator of the clinical trial institution of the lead unit is the coordinating researcher;
(2) Coordinating the researcher to be responsible for the coordination of work among the clinical trial institutions during the clinical trial, organizing the investigator meeting in the pre-, post-, and post-clinical trials, and cooperating with the sponsor for the implementation of the entire trial;
(3) In principle, each clinical trial institution shall initiate and end clinical trials at the same time;
(4) Reasons for the sample size and distribution of each clinical trial institution and the requirements for statistical analysis;
(5) The requirements of the sponsors and clinical trial institutions for the planning and training records of the trial training;
(6) Establish procedures for transmission, management, verification and inquiry of test data, and specifically require that the relevant data of the trial data of each clinical trial institution should be managed and analyzed centrally by the lead unit;
(7) After the end of the multi-center clinical trial, the researchers of each clinical trial institution shall issue a summary of the clinical trial, together with the medical report form, and submit it to the coordinating researcher to complete the summary report.


Chapter V Ethics Committee Responsibilities

Article 30 The ethics committee of a medical device clinical trial institution shall consist of at least five members, including medical professionals and non-medical professionals, who shall have members of different genders. At least one of the non-medical professional members is a legal worker and one is a person outside the clinical trial institution. Members of the Ethics Committee shall have qualifications or experience in assessing and evaluating the scientific, medical, and ethical aspects of the clinical trial. All members should be familiar with the ethical guidelines and relevant regulations for clinical trials of medical devices and comply with the ethics committee's charter.
Article 31 The Medical Device Ethics Committee shall abide by the ethical guidelines of the Helsinki Declaration of the World Medical Congress and the provisions of the food and drug supervision and administration department, establish corresponding working procedures and form documents, and perform duties in accordance with the working procedures.
Members of the ethics committee independent of the investigator and sponsor have the right to express their opinions and participate in the voting on the trial.
Article 32 The ethics committee shall convene a meeting in advance, and the number of participants in the review and voting shall not be less than five. Any decision shall be passed by more than half of the members of the ethics committee.
The investigator can provide information about any aspect of the trial, but should not participate in the review, vote, or comment.
The ethics committee may invite experts from relevant fields to participate in the review of certain special trials.
Article 33 The ethics committee shall strictly consider the test plan and related documents from the perspective of safeguarding the rights and interests of the subjects, and shall focus on the following contents:
(1) The qualifications, experience, and sufficient time of the investigator to participate in the clinical trial.
(2) Whether the staffing of the clinical testing institution and the equipment conditions meet the test requirements.
(3) The degree of risk that the subject may be exposed to is appropriate compared to the expected benefit of the trial.
(4) Whether the experimental plan fully considers the ethical principles and whether it is scientific, including whether the research purpose is appropriate, whether the rights of the subjects are protected, the protection of other people may be at risk, and whether the method of selecting subjects is scientific.
(5) The method of enrolling the subject, whether the information provided to the subject or his or her guardian about the test is complete, whether the subject understands, and whether the method of obtaining the informed consent is appropriate; if necessary, the ethics committee should organize The test population representative tested the comprehensibility of the data and assessed whether the informed consent was appropriate. The results of the assessment should be documented and saved to 10 years after the end of the clinical trial.
(6) Whether the treatment and insurance measures given are sufficient if the subject has suffered injury or death related to the clinical trial.
(7) Whether the amendments proposed to the test plan are acceptable.
(8) Whether it is possible to periodically analyze and evaluate the possible hazards to the subjects during the clinical trial.
(9) Deviations from the test protocol may affect the subject's rights, safety and health, or affect the scientific and completeness of the test, and whether it is acceptable.
Article 34 The ethical review of a multi-center clinical trial shall be undertaken by the ethics committee of the lead unit to establish a collaborative review process to ensure consistency and timeliness of the review.
The ethics committee of the lead unit shall be responsible for reviewing the ethical rationality and scientificity of the trial protocol before the start of the trial in each clinical trial institution. The ethics committees of other clinical trial institutions participating in the trial may adopt the conference review on the premise of accepting the review opinions of the ethics committee of the lead unit. Or the method of document review, review the feasibility of the trial in this clinical trial institution, including the qualifications and experience of the researcher, equipment and conditions, etc., generally no longer modify the design of the trial plan, but has the right not to approve Tested in its clinical trial facility.
Article 35 After receiving an application for a clinical trial of medical devices, the ethics committee shall convene a meeting to review and discuss, issue written opinions and seals, and attach a list of personnel attending the meeting, the profession, and the signature of the person. The opinions of the ethics committee can be:
(1) agree;
(2) agreeing with the necessary modifications;
(3) disagree;
(4) Suspension or termination of the approved test.
Article 36 The ethics committee shall follow up and supervise the clinical trials of the clinical trial institution and find that the subject's rights and interests cannot be guaranteed. The clinical trial may be suspended or terminated at any time in writing.
Suspended clinical trials may not be resumed without the consent of the ethics committee.
Article 37 The ethics committee shall retain all relevant records until at least 10 years after the completion of the clinical trial.


Chapter VI Sponsor's Responsibilities

Article 38 The sponsor is responsible for initiating, applying, organizing, and supervising clinical trials, and is responsible for the authenticity and reliability of clinical trials. The sponsor is usually a medical device manufacturer. Where the sponsor is an overseas institution, an agent shall be appointed within the territory of China.
Article 39 The sponsor is responsible for organizing the development and revision of the researcher's manual, clinical trial protocol, informed consent form, case report form, relevant standard operating procedures and other relevant documents, and is responsible for organizing the training necessary for conducting clinical trials.
Article 40 The sponsor shall select the testing institution and its researcher in the medical device clinical testing institution certified by the qualification according to the characteristics of the medical device for testing. The sponsor should provide the clinical investigator and the investigator with the most up-to-date investigator's manual and other relevant documents before deciding to sign a clinical trial agreement with the clinical trial facility for the decision to accept the clinical trial.
Article 41 The researcher's manual shall include the following main contents:
(1) Basic information of the sponsor and the researcher;
(2) A summary description of the medical device for testing;
(3) Supporting the summary and evaluation of the intended use of the medical device for trial use and the rationale for the design of the clinical trial;
(4) A statement that the manufacture of the medical device for testing conforms to the requirements of the applicable medical device quality management system.
Article 42 The sponsor shall not exaggerate the mechanism and efficacy of the medical device for testing in the formulation of the clinical trial program.
Article 43 In the course of clinical trials, when the sponsor obtains important information affecting the clinical trial, the researcher's manual and related documents shall be revised in time, and submitted to the ethics committee for review by the medical device clinical trial management department of the clinical trial institution. agree.
Article 44 The sponsor shall conclude a written agreement with the clinical trial institution and the investigator on the following matters:
(1) Implement clinical trials in accordance with relevant laws and regulations and clinical trial programs, and accept audits, verifications and inspections;
(2) Following the data recording and reporting procedures;
(3) retaining the basic documents related to the trial no less than the statutory time until the sponsor notifies the clinical trial institution and the investigator that the document is no longer needed;
(4) After the sponsor has been approved by the ethics committee, it is responsible for providing the clinical laboratory equipment and the researcher with the medical equipment for testing, and determining the transportation conditions, storage conditions, storage time, expiration date, etc.;
(5) The medical equipment for testing shall be of acceptable quality, with a special identification that is easy to identify, correctly coded and labeled with “testing”, and shall be properly packaged and stored in accordance with the requirements of the clinical trial plan;
(6) The sponsor shall formulate standard operating procedures related to quality control of clinical trials, such as transportation, receiving, storage, distribution, treatment, and recycling of medical devices for testing, for clinical laboratory institutions and researchers to follow.
Article 45 The sponsor is responsible for the safety of the medical device for testing in clinical trials. When it is found that it may affect the safety of the subject or the trial may change the ethics committee's approval of the continuation of the trial, the sponsor should immediately notify all clinical trial institutions and investigators and deal with them accordingly.
Article 46 If the sponsor decides to suspend or terminate the clinical trial, it shall notify all clinical trial institutions of the medical device clinical trial management department within 5 days and explain the reasons in writing. The clinical trial management department of the clinical trial institution shall promptly notify the appropriate researchers and ethics committees. Suspension of clinical trials may not be resumed without the consent of the ethics committee. After the end of the clinical trial, the sponsor shall inform the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government in writing.
Article 47 The sponsor shall ensure that all researchers conducting clinical trials strictly follow the clinical trial plan and find that clinical trial institutions and researchers fail to comply with relevant laws and regulations, this Code and clinical trial protocols, and shall promptly indicate and correct them; If the situation is serious or persists, the test shall be terminated and reported to the food and drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the clinical trial institution is located, and the State Food and Drug Administration.
Article 48 The sponsor shall bear the cost of treatment and the corresponding economic compensation for the subject who has suffered injury or death related to the clinical trial, except for the damage caused by the fault of the medical institution and its medical staff during the medical treatment.
Article 49 The sponsor shall undertake the audit responsibility for the clinical trial and select the auditors who meet the requirements to perform the audit duties.
The number of monitors and the number of audits depends on the complexity of the clinical trial and the number of clinical trials participating in the trial.
Article 50 The auditors shall have relevant professional backgrounds in clinical medicine, pharmacy, biomedical engineering, statistics, etc., and after necessary training, be familiar with relevant laws and regulations, and be familiar with the non-clinical and clinical aspects of the test medical devices. Clinical information, clinical trial protocols and related documentation for similar products.
Article 51 The auditor shall follow the operating procedures for clinical trials for clinical use of test medical devices formulated by the sponsor, and urge clinical trials to be carried out in accordance with the plan. Specific responsibilities include:
(1) Confirm that the clinical trial institution has appropriate conditions before the trial, including staffing and training meet the requirements, the laboratory is fully equipped and working well, and a sufficient number of subjects are expected to participate in the researcher's familiarity with the test requirements.
(2) Monitor clinical trial institutions and researchers before, during, and after the trial to comply with relevant regulations, this Code, and clinical trial protocols.
(3) Confirm that each subject signs an informed consent form before participating in the clinical trial to understand the subject's enrollment and the progress of the trial; follow-up, untested, and unfinished work that the investigator failed to do. The examination, as well as whether to correct the errors, omissions, etc., should be clearly and truthfully recorded; the revised informed consent confirms that the clinical trial process has not ended and the affected subjects are re-signed.
(4) Confirm that all case report forms are correctly filled out and consistent with the original materials; all errors or omissions have been corrected or indicated, signed and dated by the investigator; the number of diseases, the total number of cases and the gender of each case , age, treatment effect, etc. should be confirmed and recorded.
(5) Confirm that the subject withdraws from the clinical trial or does not comply with the requirements specified in the informed consent form, and discusses the situation with the investigator.
(vi) Confirmation of all adverse events, complications and other device defects are documented, serious adverse events and device defects that may lead to serious adverse events are reported and recorded within the specified time.
(7) Supply, use, maintenance, and transportation, receiving, storage, distribution, processing and recycling of medical device samples for testing.
(8) Supervising the regular maintenance and calibration of related equipment during the clinical trial.
(9) Ensure that all clinical trial-related documents received by the researcher are the latest version.
(10) The applicant shall report in writing after each audit. The report shall include the name of the auditor, the date of the audit, the time of the audit, the place of the audit, the content of the audit, the name of the researcher, the completion of the project, the existing problems, Conclusions and corrections to errors and omissions.
Article 52 In order to ensure the quality of clinical trials, the sponsor may organize a verifier who is independent of clinical trials and has appropriate training and experience to verify the clinical trials and evaluate whether the clinical trials meet the requirements of the trial protocol.
Verification can be used as part of the sponsor's routine work on quality management of clinical trials, as well as to assess the effectiveness of audit activities, or to verify for serious or repeated clinical trial program deviations, suspected fraud, etc.
Article 53 The verifier shall formulate verification plans and verification procedures based on the importance of clinical trials, the number of subjects, the type and complexity of clinical trials, and the risk level of subjects.
Article 54 For serious adverse events and equipment defects that may cause serious adverse events, the sponsor shall report to the food and drug supervision and administration department and the competent health and family planning department at the same time within 5 working days after being informed, and shall report to Other clinical trial institutions and researchers participating in the trial report and notify the ethics committee of the clinical trial institution through its medical device clinical trial management department.
Article 55 If the sponsor adopts an electronic clinical database or a remote electronic clinical data system, it shall ensure that the clinical data is controlled and true, and a complete verification document is formed.
Article 56 For multi-center clinical trials, the sponsor shall ensure that documents have been developed prior to the clinical trial to clearly coordinate the division of responsibilities between the investigator and other investigators.
Article 57 For multi-center clinical trials, the sponsor shall organize the development of standard operating procedures in accordance with the clinical trial protocol, and organize all the investigators involved in the trial to conduct clinical trial protocols and training for the use and maintenance of medical devices for testing, to ensure that Consistency in the use of clinical trial protocols and the use of medical devices for testing.
Article 58 In a multi-center clinical trial, the sponsor shall ensure that the design of the case report form is rigorous and reasonable, and that the coordinating researcher can obtain all the data of the clinical trial institutions of each sub-center.

Chapter VII Clinical Trial Institutions and Investigator Responsibilities

Article 59 Before accepting a clinical trial, a clinical trial institution shall evaluate the relevant resources according to the characteristics of the medical device for testing to determine whether to accept the clinical trial.
Article 60 The clinical trial institution shall properly keep the clinical trial records and basic documents in accordance with the agreement with the sponsor.
Article 61 The researcher responsible for clinical trials shall meet the following conditions:
(1) having the deputy chief physician, associate professor, associate researcher and other relevant senior professional titles and qualifications in the clinical trial institution;
(2) Having the professional knowledge and experience required for medical devices for testing, and training should be carried out when necessary;
(3) Familiar with the applicant's requirements and the information and literature related to the clinical trials provided by the sponsor;
(4) The ability to coordinate, control and use the personnel and equipment performing the test, and the ability to handle adverse events and other related events occurring in the test medical device;
(5) Familiar with relevant national laws, regulations and this Code.
Article 62 Before the clinical trial, the medical device clinical trial management department of the clinical trial institution shall cooperate with the sponsor to submit an application to the ethics committee and submit relevant documents in accordance with the regulations.
Article 63 The researcher shall ensure that the relevant staff involved in the test are familiar with the principle, scope of application, product performance, operation method, installation requirements and technical indicators of the medical device for testing, and understand the preclinical research materials of the medical device for testing and Safety information, to grasp the risk prevention and emergency treatment methods of clinical trials.
Article 64 The investigator shall ensure that all clinical trial participants fully understand the clinical trial protocol, relevant regulations, characteristics of the medical device for testing, and responsibilities related to clinical trials, and ensure that there are sufficient numbers and meet the criteria for inclusion in the clinical trial protocol. The tester enters the clinical trial to ensure that there is sufficient time to safely implement and complete the clinical trial in accordance with relevant regulations during the trial period agreed upon in the agreement.
Article 65 The investigator shall ensure that the medical device for testing is used only for the subjects of the clinical trial and shall not charge any fees.
Article 66 Researchers shall strictly follow the clinical trial plan and may not deviate from the program or substantively change the program without the consent of the sponsor and the ethics committee, or without the approval of the State Food and Drug Administration. However, in the case of an emergency in which the subject is faced with immediate danger and needs to be eliminated immediately, it can also be reported in writing afterwards.
Article 67 The investigator is responsible for recruiting the subject, talking to the subject or his guardian. It is the responsibility of the investigator to explain to the subject the details of the test medical device and clinical trials, to inform the subject of possible benefits and known, foreseeable risks, and to obtain signatures and notes from the subject or his or her guardian. Informed consent form for the date.
Article 68 The investigator or other personnel involved in the trial shall not force or otherwise induce the subject to participate in the trial.
Article 69 When a researcher finds an adverse event other than the expected medical device for clinical use in a clinical trial, he or she shall jointly modify the relevant content of the informed consent form with the sponsor, and report it to the ethics committee for approval according to the relevant working procedures. The affected subject or his or her guardian will re-sign the revised informed consent form.
Article 70 The investigator is responsible for making medical decisions related to clinical trials. In the event of adverse events associated with clinical trials, clinical trial institutions and investigators should ensure adequate and timely treatment and management of the subjects. When a subject develops a concurrent disease requiring treatment and management, the investigator should promptly inform the subject.
Article 71 If a serious adverse event occurs in a clinical trial, the investigator shall immediately take appropriate treatment measures for the subject, and report in writing to the medical device clinical trial management department of the clinical trial institution to which it belongs, and notify the application by written notice. By. The medical device clinical trial management department shall report in writing to the corresponding ethics committee and the food and drug supervision and administration department and the health and family planning department of the province, autonomous region, and municipality directly under the Central Government where the clinical trial institution is located within 24 hours. For death events, clinical trial institutions and investigators should provide the ethics committee and sponsor with all the information they need.
Article 72 The investigator shall record all adverse events and device defects found during the clinical trial, and jointly analyze the cause of the incident with the sponsor, form a written analysis report, and submit opinions on continuing, suspending or terminating the trial. The medical institution clinical trial management department of the testing institution reported to the ethics committee for review.
Article 73 The investigator shall ensure that the clinical trial data is accurately, completely, clearly and promptly included in the case report form. The case report form is signed by the investigator. Any changes to the data should be signed and dated by the investigator, while retaining the original record. The original record should be clearly identifiable.
Article 74 Clinical testing institutions and researchers shall ensure that the data, documents and records formed by clinical trials are true, accurate, clear and safe.
Article 75 Clinical trial institutions and researchers shall accept the sponsor's supervision, verification, and supervision by the ethics committee, and provide all the records required for the trial. Where the food and drug supervision and administration department and the health and family planning department send inspectors to carry out inspections, the clinical trial institutions and researchers shall cooperate.
Article 76: Clinical trial institutions and researchers may find that the risk exceeds the possible benefits, or have obtained sufficient results to judge the safety and effectiveness of the medical device for testing, etc., and the patient should be notified when the clinical trial needs to be suspended or terminated. Subjects are guaranteed appropriate treatment and follow-up, as well as a detailed written explanation in accordance with the regulations. Report the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government when necessary.
When the researcher receives a notification that the sponsor or ethics committee needs to suspend or terminate the clinical trial, the investigator should promptly notify the subject and ensure that the subject receives appropriate treatment and follow-up.
Article 77 If a clinical trial institution or researcher violates relevant regulations or requests to change test data and conclusions, the applicant shall report to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the sponsor is located or the State Food and Drug Administration.
Article 78 At the end of a clinical trial, the investigator shall ensure that all records and reports are completed. At the same time, the investigator should also ensure that the medical equipment received for testing meets the quantity used, discarded or returned, ensuring that the remaining medical equipment for testing is properly handled and documented.
Article 79 The researcher may authorize the corresponding personnel to conduct recruitment of the subject, continuous communication with the subject, clinical trial data recording, and medical device management for testing according to the needs of the clinical trial. Researchers should conduct relevant training and form appropriate documentation for their authorized personnel.


Chapter VIII Records and Reports

Article 80 In clinical trials, the investigator shall ensure that any observations and findings are recorded correctly and completely, and that the case report form is carefully completed. Records should at least include:
(1) Information on the medical device used for the test, including name, model, specification, date of receipt, batch number or serial number;
(2) Medical records, nursing records, etc. related to the medical history and progress of each subject;
(3) The record of each patient using the medical device for testing, including the date and time of each use, the state of the medical device for testing, etc.;
(4) The signature and date of the recorder.
Article 81 The clinical test records shall not be arbitrarily changed as the original materials; the reasons, signatures and dates shall be stated when changes are required.
Data that deviates significantly from the clinical trial protocol or outside the clinically acceptable range should be verified and the investigator makes the necessary instructions.
Article 82 The sponsor shall accurately and completely record the information related to the clinical trial, including:
(1) The medical device transport and processing records for the test, including the name, model, specification, batch number or serial number, the recipient's name, address, date of delivery, return of repair or clinical test sample recovery and disposal date, cause and Processing method, etc.;
(2) an agreement with a clinical trial institution;
(3) Audit report and verification report;
(4) Recording and reporting of serious adverse events and device defects that may lead to serious adverse events.
Article 83 The researcher shall verify or confirm the safety and effectiveness of the medical device for testing according to the design requirements of the clinical trial plan, and complete the clinical trial report. Clinical trial reports for multicenter clinical trials should include a summary of clinical trials at each subcenter.
Article 84 For multi-center clinical trials, the clinical trial summary of each sub-center should include at least the clinical trial profile, clinical general information, test medical device and control medical device information description, safety and validity data set, and poor The incidence rate of the incident, as well as the treatment situation, the description of the deviation of the program, etc., together with a case report form.
Article 85 The clinical trial report shall be consistent with the clinical trial plan, which mainly includes:
(1) General information;
(2) Summary;
(3) Introduction;
(4) The purpose of clinical trials;
(5) Clinical test methods;
(6) Clinical trial content;
(7) Clinical general information;
(8) Medical devices for testing and medical devices for comparison or control methods;
(9) Statistical analysis methods and evaluation methods used;
(10) Clinical evaluation criteria;
(11) The organizational structure of clinical trials;
(12) Description of ethical situation;
(13) Clinical trial results;
(14) Adverse events found in clinical trials and their treatment;
(15) Analysis and discussion of clinical trial results, especially indications, scope of application, contraindications and precautions;
(16) conclusions of clinical trials;
(17) Problems and suggestions for improvement;
(18) A list of testers;
(19) Other circumstances that need to be explained.
Article 86 The clinical trial report shall be signed and dated by the investigator, and submitted to the sponsor after the clinical trial institution's medical device clinical trial management department has issued an opinion, dated and stamped the seal of the clinical trial institution.
In multi-center clinical trials, the clinical trial summary of each sub-center should be signed and dated by the researcher of the center, and reviewed by the medical device clinical trial management department of the center, dated and stamped with the seal of the clinical trial institution. unit.


Chapter IX Medical Device Management for Testing

Article 87 The sponsor shall, in accordance with the provisions of the State Food and Drug Administration of the medical device manual and label management, properly label the medical device for testing and mark it as “testing”.
Article 88 The records of medical devices for testing include production-related records such as production date, product batch number, serial number, etc., inspection records related to product quality and stability, and records used for transportation, maintenance, and delivery of clinical trial institutions. And information on the date of recovery and disposal after the test.
Article 89 The use of medical devices for testing shall be the responsibility of the clinical testing institution and the investigator. The investigator shall ensure that all medical devices for testing are used only for the subjects of the clinical trial, and the test is stored and stored as required during the test. Medical devices, after clinical trials, in accordance with the relevant national regulations and the agreement with the sponsor to treat the medical devices for testing. The above process needs to be handled and recorded by a special person. Researchers may not transfer test medical devices to any non-clinical trial participants.


Chapter 10 Basic Document Management

Article 90 Clinical laboratory institutions, researchers and sponsors shall establish a basic document preservation system. The basic documents of the clinical trial are divided into three parts according to the clinical trial stage: the preparation stage document, the stage stage document and the termination or completion of the file.
Article 91 The clinical trial institution shall keep clinical trial data until 10 years after the end of the clinical trial. The sponsor should save the clinical trial data until the medical device is used.
Article 92 The basic documents of clinical trials can be used to evaluate the implementation of the Code and the relevant requirements of the food and drug supervision and administration department by the sponsor, clinical trial institutions and researchers. The food and drug supervision and administration department can check the basic documents of clinical trials.


Chapter XI Supplementary Provisions

Article 93 The meaning of the following terms in this Code:
The medical device clinical testing institution refers to the medical institution that undertakes the medical device clinical trial as determined by the State Food and Drug Administration and the National Health and Family Planning Commission. Unless otherwise stated, the “clinical testing institution” in this specification refers to the “medical device clinical testing institution”.
A medical device for testing refers to a medical device to be registered for verification or verification of its safety and effectiveness in clinical trials.
The sponsor refers to the institution or organization that initiates, manages, and provides financial support for clinical trials.
Researcher refers to the person responsible for implementing clinical trials in a clinical trial institution. If a trial is performed by a group of people in a clinical trial facility, the investigator refers to the person in charge of the group, also known as the primary investigator.
An ethics committee is an independent body set up by a clinical trial organization to review the scientific and ethical nature of clinical trials of medical devices.
The medical device clinical trial management department refers to the department or department set up in the clinical trial institution responsible for the organization management and quality control of the medical device clinical trial.
Multi-center clinical trials refer to clinical trials conducted in more than three (including three) clinical trial institutions in accordance with the same clinical trial protocol.
A subject is an individual who is recruited for a clinical trial of a medical device.
Informed consent is the process by which the subject confirms the voluntary participation in the clinical trial after the subject has been informed of all aspects of the clinical trial. The signed and dated informed consent form should be used as supporting documentation.
Informed consent is a documentary evidence that the subject indicated that he or she volunteered to participate in a clinical trial.
The inspection refers to the sponsor to ensure that the clinical trials can follow the clinical trial protocol, standard operating procedures, this specification and relevant applicable management requirements, and select special personnel to conduct evaluation and investigation on clinical trial institutions and researchers. The data in the validation and recording and reporting activities.
The auditor refers to the special personnel selected by the sponsor to monitor the medical device clinical trial project.
Verification refers to a systematic and independent examination of clinical trial-related activities and documents organized by the sponsor to determine whether the execution of such activities, data recording, analysis and reporting conform to clinical trial protocols, standard operating procedures, and this specification. And regarding applicable regulatory requirements.
A verifier is a person who is commissioned by the sponsor to verify the medical device clinical trial project.
Inspection refers to the supervision and management activities of the regulatory authorities on relevant documents, facilities, records and other aspects of clinical trials.
An inspector is a person selected by the regulatory authority to inspect a medical device clinical trial project.
Deviation refers to situations where the clinical trial protocol requirements are not followed intentionally or unintentionally.
The case report form refers to a document designed in accordance with the clinical trial protocol to record all the information and data of each subject obtained during the trial.
End point is the indicator used to assess clinical trial hypotheses.
Source data, which refers to the original records of clinical findings, observations, and other activities in clinical trials, as well as all information in their approved copies, can be used for clinical trial reconstruction and evaluation.
A source file is a printed file, a visual file, or an electronic file that contains source data.
Adverse events refer to adverse medical events that occur during clinical trials, whether or not related to the medical device being tested.
Severe adverse events refer to deaths or serious deterioration of health conditions during clinical trials, including fatal diseases or injuries, permanent defects in body structure or bodily functions, hospitalization or lengthening of hospital stay, medical or surgery required Intervention to avoid permanent defects in body structure or body function; cause fetal distress, fetal death or congenital anomalies, congenital defects and other events.
Device defects refer to unreasonable risks that may endanger human health and life safety during medical use during clinical trials, such as label errors, quality problems, and malfunctions.
Standard operating procedures refer to the standards and detailed written procedures developed for the effective implementation and completion of each of the clinical trials.
Clinical data refers to the safety and performance information obtained in the clinical use of relevant literature or medical devices.
Article 94 The format template of the medical device clinical trial ethics review application approval form and other documents shall be separately formulated by the State Food and Drug Administration.
Article 95 This Code does not apply to in vitro diagnostic reagents managed in accordance with medical devices.
Article 96 This Code shall come into force on June 1, 2016. The Medical Device Clinical Trial Regulations issued by the State Food and Drug Administration (No. 5 of the State Food and Drug Administration) issued on January 17, 2004 shall be abolished at the same time.

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