Chapter 1 General Principles

Article 1 In order to strengthen the management of clinical trials of medical device，Maintenance of the subject's rights and interests during the clinical trial of medical device，Make sure the clinical trial process specifications of medical equipment，The result is true、Science、Reliable and traceable，According to the "Regulations on the Supervision and Administration of Medical Device"，Develop this specification。

The second clinical trial of medical device in the People's Republic of China，It should follow this specification。
This specification covers the entire process of clinical trials of medical equipment，Plan design including clinical trials、Check、Monitoring、Check、Check，and data collection、Record，Analysis and summary and report。

Article 3 The clinical trial of medical device referred to in this specification，refers to the clinical trial institution of medical device in the qualifications，The process of confirming or verifying the safety and effectiveness of the medical device that plans to be registered under normal use。

Article 4 The clinical trial of medical device shall follow the principle of law、Ethics principles and scientific principles。

Article 5 The food and drug supervision and management department at or above the provincial level is responsible for the supervision and management of clinical trials of medical equipment。
The competent department of health and family planning to strengthen the management of clinical trials of medical equipment within the scope of duties。
Food and Drug Supervision and Management Department、The competent department of health and family planning shall establish a reporting mechanism for the quality management information management information of clinical trials of medical device，Strengthen the third type of medical equipment、In included in the national large -scale medical equipment configuration management products, medical devices for clinical trial approval and corresponding clinical trial supervision and management data were notified。

Chapter 2 Preparation of Clinical Test

1 6 of the clinical trials of medical device should have sufficient scientific basis and clear test purpose，And weighing the benefits and risks of the health expectations of the subject and the public，The expected benefit should exceed possible damage。

1 clinical trial，The applicant shall complete the pre -clinical study of test medical equipment，Including product design (structure composition、Working principle and mechanism of action、The expected use and scope of application、Applicable technical requirements) and quality inspection、Animal Test and Risk Analysis, etc.，As a result, it should be able to support this clinical trial。Quality inspection results include self -inspection reports and qualified inspection agencies issued within one year of product registered inspection qualification report。

1 clinical trial，The applicant should prepare sufficient test medical equipment。The development of test medical devices for test should meet the relevant requirements of the applicable medical device quality management system。

Article 9 of the clinical trial of medical device shall be performed in two or more medical device clinical trial institutions。
The selected test institutions should be the clinical trial institution of medical device for medical device for qualifications，and facilities and conditions should meet the needs of safe and effective clinical trials。Researchers shall have a professional expert that undertakes this clinical trial、Qualification and ability，and after training。
The qualifications of medical device clinical trial institutions are formulated by the State Food and Drug Administration in conjunction with the State Health and Family Planning Commission。

Article 10 Before the clinical trial，Applicants and clinical trial institutions and researchers should be designed for the test、Test quality control、Division of responsibilities in the test、The clinical trial related costs undertaken by the applicant reached a written agreement。

Article 11 Clinical trials shall obtain the consent of the ethical committee of the medical device clinical trial institution。The third category of medical device catalogs that need to be approved for clinical trial approval，It should also be approved by the State Food and Drug Administration。

Article 12 Clinical trial，The applicant shall be provinced to the local area、Autonomous Region、Food and Drug Supervision and Administration of Food and Drug Administration directly under the Central Government。
The filing of the filing of the food and drug supervision and management department shall notify the filing situation of the same level of food and drug supervision and management department of the clinical trial institution and the competent health family planning department。

Chapter III Against Rights Protection

Article 13 The clinical trials of medical device shall follow the ethical guidelines determined by the World Medical Conference Herxia Declaration。

Article 14 Ethics review and informed consent is the main measure to protect the rights and interests of the subjects。
All parties participating in clinical trials shall assume corresponding ethical responsibilities in accordance with their respective responsibilities。

Article 15 Specialists shall avoid the subject、Clinical trial institutions and researchers and other clinical trial participants or related parties have improper effects or misleading。
Clinical trial institutions and researchers should avoid the subject、Applicants and other clinical trial participants or related parties have improper effects or misleading。

Article 16 Specialist、Clinical trial institutions and researchers must not exaggerate compensation measures to participate in clinical trials，Misacked the subject participating in clinical trials。

Article 17 Pre -clinical trial，The applicant shall submit the following documents to the Ethics Commission through researchers and clinical trial institutions' medical device clinical trial management departments:
(1) Clinical trial plan;
(2) Researcher manual;
(3) The text of informed consent and any other written materials provided to the subject;
(4) Recruiting subjects and procedural files promoted to them;
(V) Report text of the case;
(6) Self -inspection report and product registration inspection report;
(7) Researcher resume、Professional expertise、Ability、Receive training and other documents that can prove their qualifications;
​​(8) The facilities and conditions of clinical trial institutions can meet the review of the test;
(9) Development of test medical devices for testing meets the relevant requirements of the applicable medical device quality management system;
(10) Other documents related to ethical review.
The Ethics Committee shall adhere to the principles of ethics and science，Examination and supervision of the implementation of clinical trials。

Article 18 of the following situations during the clinical trial，Researchers shall report to the clinical trial management department of the clinical trial institution in a timely manner，and inform the applicant in a timely manner、Report Ethics Committee:
(1) Severely adverse events;
(2) Progress report，Including safety summary and departure report;
(3) Any revision of the Ethical Committee approved documents，It does not affect the subject's rights and interests、Safety and Health，Or intangible changes that are not related to clinical trial purposes or endpoints do not need to report beforehand，But in writing afterwards;
(4) Passing、Request clinical trials after termination or suspension;
(5) Affects the subject's rights and interests、Safe and healthy or clinical trial scientific clinical trial scheme deviations，Including request deviation and report deviation。
To protect the subject's rights and interests、Safety and Health，The deviation that occurs in the emergency cannot be reported in time，It should be reported as soon as possible in writing in writing in writing afterwards。

Article 19 During the clinical trials，such as revising clinical trial plans and informed consent forms、Request deviation、Restore has suspended clinical trials，It shall continue to be implemented after obtaining the written approval of the Ethics Committee。

Article 20 shall avoid choosing minors、Pregnant Women、Elderly、Intellectual obstacles、Patients in the crisis of life as a subject;，It should abide by the relevant additional requirements proposed by the Ethics Committee，Special design for its health in clinical trials，and it should be beneficial to its health。

21: Before the subject participated in clinical trials，Researchers should fully fulfill the subject of the subject or the ability of no civil behavior、The guardian of the person who restricts the ability of civil behavior explains the detailed situation of clinical trials，Including known、Prediction of risks and possible adverse events。After full and detailed interpretation, the subjects or their guardians signed the name and date on the informed consent form，Researchers also need to sign the name and date on the informed consent form。

Article 22 The consent of informed consent should generally include the following content and explanation of matters:
(1) The name and related information of the researcher;
(2) The name of the clinical trial institution;
(3) Test name, purpose, method, method, content;
(4) The test process and time limit;
(5) The source of funds of the test、Possible conflicts of interest;
(6) It is expected to benefit and known the possible beneficiaries of the subject、predictable risks and possible adverse events;
(7) The alternative diagnosis and treatment method that the subject can obtain and the potential benefit and risk information;
(8) When needed,，Explain that the subject may be assigned to different groups of the test;
(9) The subject participating in the test should be voluntary，and at any stage of the test, have the right to exit without being discriminated against or revenge，Its medical treatment and equity are not affected;
(10) Inform the subject's personal Stake Sports Bettinginformation stake sports betting appthat the subject participating in the test is confidential，But the Ethics Committee、Food and Drug Supervision and Management Department、The competent department of health and family planning or applicants can check the personal information of the subject to participate in the test in accordance with the prescribed procedures at the time of work;
(11) If the damage related to the test occurs，The subject can get treatment and economic compensation;
(Twelve) The subject can know the information related to it at any time during the test;
(13) Free diagnosis and treatment items and other related subsidies that the subject may get during the test。
The consent of informed consent shall use the language and text that the subject or the guardian can understand。The consent of the informed consent should not contain the subject of the subject to abandon the legitimate rights and interests and exempt the clinical trial institutions and researchers、The content of the applicant or its agent should be responsible。

Article 23 to obtain informed consent shall also meet the following requirements:
(1) A subject with no behavior，If the Ethics Committee agrees in principle、Researchers believe that when the subject participating in clinical trials meets its own interests，You can also enter clinical trials，But the date should be signed and indicated by the guardian before the test;
(2) When the subjects or their guardianship have no reading ability，In the process of informedness, a witness should be present，After detailed explanation of informed consent,，Witnesses Reading Integrity Commendation and Oral Knowing Contents，After the subject or its guardian agrees with verbally，The witness signed and indicated the date on the informed consent form，The signature of the witness should be on the same day as the researcher's signature;
(3) Minor as a subject，The informed consent of the guardian should be obtained and signed the informed consent，minors can make an intention to participate in the test，It should also obtain its own consent;
(4) If you find important information involved in test medical devices or clinical effects other than expected，The relevant content of the informed consent form should be modified，A modified informed consent was approved by the Ethics Committee，It should be re -signed by the subject or its guardian。

Article 24 The consent of the informed consent shall indicate the date of the formulation or the date of the revised version。If the consent of Knowledge is amended during the test，A revised version of the informed consent must be re -approved by the Ethics Committee again。A revised version of the informed consent of the newspaper newspaper clinical trial institution，All subjects who have not ended the test process are affected，All should sign a new revised informed consent。

Article 25 The subject has the right to withdraw at any stage of clinical trials and does not bear any economic responsibility。

Chapter 4 Clinical Test Plan

Article 26 Carry out clinical trials of medical equipment，The applicant shall follow the category of the test medical equipment、Risk、It is expected to formulate science、Reasonable clinical trial scheme。

Article 27 New products that have not been approved at home and abroad，Safety and performance have not yet been confirmed by medicine，The clinical trial solution should be conducted first in small sample feasibility tests，After preliminary confirmation of its safety，Then determine the sample volume to carry out follow -up clinical trials in accordance with statistical requirements。

Article 28 of the clinical trial plan of medical device shall include the following content:
(1) General information;
(2) Background information of clinical trials;
(3) Test purposes;
(4) Test design;
(5) Safety evaluation method;
(6) Effective evaluation method;
(7) Statistical considerations;
(8) Amendments to the clinical trial plan;
(9) Regulations on adverse events and equipment defect reports;
(Ten) Visits the source data and files directly;
(11) The ethical issues and descriptions involved in clinical trials, as well as the text of informed consent;
(12) Data processing and record preservation;
(13) Finance and insurance;
(14) The test results were issued.
The above content can be included in other related documents of the plan, such as in the researcher's manual。The specific information of the clinical trial agency、Test results publish an agreement、Finance and insurance can be expressed in the test plan，You can also formulate a separate agreement to specify。

29 The clinical trials of multiple centers by multiple researchers will be performed in different clinical trial institutions in different clinical trials in accordance with the same experimental scheme。The design and implementation of its experimental scheme shall include at least the following content:
(1) The test plan is formulated by the organizer and discussed and determined by various clinical trial institutions and researchers，Researched researchers at the clinical trial institution of the lead unit are coordinated researchers;
(2) Coordinating researchers are responsible for work coordination between clinical trial institutions during clinical trials，Pre -clinical trials、Mid -term and later Organization Researcher Meeting，and jointly the implementation of the entire test with the applicant;
(3) Each clinical trial institution should carry out and end clinical trials in principle;
(4) Test samples and allocation of clinical trial institutions、Reasons to meet the requirements of statistical analysis;
(5) Specialist and clinical trial agencies' planning and training records on test training;
(6) Establish test data transmission、Management、Check and query program，In particular, it is clearly required that the data of the test data of each clinical trial institution shall be centrally managed and analyzed by the lead unit;
(7) After the clinical trial of multi -center，Researchers of various clinical trial institutions shall issue summary clinical trials respectively，Together with the medical record report form, it is submitted to the coordinated researcher to complete the summary report after reviewing the review。

Chapter 5 Ethics Committee Responsibilities

Article 30: The Ethics Committee of the Clinical Test Institution of Medical Devices shall consist of at least 5 members，Including medical professionals、Non -medical professionals，Among them, there should be members of different gender。At least one of the non -medical professional committee members are called legal workers，A person who is outside the clinical trial institution。Member of the Ethics Committee shall have science for evaluation and evaluation of this clinical trial、Qualification or experience in medicine and ethics。All members should be familiar with the ethical criteria and relevant regulations of the clinical trials of medical device，Follow the charter of the Ethical Committee。

Article 31 of the Medical Devices Ethics Committee shall comply with the Ethical Standards for the World Medical Conference Herxia Declaration and the provisions of the food and drug supervision and management department，Create the corresponding working program and form a file，Performing the responsibilities according to the working process。
The members of the researchers and applicants in the Ethics Committee have the right to express their opinions and participate in the experimental voting。

Article 32 The Ethics Committee holds a meeting shall notify in advance，The number of participants and voting must not be less than 5，Any decision to make a decision should be passed by more than half of the members of the Ethics Commission.。
Researchers can provide information about any aspect of the test，But not to participate in the review、Vote or express opinions。
The Ethics Committee is reviewing some special tests，Experts in related fields can be invited to participate。

Article 33 The Ethics Commission shall strictly review the test plan and related documents from the perspective of protecting the rights and interests of the subjects，and should focus on the following content:
(1) Eligibility of researchers、Experience and whether you have enough time to participate in the clinical trial。
(2) Whether the personnel equipment and equipment conditions of the clinical trial institution meet the test requirements。
(3) Whether the degree of risk that the subject may suffer is appropriate compared to the expected benefit of the test。
(4) Whether the test plan fully considers ethical principles，Whether it is in line with science，Including whether the research purpose is appropriate、Whether the subject's rights are guaranteed、Other people may suffer risk protection and whether the subject selected is scientific。
(5) The subject selected method，Whether the information and materials provided by the subject or the guardian are complete、Whether the subject can understand，Whether the method of obtaining the consent of knowledge is appropriate; if necessary，The Ethical Committee shall organize the test of the test of the test.，Evaluate whether the consent of informedness is appropriate，Assessment results should be recorded in writing and stored until the end of the clinical trials for 10 years。
(6) If the subjects have harm or death related to clinical trials，Is the treatment and insurance measures given enough。
(7) Whether the modification opinions on the test plan are acceptable。
(8) Whether a regular analysis and evaluation can be performed in clinical trials to possible harm to the subject。
(9) The deviation of the test plan may affect the subject's rights and interests、Safety and Health，or the scientific nature of the test、Integration，Is it acceptable。

Article 34 The ethical review of clinical trials of multiple centers shall shall be responsible for establishing a collaborative review work procedure by the Ethics Committee of the Leading Unit，Make sure the consistency and timelyness of the review work。
The trials of each clinical trial institution shall be responsible for the ethical and scientificity of the ethical and scientificity of the Ethical Committee of the Leading Unit to review the test plan，Other clinical trial institutions participating in the experiment on the ethics committee of the ethics committee of the ethics committee of the lead unit，You can use the method of conference review or file censors，Test the feasibility of the test in this clinical trial agency，Including the qualifications and experience of researchers、Equipment and conditions, etc.，Under normal circumstances, no longer put forward a modification opinion on the design of the test plan，But there is the right to test the test at its clinical trial institution。

Article 35 The Ethical Committee shall hold a meeting after receiving a clinical trial receiving a medical device clinical trial，Review Discussion，Send written opinion、Casting，List of personnel attending the meeting、Professional and stake betting appmy signature。The opinions of the Ethical Committee can be:
(1) Agree;
(2) Agree with the necessary modification;
(3) Disagree;
(4) Pass or terminate the approved test.

Article 36 The Ethics Commission shall track the clinical trials of this clinical trial agency，It is found that the subject's rights and interests cannot be guaranteed，You can suspend or terminate the clinical trial at any time at any time。
The suspend clinical trial，Without the consent of the Ethics Committee，Do not recover。

Article 37 The Ethical Committee shall retain all the relevant records until the clinical trial is completed for at least 10 years。

Chapter 6 Specialist Responsibilities

Article 38: Specializers are responsible for initiating、Application、Organization、Monitor clinical trial，The authenticity of clinical trials、Responsibility for reliability。Subsiders are usually medical device manufacturers。The applicant is an overseas institution，The agent should be specified in my country。

Article 39 Substitutors are responsible for organizing formulation and modifying researchers' manuals、Clinical trial plan、Knowing Consent for Infliance、Case Report Form、Relevant standard operating procedures and other related documents,Responsible for organizing training necessary for clinical trials。

Article 40 The applicant shall be based on the characteristics of the test medical equipment，Select the test agency and its researcher in the qualified medical device clinical trial agency。Applicants before signing a clinical trial agreement with clinical trial institutions，It should provide the latest researchers and other related documents to clinical trial institutions and researchers，To decide whether it can bear this clinical trial。

Article 41 Researchers shall include the following main content:
(1) Basic information of applicants and researchers;
(2) Summary description of the test of medical devices;
(3) Support and evaluation of the expected use and clinical trial design of medical equipment for testing;
(4) The manufacturing of testing medical devices in the test meets the requirements of the applicable medical equipment quality management system。

Article 42 The organizers shall not exaggerate the mechanism and efficacy of publicity and test medical devices in the formulation of clinical trials。

Article 43 In the clinical trial process，When the applicant gets important information that affects clinical trials，It should be modified in a timely manual manual and related documents in time，and through the clinical trial management department of the clinical trial institution of the clinical trial institution submitted to the Ethical Committee for review and consent。

Article 44 The spover shall reach a written agreement with the clinical trial institution and researchers:
(1) Clinical trials in accordance with relevant laws and regulations and clinical trial plans，and undergoing monitoring、Check and check;
(2) Follow the data records and reporting procedures;
(3) Reserved basic documents related to testing are not less than legal time，Until the applicant notifys the clinical trial institutions and researchers no longer need this file;
(4) After the applicant was approved by the Ethics Committee，Responsible for providing experimental medical equipment to clinical trial institutions and researchers，and determine its transportation conditions、Storage conditions、Storage time、Validity period, etc.;
(5) Experimental medical equipment shall be qualified for quality，Have easy recognition、Correct encoding and special logo with "test"，and properly packaged and stored in accordance with the requirements of the clinical trial plan;
(6) Subsiders shall formulate standard operating procedures related to the quality control of clinical trials，For the transportation of medical equipment for test、Receive、Storage、distribution、Treatment、Recycling, etc.，For clinical trial institutions and researchers follow。

Article 45 The sportiers are responsible for the safety of test medical devices in clinical trials。When it is found that it may affect the subject's safety or test implementation may change the approval of the ethics committee for continuing test，The applicant shall immediately notify all clinical trial institutions and researchers，Make corresponding treatment。

Article 46 The applicant decides to suspend or terminate clinical trials，Should notify all clinical trial institutions medical device clinical trial management department within 5 days，Two reasons for writing。The clinical trial institutional medical device clinical trial management department shall promptly notify the corresponding researcher、Ethics Committee。Clinical trials of suspended clinical trials，Without the consent of the Ethics Committee，Do not recover。After the clinical trial is over，The applicant shall inform the province where it is located、Autonomous Region、Food and Drug Supervision and Management Department of Municipality。

Article 47 Specialists shall ensure that all researchers who implement clinical trials strictly follow the clinical trial plan，Discovery clinical trial institutions and researchers do not follow relevant laws and regulations、This specification and clinical trial scheme，It should be pointed out and corrected in time; if the situation is serious or does not change，The test should be terminated，province to the location of the clinical trial institution、Autonomous Region、Report on the Food and Drug Supervision and Administration of Food and Drugs and State Food and Drugs。

Article 48 The applicant shall undertake the cost of treatment and the corresponding economic compensation for the harm or death of the patients related to clinical trials，But except the damage caused by the fault of medical institutions and their medical staff during diagnosis and treatment activities。

Article 49 Specialty shall bear the responsibility for the clinical trials，and select the monitor that meets the requirements to perform the monitoring responsibility。
The number of monitors and the number of monitoring depends on the complexity of clinical trials and the number of clinical trials participating in the test。

100 Inspectors shall have a corresponding clinical medicine、Pharmacy、Biomedical Engineering、Statistics and other related professional backgrounds，and after necessary training，Familiar with relevant regulations and this specification，Familiar with the non -clinical and clinical information of the test of medical devices for testing medical devices、Clinical trial scheme and related documents。

Article 51 Inspectors shall follow the operating procedures for clinical trial monitoring of medical devices formulated by the tip，Urgent clinical trials to be implemented in accordance with the plan。Specific responsibilities include:
(1) It is confirmed that the clinical trial agency has appropriate conditions before the test，Including personnel equipment and training meet the requirements，Laboratory equipment is complete、Good work situation，It is expected to have sufficient number of subjects，Participating in researchers familiar with the test requirements。
(2) Before the test、Middle、Whether the clinical trial institutions and researchers follow relevant regulations in the later monitoring of clinical trial institutions、This specification and clinical trial plan。
(3) Confirm that each subject signed an informed consent before participating in clinical trials，Understand the selection of the subject and the progress of the test;、Unporing tests、Not done inspection，or not right、omissions to make corrections，It should be clear、Records truthfully;，Awarded by the subject who has not ended the clinical trial process and affected by the affected signed。
(4) Confirm that all cases report forms are filled in correct，and consistent with the original information; all errors or omissions have been corrected or indicated，signed by the researcher and indicated the date;、The total number of cases and the gender of the case、Age、The treatment effect, etc., should be confirmed and recorded。
(5) Confirm that the subject withdraws from clinical trials or is recorded in the case，and discuss this situation with researchers。
(6) Confirm all bad events、The complications and other equipment defects are recorded in the case，Severe adverse events and device defects that may cause serious adverse events to make reports within the prescribed time and record in the case。
(7) Supply of medical device samples for inspection test、Use、Maintenance and transportation、Receive、Storage、distribution、Treatment and recycling。
(8) Regular maintenance and calibration of related equipment during the clinical trials。
(9) Make sure all the clinical trials related to the researcher received are the latest version。
(10) Each time it is monitored, the applicant shall be reported in writing，The report shall include the monitor's name、Inspection Date、Inspection time、Inspection location、Inspection content、Researcher's name、Project completion、Existing problems、Conclusion and right error、Correction made of omissions。

Article 52: The quality of the organizers to ensure the quality of clinical trials，You can organize independent clinical trials、Inspectors with corresponding training and experience to check the development of clinical trials，Evaluate whether the clinical trial meets the requirements of the test plan。
Check can be used as part of the common work of the quality management of the organizer，It can also be used to evaluate the effectiveness of monitoring activities，Or a serious or repeated clinical trial solution departs、Suspected fraud and other conditions to conduct verification。

Article 53 Inspectors shall be based on the importance of clinical trials、Number of subjects、Types and complexity of clinical trials、The subject's risk level is formulated to formulate a verification plan and verification procedure。

Article 54 For device defects for severe adverse events and may lead to serious adverse incidents，The applicant shall report to the food and drug supervision and management department and the competent health family planning department at the same level within 5 working days after learning，At the same time, it should be reported to other clinical trial institutions and researchers participating in the trial，and the clinical trial management department of its medical device inform the ethics committee of the clinical trial agency。

Article 55 If the applicant uses an electronic clinical database or remote electronic clinical data system，It should ensure the control of clinical data、True，and form a complete verification file。

Article 56 For multi -center clinical trials，The applicant shall guarantee that files have been formulated before clinical trials，Clarify the division of responsibilities of researchers and other researchers。

Article 57 For multi -center clinical trials，The applicant shall formulate standard operating procedures in accordance with the clinical trial plan，Organize the training of all researchers participating in the test and the training of the use and maintenance of medical equipment for testing，Make sure to perform the implementation of the clinical trial plan、The consistency of the use of test medical equipment。

Article 58 In multi -center clinical trials，The applicant stake betting appshall guarantee the design My stake betting appof the report form of the case rigorous and reasonable，Can enable coordinated researchers to obtain all data from clinical trial agencies of each branch。

Chapter 7 Clinical Test Institution and Researcher Responsibilities

Article 59 of the clinical trial institution before receiving clinical trials，The characteristics of medical devices should be based on the test，Evaluate related resources，To decide whether to receive the clinical trial。

Article 60 Clinical trial institutions shall properly preserve clinical trial records and basic documents in accordance with the agreement with the applicant。

Article 61 Researchers responsible for clinical trials shall have the following conditions:
(1) There is a deputy chief physician in this clinical trial institution、Associate Professor、Associate Researcher and other related professional technical titles and qualifications;
(2) Professional knowledge and experience required by testing medical devices，Relevant training shall be undernect if necessary;
(3) Familiar with the requirements of the applicant's requirements to the clinical trials it provided、Literature;
(4) Be able to coordinate、Personnel and equipment for this test，It is capable of dealing with bad events and other related events that occur in testing medical devices;
(5) Familiar with relevant national laws、Regulations and this specification。

Article 62 Pre -clinical trial，The medical device clinical trial management department of the clinical trial institution shall cooperate with the applicant to apply to the Ethics Commission，and submit relevant documents in accordance with regulations。

Article 63 Researchers shall ensure that the relevant staff participating in the test are familiar with the principle of testing medical equipment、Applicable range、Product performance、Operation method、Installation requirements and technical indicators，Know the pre -clinical research data and safety information of the test for the test for the test，Mastering the prevention of risk and emergency treatment method of clinical trials。

Article 64 Researchers shall ensure that all clinical trial participants fully understand the clinical trial plan、Related Regulations、Test medical equipment characteristics and responsibilities related to clinical trials，and ensure that a sufficient number and meet the clinical trial plan selected standards to enter the clinical trial、Make sure that there is enough time to be within the trial period agreed in the agreement，Practice and complete clinical trials safely in accordance with relevant regulations。

Article 65 Researchers shall guarantee that the test of the test medical device is only used for the subject of the clinical trial，You must not charge any fee。

Article 66 Researchers shall strictly follow the clinical trial plan，Without the consent of the applicant and the Ethics Committee，Or it is not approved by the State Food and Drug Administration in accordance with the regulations，Do not deviate from the plan or the substantial change plan。But in an emergency when the subjects are facing direct danger, etc.，You can also report in writing afterwards。

Article 67 Researchers are responsible for recruiting subjects、Talk to the subject or its guardian。Researchers have the responsibility to explain to the subjects to explain the detailed situation of test medical equipment and clinical trials，Inform the subject that the possible benefit and known、Predicable risks，and obtain the subject of the subject of the subject or the guardian's signature and indicating the date of informed consent。

Article 68 Researchers or other personnel participating in the test，Should not be forced or seduces the subjects to participate in the test。

Article 69 Researchers found in clinical trials that when there were bad events expected to test medical device in clinical trials，It should be modified with the relevant content of informed consent with the applicant，After reporting the Ethical Committee for review and consent in accordance with the relevant working procedures，Re -signed and confirmed the modified consent of informed consent from the affected subjects or the guardian。

Article 70 Researchers are responsible for making medical decisions related to clinical trials，When a bad event related to clinical trials occurs，Clinical trial institutions and researchers shall guarantee enough to provide the subject with sufficient、Timely treatment and treatment。When the subject needs to be treated and treated with a concurrent disease，Researchers should inform the subject in time。

Article 71 in clinical trials，Researchers shall immediately take appropriate treatment measures to the subjects，At the same time, the clinical trial management department of the clinical trial institution that belongs to the clinical trials of the clinical trial institution，and notify the applicant in writing。The clinical trial management department of the medical device shall report the corresponding ethics committee and the location of the clinical trial institution in 24 hours、Autonomous Region、Food and Drug Supervision and Administration Department and Health and Family Planning Department of the Municipality。For death，Clinical trial institutions and researchers shall provide all the information required to the ethics committee and applicants。

Article 72 Researchers shall record all bad events and device defects found in the clinical trials，and analyze the cause of the event with the applicant，Form a written analysis report，Put forward to continue、Opinions of Passing or Term Test，The clinical trial management department of the clinical trial institution is reported to the ethics committee for review。

Article 73 Researchers shall guarantee accurate clinical trial data、Full、Clear、Timely loading the case report form。The report form of the case is signed by researchers，The change of any data shall be signed by the researcher and marked the date，Keep the original record at the same time，The original record should be clearly recognizable。

Article 74 The clinical trial institution and researchers shall ensure that the data formed by clinical trials、Files and records、Accurate、Clear、Safety。

Article 75 of the clinical trial institution and researchers shall accept the investigation of the applicant、Check and supervise the Ethical Committee，and provide all the records required for test -related records。Food and Drug Supervision and Management Department、The competent department of health and family planning sent inspectors to conduct inspection，Clinical trial institutions and researchers shall cooperate。

Article 76 The clinical trial institutions and researchers have found that the risk exceeds possible benefits，or the results of the safety and effectiveness of the safety and effectiveness of the medical equipment for testing the test，When you need to suspend or terminate clinical trials，Should notify the subject，and ensure that the subject is appropriate treatment and follow -up，Report in accordance with the regulations at the same time，Provide a detailed written explanation。When necessary，Report Location、Autonomous Region、Food and Drug Supervision and Management Department of Municipality。
Researchers receive notifications to suspend or terminate clinical trials when they receive the applicant or the ethics committee when they receive a notification from the applicant or the ethics committee.，The subject should be notified in time，and ensure that the subject is appropriate treatment and follow -up。

Article 77. Clinical trial institutions and researchers on the tip of the organizer or the request to change the test data、Conclusion，The province of the applicant's location should be、Autonomous Region、Report on the Food and Drug Supervision and Administration of Food and Drugs or State Food and Drugs of the State Food and Drugs directly under the Central Government。

Article 78 at the end of the clinical trial，Researchers should ensure that all records are completed、Report。At the same time，Researchers should also make sure、abandoned or returned quantity is in line with，Make sure the remaining test for medical device is properly handled and records archive。

Article 79 Researchers can according to the needs of clinical trials，Authorized corresponding personnel recruits subjects、Continue communication with the subject、Clinical trial data records、Test medical device management, etc.。Researchers shall conduct relevant training and form a corresponding file。

Chapter 8 Record and Report

Article 80 In clinical trials，Researchers shall ensure that any observation and discovery should be recorded correctly and completely，and carefully fill in the case report form。Records shall include at least:
(1) Information for testing medical devices used in the test，Including names、Model、Specification、Receiving Date、batch number or series number, etc.;
(2) Medical records such as each subject and the progress of the disease、Nursing records, etc.;
(3) Records of testing medical devices for each subject，Including the date of each use、Time、Status of test medical equipment, etc.;
(4) The signature and date of the recorder.

Article 81 Clinical trial records as original information，Do not change it at will; the reason should be explained when it is necessary to make changes，Signature and indicate the date。
Data should be verified for a significant deviation from clinical trial plan or data other than clinical acceptable scope，The necessary instructions for researchers。

Article 82 The applicant shall be accurate、Regular information related to clinical trials，Content includes:
(1) The delivery and processing records of test medical equipment，Including names、Model、Specification、Batch number or serial number，Name of the receiver、Address，Transportation date，Return to repair or clinical trial medical device sample recycling and disposal date、Reason and processing method, etc.;
(2) Agreement signed with clinical trial institutions;
(3) Inspection report and verification report;
(4) Records and reports of severe adverse events and device defects that may cause serious adverse events。

Article 83 Researchers shall in accordance with the design requirements of the clinical trial plan，Verify or confirm the safety and effectiveness of the test medical equipment，Complete clinical trial report。Clinical trial reports of multi -center clinical trials shall contain the clinical trial summary of each branch center。

Article 84 For multi -center clinical trials，Summary clinical trials of each branch center should be at least including clinical trials、Clinical information、Experimental medical devices and information descriptions of medical devices in control、Security and effective data set、The incidence and processing of bad events、Procedure of the scheme departure, etc.，An attached case report form。

Article 85 Clinical trial report shall be consistent with the clinical trial plan，It mainly includes:
(1) General information;
(2) Abstract;
(3) Introduction;
(4) Clinical trial purposes;
(V) Clinical trial method;
(6) Clinical trial content;
(7) Clinical information;
(8) Trial medical devices and control diagnosis methods;
(9) statistical analysis methods and evaluation methods;
(10) Clinical evaluation standards;
(11) The tissue structure of clinical trials;
(Twelve) Ethics description;
(Twelve) Ethics description;
(14) stake online sports bettingThe adverse events found in clinical trials and their treatment situation;
(15) Analysis of the results of clinical trials、Discussion，Especially indications、Applicable range、Contraindications and precautions;
(16) Clinical trial conclusion;
(17) Existing problems and improvement suggestions;
(18) Test personnel list;
(19) Other situations that need to be explained.

Article 86 Clinical trial report shall be signed by researchers、indicate the date，Opinions of the clinical trial management department of the clinical trial institution of the clinical trial institution and issuing opinions、indicates the date and stamped with the seal of the clinical trial agency.。
Multi -central clinical trials，Summary clinical trials of each branch center shall be signed by the researcher of the center and indicate the date，A review by the medical device clinical trial management department of the center of the center、indicate the date and stamp it with the seal of the clinical trial agency.。

Chapter 9 Test Medical Device Management

Article 87 The applicant shall refer to the provisions of the medical device instructions and label management of the State Food and Drug Administration for reference to the State Food and Drug Administration，Appropriate logo for test medical equipment for test，Bad "Test"。

Article 88 The records of test medical devices include production date、Product batch number、serial number, etc. related records related to production，Inspection records related to product quality and stability，Transportation、Maintenance、Delivery records used by clinical trial institutions，and information about recycling and disposal date after test。

Article 89 The use of medical devices for testing is responsible for the use of clinical trial institutions and researchers，Researchers shall ensure that all test medical equipment for tests is only used for the subject of the clinical trial，Medical equipment for storing and storage tests during the test during the test，After clinical trials, it is processed to test medical devices in accordance with relevant national regulations and an agreement with the applicant。The above process must be responsible and recorded by a special person。Researchers must not transfer the test medical equipment to any non -clinical trial participants。

Chapter 10 Basic File Management

Article 90 clinical trial institution、Researcher、Subsiders should establish a basic document storage system。Basic files of clinical trials are divided into three parts according to the clinical trial stage: the preparation stage file、Perform stages and terminate or complete files。

Article 91 The clinical trial institution shall preserve clinical trial materials until the clinical trial is over 10 years。The applicant should save the clinical trial information until it is not used in the medical device。

Article 92 The basic files of clinical trials can be used to evaluate the applicant、The implementation of clinical trial institutions and researchers on the requirements of this specification and the relevant requirements of the food and drug supervision and management department。Food and Drug Supervision and Management Department can check the basic files of clinical trials。

Chapter 11 Attachment

Article 93 The meaning of the following terms in this specification:
Medical Device Clinical Test Institution，refers to a medical institution that is recognized by the State Food and Drug Administration and the National Health and Family Planning Commission.。If there is no special explanation，The "clinical trial institution" in this specification refers to the "medical device clinical trial institution"。
Trial medical equipment，refers to the safety of it in clinical trials、Performators to confirm or verify medical devices to be registered for registration。
Applicants，refers to the launch of clinical trials、Management and financial support institutions or organizations。
Researcher，refers to those who are responsible for the implementation of clinical trials in clinical trial institutions。If a group of personnel are implemented in the clinical trial institution，Researchers refer to the person in charge of the group，Also known as the main researcher。
Ethics Committee，refers to an independent institution that reviews the scientific and ethicality of clinical trial projects set by clinical trial institutions。
Medical Device Clinical Test Management Department，refers to the offices or departments responsible for the management and quality control of clinical trials in clinical trial institutions。
Multi -central clinical trial，refers to according to the same clinical trial scheme，Clinical trials implemented by more than three (including three) clinical trial institutions。
A subject，refers to the individual who was recruited by clinical trials of medical equipment。
Knowing consent，refers to the situation of informing the subject in all aspects of clinical trials，The subject confirmed that the process of voluntary participation in this clinical trial，It should be used as a proof file with the informed consent of the signature and indication date。
Knowledge Agreement，Refers to the proof file of the subject's voluntary participation in clinical trials。
Inspection，refers to the clinical trials that the applicant can carry out the clinical trials to ensure the development of the clinical trials、Standard Operation Regulations、This specification and applicable management requirements，Select special personnel for the clinical trial institution、Researchers conduct an evaluation survey，Verify and record and report the data in the clinical trial process。
Inspector，25305_25333。
Check，refers to a systematic independent examination of clinical trial -related activities and documents organized by the organizers，To determine the execution of such activities、Data records、Analysis and report whether it meets the clinical trial plan、Standard Operation Regulations、This specification and applicable management requirements。
Inspector，。
Check，refers to the relevant documents of the regulatory department for clinical trials、Facilities、Records and other aspects of supervision and management activities。
Inspector，refers to the personnel selected by the regulatory department to check the medical device clinical trial project。
Disting，refers to the situation that intentionally or unintentionally follows the requirements of the clinical trial plan。
Case Report Form，refers to the file designed in accordance with the clinical trial plan，Used to record all the information and data obtained by each subject obtained during the test。
End point，refers to an indicator used to evaluate the hypothesis of clinical trials。
Source data，refers to clinical discovery in clinical trials、Observation and original records of other activities and all information in its approved copy，Can be used for clinical trial reconstruction and evaluation。
Source file，refers to the printing file containing source data、visible files or electronic files, etc.。
Bad events，refers to unfavorable medical events that occur during clinical trials，Whether or not it is related to test medical equipment。
Severely bad events，refers to the severe deterioration of death or health during clinical trials，Including fatal diseases or damage、Permanent defects of body structure or physical function、Need to be hospitalized or extend the hospitalization time、Need medical or surgical intervention to avoid permanent defects caused by physical structure or physical function; cause fetal distress、Fetal death or congenital abnormality、Congenital defects and other events。
Equipment defects，refers to the unreasonable risk of Chinese medicine treatment equipment in the clinical trial process under normal use.，If a label error、Quality Question、Failure, etc.。
Standard Operation Regulations，refers to the standards and detailed written rules prepared by each work in the clinical trials。
Clinical data，refers to the safety obtained in the clinical use of relevant literature or medical equipment、Performance information。

Article 94 The format of the format of the approved application for clinical trial ethics for medical devices is formulated by the State Food and Drug Administration。

Article 95 This specification is not suitable for in vitro diagnostic reagents that are managed in accordance with medical equipment。

Article 96 This specification will be implemented from June 1, 2016。The Regulations on the Clinical Test of the Medical Devices released on January 17, 2004 (State Food and Drug Administration Order No. 5) at the same time abolished。