Chapter 1 General Principles
1 to ensure the clinical trial process specifications of the drug，Science and reliable results，Protect the rights and interests of the subject and protect its safety，According to the "Drug Management Law of the People's Republic of China"、The Implementation Regulations of the Drug Administration Law of the People's Republic of China，Refer to the internationally recognized principles，Develop this specification。
Article 2 Drug Clinical Test Quality Management Specifications are the standards of the entire process of clinical trials，Including solution design、Organization Implementation、Monitoring、Inspection、Record、Analysis and summary and report。
Article 3 All the clinical trials of each phase、Human biological utilization or biological equivalent test，All must be implemented in accordance with this specification。
Article 4 All research with human -oriented objects must meet the "World Medical Conference Herxia Declaration" (Appendix 1)，Just as fair、Respect personality、Strive to make the subjects to maximize and avoid damage as much as possible。
Chapter 2 Preparation and necessary conditions before clinical trials
5 The clinical trials of the drug must have sufficient scientific basis。Before the human body test，Must considers the purpose of the test and the problem to be solved，Should weigh the benefits and risks of the expected expectations of the subject and public health，The expected benefit should exceed possible damage。Selecting clinical trial methods must meet science and ethics requirements。
Article 6 Clinical trial drugs are prepared and provided by the applicant。Before clinical trials，Applicants must provide pre -clinical research information for test drugs，Including prescription composition、Manufacturing process and quality inspection results。Preparence information provided by provided must meet the requirements of the corresponding clinical trials for each period of clinical trials，At the same time, the test drugs have been provided with effective and safety data related to clinical trials.。Preparation of clinical trial drugs，It should be in line with the "Specifications for the Management of Drug Production Quality"。
The facilities and conditions of the drug clinical trial institution shall meet the needs of the clinical trials for safe and effective clinical trials。All researchers should have a professional expert that undertakes this clinical trial、Qualification and ability，and after training。Before the clinical trial starts，Researchers and applicants should test the plan、Inspection of the test、Inspection and standard operating procedures and the division of responsibilities in the test reached a written agreement。
Chapter 3 The Rights Protection of the subject
Article 8 In the process of clinical trials of the drug，must be fully guaranteed to the personal rights and interests of the subject，Make sure the scientific and reliable test of the test。The rights of the subject、Safety and health must be higher than the consideration of scientific and social interests。Ethics Committee and informed consent is the main measure to protect the rights and interests of the subjects。
1 to ensure the rights and interests of the subjects in clinical trials，Must establish an independent ethics committee，and filed with the State Food and Drug Administration。Ethics Commission should engage in pharmaceutical -related professionals、Non -medical professionals、Legal experts and personnel from other units，At least five people compose，also members with different gender。The composition and work of the Ethical Committee should not be affected by any participation test.。
Article 10 The test plan shall be reviewed and agreed by the Ethics Committee and signed the approval opinion.。During the test，Any modification of the experimental scheme shall be approved by the Ethical Committee; serious adverse events in the test，Report to the Ethics Committee in time。
Article 11 The review opinions of the Ethical Committee on the clinical trial plan shall make a decision after discussion，Members participating in the clinical trial should avoid。A non -commissioned experts can be invited to attend the meeting due to work needs，but not voting。The Ethical Committee should establish a working procedure，All meetings and their resolutions should have written records，Records preserved to five years after clinical trials。
Article 12 The Ethical Committee shall strictly follow the following review test schemes from the perspective of protecting the subject's rights:
(1) Eligibility of researchers、Experience、Whether there is enough time to participate in clinical trials，Whether the personnel equipment and equipment conditions meet the test requirements;
(2) Whether the test plan fully considers ethical principles，Including research purposes、The scientific nature of the risks and benefits and test design that the subject and other personnel may suffer;
(3) The method selected by the subject，To the subject (or its family、Guardian、Legal agent) Provides whether the information about this test is complete and easy to understand，Whether the method of obtaining the consent of knowledge is appropriate;
(4) The subject was damaged or even killed due to participation in clinical trials，treatment and/or insurance measures given;
(5) Whether the amendment opinion proposed by the test plan is acceptable;
(6) Regularly review the risk of the subject during the clinical trial。
Article 13 The Ethical Committee shall hold a meeting in time after receiving the application，Review Discussion，Send written opinion，and attached a list of members attending the meeting、Professional situation and my signature。The opinions of the Ethical Committee can be:
(1) Agree;
(2) Agreement after the necessary correction;
(3) Disagree;
(4) Termination or suspension of approved tests.
Article 14 Researchers or representatives they specified must explain to the subject's detailed situation of clinical trials:
(1) The subject participating in the test should be voluntary，And there is the right to quit the test at any time at any stage of the test without being discriminated against or retaliated，Its medical treatment and equity will not be affected;
(2) Must be understood by the subject，Participating in the test and the personal information in the test is confidential。When necessary，Drug Supervision and Management Department、Ethics Committee or applicant，According to the regulations, you can check the information of the subjects participating in the test;
(3) Test purposes、The process and period of the test、Check operation、The subject expects possible benefits and risks，Inform the subject that may be assigned to different groups of the test;
(IV) Give the subjects to be fully time to consider whether they are willing to participate in the test，A subject who fails to express consent，Should provide the above introduction and instructions to its legal agent。The process of informed consent should be understood by the language and text that the subject or the legal agent can understand，During the trial，The subject can understand the information related to it at any time;
(5) If the damage related to the test occurs，The subject can get treatment and corresponding compensation。
Article 15 After fully and detailed explanation tests, obtaining informed consent:
(I)，Researchers who perform the process of knowing the consent of the informed consent also need to sign the name and date on the informed consent letter;
(2) A subject with no behavior，If the Ethics Committee agrees in principle、Researchers believe that when the subjects participating in the test meet their own interests，Then these patients can also enter the test，At the same time, it shall be agreed with its legal guardian to sign and sign and indicate the date;
(3) Children as subjects，It is necessary to obtain the consent of the legal guardian and sign the informed consent，When a child can make a decision to agree to participate in the study，It must also obtain its own consent;
(4) In emergency circumstances，Can't obtain the informed consent of my and their legal representatives，If there is a lack of proven effective treatment methods，Test drugs are expected to save life，Restore health，or reduce the pain，Considering as a subject，But you need，and obtained the consent of the Ethics Committee in advance;
(5) If the important new information involved in testing drugs is found, it is necessary to make a written modification of the informed consent.，Get the subject consent again。
Chapter 4 Test Plan
Article 16 The test plan shall be formulated before the beginning of the clinical trials，This scheme shall be agreed and signed by the researchers and the applicant，Report the Ethical Committee for approval。
Article 17 The clinical trial plan shall include the following:
(1) Test questions;
(2) Test purposes，Test background，Discovery of clinical significance in preclinical research and clinical trial results related to the test、It is known that the possible danger and benefit of the human body，and the possibility of human differences in test drugs;
(3) The stake sports betting appname and address of the applicant，Places to test，Researcher's name、Qualification and address;
(4) Types of test design，Randomized grouping method and level of blindness;
(5) Selected criteria for subjects，Elimination standards and excluding standards，Steps to select the subject，Methods assigned by the subject;
(6) Calculate the number of cases required for the expected purpose of the test according to statistical principles;
(7) The dosage form of the test medicine、Dose、Drug pathway、Drug method、Number of administration、Regulations on the course of treatment and related medication，and explanation of packaging and labels;
(8) Projects planned to conduct clinical and laboratory examinations、The number of measured and the analysis of pharmacokinetics, etc.;
(9) Registration and use of drugs for testing drugs、Delivery、distribution method and storage conditions;
(Ten) Clinical Observation、Measures for follow -up and guarantee the compliance of the subject;
(11) Standards for clinical trials，The provisions of the clinical trial end;
(Twelve) Standards for Efficacy Efficiency，Methods to evaluate parameters、Observation time、time and return;
(13) Coding of the subject、Save procedures for random digital tables and case report tables;
(14) Record requirements and reporting methods for bad events and serious adverse events、Treatment measures、Method of follow -up、time and return;
(15) The establishment and preservation of drug codes for testing，The rules of breaking blindness in the case and emergency;
(16) Statistical Analysis Plan，The definition and selection of statistical analysis data sets;
(17) Regulations of data management and data traceability;
(18) Quality control and quality assurance of clinical trials;
(19) Test -related ethics;
(20) The progress and completion date of clinical trial expectations;
(21) follow -up and medical measures after the test;
(22) responsibilities and other relevant regulations of all parties;
(23) Reference.
Article 18 of clinical trials，If necessary，You can correct the test plan in accordance with the prescribed procedures。
Chapter 5 Researchers' responsibilities
Article 19 Researchers responsible for clinical trials shall have the following conditions:
(1) Have corresponding professional and technical positions in medical institutions and qualifications for medical practice;
(2) The professional knowledge and experience required in the experimental scheme;
(3) The clinical trial method has rich experience or can obtain the academic guidance of researchers with experience in the unit;
(4) Familiar with the information and documents related to clinical trials provided by the applicant;
(5) I have the right to dominate the person involved in the test and the equipment required to use the test。
20 Researchers must read and understand the content of the test scheme in detail，and strictly follow the scheme。
21 Researchers shall understand and be familiar with the nature of test drugs、Function、curative effect and safety (including the relevant information of the pre -clinical study of the drug)，At the same time, you should also master all new information related to the drug during clinical trials。
Article 22 Researchers must have good medical facilities、Laboratory equipment、Medical institutions equipped with personnel for clinical trials，The agency should have all facilities that deal with emergencies，to ensure the safety of the subject。The results of laboratory inspections should be accurate and reliable。
Article 23 Researchers shall get the consent of the medical institution or competent unit where the medical institution or competent unit is located，It is guaranteed to be responsible for and complete the clinical trial within the period specified in the scheme。Researchers must explain the information about the experiment to all staff participating in clinical trials、Regulations and responsibilities，Make sure that the subjects with sufficient number and meet the test plan entered the clinical trial。
Twenty -four Researchers shall explain to the subject's detailed situation of the test with the consent of the ethics committee，and Get Knowledge Agreement。
Article 25 Researchers are responsible for making medical decisions related to clinical trials，It is guaranteed that the subjects will get appropriate treatment when there are adverse events during the test。
Article 26 Researchers have the obligation to take necessary measures to ensure the safety of the subject，recorded in the case。If severe adverse events occur during clinical trials，Researchers should immediately take appropriate treatment measures to the subjects，Report the drug supervision and management department at the same time、Health Administrative Department、Applicants and Ethics Committee，and signature and indicating the date on the report。
27 Researchers shall guarantee that the data is true、Accurate、Full、Timely、Law loading of medical records and case reports。
28 Researchers shall accept the inspection and inspection and inspection of the inspection and inspection by the inspectors or audit and management departments sent by the applicant，Ensure the quality of clinical trials。
Article 29 Researchers shall agree with the applicant's cost of clinical trials，and stated in the contract。Researchers during clinical trials，The cost required for the test for the subject must not be charged to the subject。
Article 30 After the clinical trial is completed，Researchers must write a summary report，Signature and indicate the application after the date。
Article 31 Researchers must notify the subject with a clinical trial to stop a clinical trial、Applicants、Ethics Committee and Drug Supervision and Administration Department，Claim the reason。
Chapter VI's responsibilities
Article 32: The applicant is responsible for initiating、Application、Organization、Inspection and audit A clinical trial，Provide test funds。Applicants are according to national laws、Regulations, regulations, etc.，Application for clinical trials to the State Food and Drug Administration，You can also entrust the contract to study some tasks and tasks in clinical trials。
Article 33 Institutions and researchers for choosing clinical trials，Recognize its qualifications and conditions to ensure the completion of the test。
Article 34 Specialist provides researchers' manual，Its content includes the chemistry of the test drug、Pharmacy、Toxicology、Pharmacology and clinical (including previous and undergoing tests) information and data。
Article 35: The organizers can organize clinical trials after obtaining the approval of the State Food and Drug Administration and obtaining the approval of the Ethics Commission。
Article 36 Specialist、Researchers jointly design the clinical trial plan，Shimped in the implementation of the plan、Data Management、Statistics analysis、Result report、Publishing the papers and other responsibilities and division of labor。Signed the test plan and contract that the two parties agreed with。
Article 37: Specialists provide researchers with easy recognition、Test drugs with correct coding and special labels、Standard products、Control medicine or placebo，And guarantee the quality qualification。Trial medicines should be appropriately packaged according to the needs of the test plan、Save。The applicant should establish a management system and record system for testing drugs。
Article 38 of the organizer appointed qualified monitor，and accepted by researchers。
Article 39 Specialty shall establish the quality control and quality assurance system for clinical trials，Organizational audit on clinical trials to ensure quality。
Article 40 The applicant shall quickly and and the researcher should quickly develop a serious adverse event，Take necessary measures to ensure the safety and rights of the subject，Report to the drug supervision and management department and the health administrative department in time，Simultaneous report to other researchers involved in clinical trials involving the same drug。
Article 41 The organizer is suspended before a clinical trial，It is necessary to notify the researcher、Ethics Committee and the State Food and Drug Administration，Terminal reasons。
Article 42: Specialist is responsible for submitting a summary report of the test to the State Food and Drug Administration。
Article 43 Substitutors provide insurance with subjects participating in clinical trials，The cost of treatment for the treatment of the subject who is related to the experiment or the corresponding economic compensation。The applicant shall provide researchers with legal and economic guarantee，But except for medical accidents。
Article 44 Researchers do not comply with approved plans or relevant regulations for clinical trials，The applicant should point out to correct it，If the situation is serious or insist on not changing，then the researchers should end the clinical trial and report to the drug supervision and management department。
Chapter 7 The responsibility of the monitor
Article 45 The purpose of monitoring is to ensure that the rights and interests of the subjects in clinical trials are guaranteed，The data of the test record and report is accurate、Completely without errors，Make sure the test follows the approved scheme and relevant regulations。
Article 46 Inspectors are the main contacts between the applicant and the researcher。The number of people and visits depends on the complexity of clinical trials and the number of medical institutions participating in the test。Inspectors should have appropriate medicine、Pharmacy or related professional education，and after necessary training，Familiar with the relevant regulations of drug management，Familiar with the clinical pre -clinical and clinical information of test drugs and clinical trial solutions and related documents。
Article 47 Inspectors shall follow the standard stake betting appoperating regulations，Supervise My stake betting appthe clinical trial，To ensure clinical trials performed according to the scheme。The specific content includes:
(1) Confirm that the test undertaking unit already has appropriate conditions，Including personnel equipment and training，Laboratory equipment is complete、Good operation，Have various test conditions related to test，It is estimated that there are sufficient number of subjects，Participating in the requirements of the researchers familiar with the requirements in the test plan;
(2) During the experiment，Confirm that obtaining the knowledge consent of all the subjects before the test，Understand the selection rate of the subject and the progress of the test，Confirm that the selected subject is qualified;
(3) Confirm that the records and reports of all data are correct and complete，All case 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 indicate the date。Dose changes in each test person、Treatment change、Medicine for merging、Diseases、Out of an interview、Checking omissions, etc., should be confirmed and recorded。A verification of the withdrawal of the selected subjects has been explained in the report form of the case;
(4) Confirm that all adverse events are recorded in the case，Severe adverse events reported and recorded in the case within the specified time;
(5) A verification of the test medicine for testing is supplied in accordance with relevant regulations、Storage Tibetan、distribution、Recovery，and do the corresponding records;
(6) Assist the researchers to conduct necessary notifications and applications，Report the test data and results to the applicant;
(7) Should clearly record the follow -up of the researchers that the researchers failed to do、Unporing tests、Not done inspection，or not right、omissions to correct;
(8) Send a written report to send a bid for a written report every time you visit，The report should be described in the Ming Dynasty Supervision Date、Time、Inspector name、Inspection discovery, etc.。
Chapter 8 Record and Report
Article 48 of the medical records as the original file of clinical trials，Should be completely stored。The data in the report form of the case comes from the original file and consistent with the original file，Any observation in the test、The results of the inspection should be timely、Accurate、Full、Specification、Really recorded in the medical records and correctly fill in it in the case report form，You must not change at will，Indeed to fill in errors，To make any correction, the original record should be clearly argued，Name and time signed by the correctioner。
Article 49 The data of various laboratories in clinical trials shall record or paste the original report copy on the case report form，Data in the normal range should also be recorded。Data from significantly deviated or in the scope of clinical acceptance must be verified。The test items must indicate the measured unit。
Article 50 to protect the privacy of the subject，The name of the subject should not appear on the report form of the case。Researchers should confirm their identity according to the code of the subject and record。
Article 51 The content of the clinical trial summary report shall be consistent with the requirements of the test plan，Including:
(1) Randomly enter the actual cases of each group，cases and reasons for falling and eliminated;
(2) The baseline feature comparison between different groups，to determine comparableness;
(3) Statistical analysis and clinical analysis of all curative effect evaluation indicators。The explanation of statistical results should be considered its clinical significance;
(4) Safety evaluation should have a statistical analysis of clinical adverse events and reasonable laboratory indicators，Detailed description and evaluation should be described and evaluated for serious adverse events;
(5) Multi -center test evaluation efficacy，Considering the differences and influence between the center of the center;
(6) Make a brief overview and discussion on the efficacy and safety of test drugs and the relationship between risks and benefits。
Article 52 The data in clinical trials must be stored in accordance with regulations (Appendix 2) and Management。Researchers should preserve clinical trial information until the clinical trial termination five years。The applicant should save the clinical trial data until the test drug is approved five years。
Chapter 9 Data Management and Statistical Analysis
Article 53 The purpose of data management is to quickly the test data、Full、Incorporate it into the report，All steps involved in data management need to be recorded in the case，In order to check the quality and test of the data。Use appropriate procedures to ensure the confidentiality of the database，It should have the maintenance and support program of the computer database。
Article 54 The allocation of subjects in clinical trials must be performed according to the random distribution scheme determined by the test design，The processing packet coding of each subject should be kept as a blind bottom.。A blind trials should specify the conditions of the blindness and procedures for the enforcement of blindness，Emergency letter with corresponding processing codes。In emergency circumstances，Allows to urgently break the blind and understand the treatment they accept for individual subjects，But the above reasons must be reported in the case report form。
Article 55 The statistical analysis process of clinical trial data and the expression of the results must be used with standardized statistical methods。Clinical trials are required to participate in biological statistical professionals in each stage。The statistical analysis plan is needed in the clinical trial plan，and confirm and refine it before formal statistical analysis。If you need to make a medium -term analysis，Explanation of reason and operating procedures。The evaluation of the treatment role should be considered with the results of the trusted interval with the results of the hypothetical test。The statistical analysis data set selected needs to be explained。For missing、Unsusted or extra information must be explained，The statistical report of clinical trials must be consistent with the clinical trial summary report。
Chapter 10 Test Drug Management
Article 56 Drugs for clinical trials shall not be sold.
Article 57 Specialist is responsible for making appropriate packaging and labels on clinical trial medicines，and indicated as a clinical trial for。In the double -blind clinical trial，Test drugs and controlled drugs or placebo in appearance、Smell、Packaging、Tags and other features should be consistent。
Article 58 The use of test drugs shall include quantity、Liencing、Delivery、Accept、allocation、Information from the recycling and destruction of the remaining drugs after application。
Article 59 The use of test drugs is responsible for the use of the drug，Researchers must ensure that all trial drugs are only used for the subject of the clinical trial，The dose and usage should follow the test plan，The remaining trial drugs will return to the applicant，The above process must be responsible and recorded in the case，Test medicines must be managed by someone with special person。Researchers must not transfer the test drugs to any non -clinical trial participants。
Article 60 The supply of drugs for test medicine、Use、The processing process of storage and remaining drugs should be checked by relevant personnel。
Chapter 11 Quality Assurance
Article 61 Specialists and researchers shall perform their respective responsibilities，Strictly follow the clinical trial plan，Use standard operation rules，To ensure the quality control and quality assurance system of clinical trials。
Article 62 The results and discoveries of all observations and discoveries in clinical trials shall be verified，Mass control must be performed at every stage of data processing，To ensure complete data、Accurate、True、Reliable。
Article 63 Drug Supervision and Administration Department、Applicants can entrust inspectors to conduct a systematic inspection of clinical trial -related activities and documents，Whether the test test is based on the test plan、Standard operating procedures and relevant regulations requirements，test data is timely、True、Accurate、Records complete。The inspection shall be performed by the person who does not directly involve the clinical trial。
Article 64 The drug supervision and management department should inspect the researchers and the applicants' respective tasks and execution status in the implementation test。The relevant information and documents (including medical records) of the medical institutions and laboratories participating in clinical trials should be inspected by the drug supervision and management department。
Chapter 12 Multi -Center Test
Article 65 Multi -Center Test is a clinical trial carried out by multiple researchers according to the same test scheme in different places and units。Each center begins with the test。Multi -center test is always responsible for a main researcher，Coordinated researchers among the centers of clinical trials。
Article 66 The planning and organizational implementation of multi -center tests must be considered:
(1) The test scheme is discussed and determined by the main researchers of each center and the applicant，Ethical Committee approved after approval;
(2) Organizing researcher meetings at the beginning of clinical trials and the mid -term should be organized;
(3) All centers conducted clinical trials at the same time;
(4) The size of the clinical trial samples of each center and the distribution between the center should meet the requirements of statistical analysis;
(5) It is guaranteed，Including distribution and storage;
(6) Researchers who participated in the Stake Sports Bettingtest according to the same Stake Sports Bettingexperimental scheme training;
(7) Establish a standardized evaluation method，The laboratory and clinical evaluation methods used in the test should have a unified quality control，Laboratory inspection can also be performed by the central laboratory;
(8) The data should be centralized and analyzed，Data transmission should be established、Management、Check and query procedure;
(9) Guarantee that researchers of each test center follow the test plan，Including termination of its participation test when violating the plan。
Article 67 The multi -center test shall be based on the number of centers and tests participating in the test，and establish a management system for understanding the degree of understanding medicine，Coordinating researchers are responsible for the implementation of the entire test。
Chapter 13 Attachment
Article 68 The meaning of the following terms in this specification is:
ClinicaltrictRial，Refers to the systemic research of any drug in the human body (patient or healthy volunteer)，To confirm or reveal the role of the test drug、Adverse reactions and/or test drug absorption、Distribution、metabolism and excretion，The purpose is to determine the efficacy and safety of test drugs。
Test scheme (Protocol)，Theoretical foundation and purpose、Theoretical foundation and purpose，Test Design、Methods and Organization，Including statistical consideration、Testing and completion conditions。The scheme must be the main researcher participating in the test、Signing seal of research institutions and applicants。
Researcher Handbook (Investigator，sBrochure)，It is the existing clinical and non -clinical research data of the test drugs when conducting human research。
InformedConsent，Pind to inform the subject in all aspects of the test，The subjects voluntarily confirmed that they agreed to participate in the clinical trial process，The informed consent of the signature and the date of indicating the date must be used as a file proof。
InformedConsEntform，It is a document for each subject to voluntarily participate in a test of a test。Researchers need to explain the test nature to the subject、Test purposes、Possible benefits and risks、Other treatment methods available and the rights and obligations of the subjects that comply with the Herbinji Declaration，Expressing its consent after fully understanding the subject。
EthicsCommittee，Due to medical professionals、Independent organization composed of legal experts and non -medical personnel，Its responsibility is to verify whether the clinical trial plan and attachments are moral，and provide public guarantee for it，Ensure the safety of the subject、Health and equity is protected。The composition of this committee and all activities should not be interfered or influenced by clinical trial tissue and embodiment。
Investigator，It is responsible for the quality of clinical trials and the quality of clinical trials and the safety and rights of the subjects。Researchers must be reviewed by qualification，Professional expertise with clinical trials、Qualification and ability。
Coordinated researcher (coordinatinginVestigator)，In the multi -center clinical trial, responsible for coordinating a researcher who participated in the work of various central researchers。
SPonsor (sponsor)，Initiating a clinical trial，and start the test、Management、Company responsible for finance and monitoring、Organization or Organization。
Monitor (Monitor)，Persons who are appointed by the applicant and are responsible for the applicant，The task is to perform the situation and verify data of the inspection and report test。
Audit (Audit)，refers to a systematic inspection performed by those who do not directly involve the test，Implementation of evaluation test、Data records and analysis whether it is with the test scheme、Standard operating procedures and the requirements of drug clinical trials are consistent。
Inspect (inspect)，Drug Supervision and Administration Department on a clinical trial related documents、Facilities、Records and other aspects to conduct official review，Inspection can be in the test unit、The location of the applicant's or contract research organization is performed。
CasereportForm,CRF)，refers to a file designed according to the test plan，used to record the data of each subject during the test。
InvestigationAlPRODUCT，Test drugs used in clinical trials、Control medicine or placebo。
AdverseeEvent，Patients or clinical trial subjects accept a bad medical event after receiving a drug，but it is not necessarily a causal relationship with treatment。
SeriousadverseEvent，Inpatient treatment occurs during clinical trials、Extend the hospital for hospitalization、Disabled、Affecting work ability、Lives Life or Death、Cause incidents such as congenital deformities。
Standard operating procedures,SOP)，The standards and detailed written procedures prepared by each work in a clinical trial。
Blind/Masking，In clinical trials, make one or more parties do not know the procedures for the treatment and distribution of the subject。Single -blind refers to the subject, I don’t know，Double -blind refers to the subject、Researcher、Inspectors or data analysts do not know the treatment distribution。
Contract Research Organization (Contractresearchorganization,CRO)，A academic or commercial scientific institution。The applicant can entrust them to perform certain tasks and tasks in clinical trials，This kind of commission must make a written rule。
Article 69 This specification is explained by the State Food and Drug Administration。
Article 70 This specification will be implemented from September 1, 2003，Former Drug Administration of Pharmaceutical Supervision and Administration of Drug Administration on September 1, 1999, "Regulations for the Management of Drug Clinical Test Test" at the same time。
Appendix 1:
The World Medical Conference Herbinji Declaration
Ethics criteria for ergonomic research
Through: 18th World Medical Conference，Herbiny，Finland。June 1964
Amendment: The 29th World Medical Conference，Tokyo，Japan，October 1975
The 35th World Medical Conference，Venice，Italy，October 1983
The 41st World Medical Conference，Hong Kong，September 1989
The 48th World Medical Conference，South Africa，October 1996
52nd World Medical Conference，Edinburgh，Scotland，October 2000
I. Foreword
1. The Herbinky Declaration drafted by the World Medical Conference，It is a statement of ergonomic research ethical standards，Used to guide doctors and other participants to conduct ergonomic research。Endmological research includes research on human body and related data or data。
2． Promoting and protecting human health is the responsibility of doctors。Doctor's knowledge and morality is to fulfill this responsibility。
3. The Geneva Declaration of the World Medical Conference is restrained to doctors with a language such as "the health of the patient must be the first to consider"。International Guidelines for Medical Ethics announced: "Only when it is in line with the interests of patients，Doctors can provide medical measures that may adversely affect the physiology and psychology of patients "。
4. The progress of medicine is based on research，These studies eventually depend on the test of people as a subject with people。
5． In ergonomic research，The consideration of the health of the subject should be given priority in science and society。
6. The main purpose of ergonomic research is to improve prevention、Diagnosis and treatment method，Improve the understanding of the cause of disease and pathogenesis。Even the best prevention that has been confirmed、Diagnosis and treatment methods should be continuously examined to test its effectiveness、Efficiency、feasibility and quality。
7. In the current medical practice and medical research，Most of the prevention、Diagnosis and treatment contain risks and burdens。
8. Medical research should follow ethical standards，Respect and protect their health and rights。Some test groups are disadvantaged groups need to be specially protected。Must recognize the special needs of people who are in unfavorable status in economics and medical care。Pay special attention to those subjects who cannot make or reject the consent of informedness、Maybe a subject who knows only under the coercion、From the research, I ca n’t get the subjects who have benefited and the subject who receives treatment at the same time。
9． Researchers must know the country's ethics about human research、requirements of laws and regulations，and meet international requirements。Ethics of any country、Laws and regulations are not allowed to reduce or cancel the protection of the subject specified in this declaration。
2. Basic principles of medical research
10． In medical research，Protect the life and health of the subject，Maintaining their privacy and dignity is the responsibility of a doctor。
11. Body medical research must follow the generally accepted scientific principles，Based on a comprehensive understanding of scientific literature and related materials and full laboratory tests and animal tests (if necessary)。
12. It is necessary to properly implement research that may affect the environment，and respect the rights of experimental animals used for research。
13. The design and implementation of each human test should be clearly explained in the test plan，and the test plan shall be submitted to the Ethical Approval Committee for review、Comments、Guidance，Under the appropriate case，Review and approval。This ethics committee must be independent of researchers and applicants，and is not affected by any other aspects。This ethics committee shall comply with the legal and system of the country where the country is located。The committee has the right to supervise the test。Researchers have the responsibility to submit monitoring information Stake Sports Bettingto the committee，Especially stake betting appthe information of all serious bad events。Researchers should also submit other information to the committee to prepare for approval，Including relevant funds、Applicants、Research institutions and other potential interest conflicts or encouragement information to the subjects。
14. The research plan must be described in ethical considerations，also shows that the plan conforms to the principles stated in this declaration。
15. Body medical research can only be carried out by professional qualifications and under the guidance and supervision of clinical medical experts。It must always be the medical person who is qualified to be responsible for the subject，instead of being responsible for the subject himself，Even if the subject already knows the consent to participate in this study。
16. Before each ergonomic research starts，It should first carefully evaluate the expected risk of the subject or other personnel、Crack and benefit ratio。This does not rule out health subjects to participate in medical research。All research design should be publicly available。
17. Doctors can only conduct this human research only when they are convinced that they can fully foresee the risks in the experiment and can be handled well。If the risk exceeds possible benefits or has a positive conclusion and favorable results, the doctor should stop research。
18. Body medical research can only be carried out when the test purpose exceeds the risk and burden of the subject itself。This is especially important for the subject when the subject is healthy volunteers。
19. Medical research can only be carried out when the test people can benefit from the results of the research。
20. The subject must be voluntary participation and have a full understanding of the research project。
21. Must always respect the rights of the subject to protect themselves。Take as much as possible to respect the privacy of the subject、Patient information is kept secret and reduced the impact on the body and spirit of the subject to the minimum。
22. In any human research, the purpose of the research should be fully inform of the purpose of the research candidate、Method、Source of funds、Possible conflicts of interest、Researchers where researchers are located、Research expected benefits and potential risks, as well as possible discomfort。Should be informed that the subject has the right to refuse to participate in the test or withdraw from the test at any time and will not be revealed。After confirming that the subject understands this information，Doctors should obtain the informed consent given by the subject，It is advisable to be written in writing。If you can't get a written consent form，then the process of obtaining the non -written consent must be recorded and witnessed。
23. When obtaining the consent of the research project，Pay special attention to whether the subjects and doctors have dependent relationships or may be forced to agree to participate。In this case，The acquisition of informed consent shall be fully understood by doctors who have fully understood but do not participate in this study and have no dependence with the subject.。
24． Not qualified in law，Body or mental condition is not allowed to give informed consent，or research subjects of minors，Researchers must follow relevant laws，Obtaining informed consent from its legal representative office。Only the research is necessary to promote the health of the group they represent，or when you cannot do it in the legal qualified crowd，These people can be included in research。
25. When an unqualified subject，If a minor child，Actually you can make a decision for participating research，Researchers Apart from the consent of the legal authorized representative，It must also get my consent。
26. Some studies cannot be agreed from the subject，Including the client or the previous consent，Only when the subject/mental condition of the subject is not allowed to obtain the consent of influence is the necessary feature of this crowd，This study can be carried out。It should be stated in the experimental plan that the special reasons that the subjects who participated in the study could not make the consent，Submit to the Ethics Commission for review and approval。The scheme should also be explained that in the continuing research, you should get knowledge consent from the subjects or legal authorized agents。
27. Both the author and publisher must bear ethical responsibility。When publishing the results of the research，Researchers have the accuracy of the responsibility to ensure the results。The same as the positive result，The negative results should also be published or in other ways to make public。The source of funds should be explained in the publication、Research Affiliated Affairs and any possible conflict of interest。Research reports that do not match the principles published in this declaration cannot be accepted and published。
Third, the additional principles of combining medical research and medical treatment
28. Doctors can combine medical research with medical measures，But only limited to this study has been confirmed to have potential prevention、Diagnosis and treatment value。When the combination of medical research and medical measures，Patients should be protected by additional regulations as subjects of research。
29. The benefits of the new method、Risk、Burial and effectiveness should be with the best prevention with existing existing prevention、Diagnosis and treatment method comparison。This does not exclude that there is no effective prevention at present、Studies in the existence of diagnosis and treatment methods，Use placebo or no treatment as a control。
30. At the end of the study，Each patient's patient should ensure that the most effective prevention that has been confirmed by the study、Diagnosis and treatment method。
31. Doctors should fully inform the patients in the treatment of their patients are related to research。Patients refused to participate in the study should never affect the relationship between the patient and the doctor。
32. In the treatment of patients，For the prevention that has not been proven、Diagnosis and treatment method，Or if it is invalid，If the doctor determines a kind of unconfirmed or new prevention、Diagnosis and treatment methods are expected to save life、Restore health and reduce pain，Under the premise of obtaining the consent of the patient，This method should be used without restrictions。Under possible circumstances，These methods should be used as research objects，And planned to evaluate its safety and effectiveness。Record new information obtained from all related cases，Published at the same time。At the same time, follow other relevant principles of this declaration。
Appendix 2:
Clinical trial saving file
I. Clinical trial preparation stage
Clinical trial Save File Researcher Sollebers
1 Researcher's manual saves
2 Test scheme and its amendment (signature) save the original preservation
3 Case Report Form (Sample Table) Save and save
4 Knowing consent website Save the original saving
5 Financial regulations to save
6 Agreement (Signature) (Signature) (Researcher、Applicants、Contract Research Organization) Save and save
7 Ethics Commission approves the preservation of the original preservation
8 Ethics Committee members Save the original preservation
9 Clinical Test Application Form Save the original
10 Previous laboratory data saving original
11 National Food and Drug Administration approves the preservation of the original
12 Researchers resume and related documents to save the original
13 The laboratory detection of the normal value range related to clinical trials is stored and saved
14 Medical or Laboratory Mass Control Certificate Save the original preservation
15 Test the label of the drug to save the original
Clinical trial Save File Researcher Sollebers
16 Test Drugs and Test Related Materials Reserve Save and Save
17 Test Drugs for drug testing to save the original
18 Set the Blind Broken Rules of Blind Test Save
19 Total random table saves original
20 Inspection Report Save the original
2. Clinical trial stage
Clinical trial Save File Researcher Sollebers
21 Researchers Handbook Update
22 Other files (scheme、Knowledge Agreement、Knowledge Agreement、Notification of written situation) Update saving saving
23 The resume of the new researcher saves the original
24 Medicine、The normal value range of laboratory inspection is updated and saved
25 Test Drugs and Test Related Materials Save and save
26 new batch number test drug prove to be preserved
27 Inspector visits the report to save the original
28 The informed consent of the signature of the signature of the original
29 Primitive medical files Save the original
30 Case Report Form (Fill in，Signature，indicated date) Save the copy to save the original
31 Researchers to give the applicant a serious adverse event report to save the original savings
Clinical trial Save File Researcher Sollebers
32 Subsiders to the Drug Supervision Administration、The serious adverse event report of the Ethical Committee Report to save the original
33 Mid -term or Annual Report Save
34 subjects recognize the code table to save the original
35 A subject screening form and selected table saves
36 Test Drug Registration Form Save
37 Researchers' signature sample saves
Three, after the clinical trial is completed
Clinical trial Save File Researcher Sollebers
38 Test Destruction Certificate Save and Save
39 complete the test subjects encoding directory saving
40 Inspection Certificate Save the original
41 The final surveillance report saves the original
42 Treatment Allocation and Blind Prove to Save the Original
43 test complete report (to the National Food and Drug Administration of Ethics Commission) Save the original
44 Summary Report Save and save the original
