UNOFFICIAL Translation
Good Clinical Practice (GCP)
(August 6, 2003 the State Food and Drug Administration Board Order No. 3 issued; go into effect September 1, 2003)
Chapter I
The first clinical trials of the drug to ensure that the process of specification, the results of scientific and reliable, and protect the rights of subjects to ensure their safety, according to the "Drug Administration Law," "Drug Administration Law Implementation Regulations", referring to the internationally recognized principles and develop the specification.
Article Good Clinical Practice is a standard requirement of clinical trials of the whole process, including program design, organization and implementation, inspection, auditing, recording, analysis and summary reports.
Article III clinical trial where the conduct of each, bioavailability or bioequivalence tests shall be executed in accordance with the specification.
Fourth of all human subjects research must comply with the "World Medical Assembly Declaration of Helsinki" (Appendix 1), namely justice, respect for human dignity, and strive to make the subject as much as possible to maximize benefits and avoid injury.
Preparing Chapter II clinical trials with the necessary conditions
Article clinical drug trials must have sufficient scientific basis. Before human trials, we must carefully consider the purpose and to solve the problem of the test, the subjects should be weighed against the anticipated benefits and public health and risk, should be expected to benefit more than the damage that may occur. Select the method in clinical trials must meet scientific and ethical requirements.
Article clinical trials of drugs prepared by the sponsor and provided. Before clinical trials, the sponsor must provide preclinical drug research data, including prescription composition, manufacturing process and quality test results. Preclinical data provided must comply with a request for the corresponding phases of clinical trials, while also providing experimental drug has completed and ongoing clinical trials and other areas related to the efficacy and safety data. Preparation of clinical trials of drugs, shall comply with "Good Manufacturing Practices."
Article VII of facilities and conditions for clinical test should meet the need for safe and effective in clinical trials. Researchers should have to bear all the clinical trials expertise, qualifications and abilities, and after training. Prior to the start of clinical trials, researchers and sponsors should reach a written agreement on the pilot program, audit testing, inspection and testing standard operating procedures as well as the division of responsibilities.
Protect the interests of the subjects of the third chapter
Article VIII of the drug during clinical trials must be given adequate protection of personal rights of the subjects, and to ensure that scientific and reliability testing. Subjects of rights, health and safety must be considered above the interests of science and society. Ethics Committee and informed consent is the main measures to protect the interests of the participants.
Article IX to ensure that the interests of subjects in clinical trials, to establish an independent ethics committee, and to record the State Food and Drug Administration. Ethics Committee should be engaged in pharmaceutical-related professionals, non-medical professionals, legal experts and personnel from other units, at least five people, and members of different genders. The composition and work of the Ethics Committee should not be affected in any person participating in the trial.
Article X of the protocol by the ethics committee needs to consider the advice agreed upon and signed approval before implementation. During the trial, any changes shall be subject to the approval of the ethics committee of the test program; serious adverse events trials, should be promptly reported to the ethics committee.
Article XI Ethics Committee review comments on the clinical trial program should be discussed by poll after the decision, members participating in the clinical trial should be avoided. Because of their work may invite non-members to attend the meeting of experts, but not to vote. Ethics Committee shall establish procedures, all meetings and resolutions shall have a written record, the record is saved to the end of the five-year clinical trial.
Article XII of the angle of the ethics committee should safeguard the interests of the subjects according to the strict testing program to consider the following:
Qualification (a) researchers, experience, whether there is sufficient time to participate in clinical trials, staffing and equipment conditions, meets the test requirements;
(B) whether the test program fully consider the ethical principles, including research purposes, subjects and others may suffer the risk and benefit from the scientific and experimental design;
(C) the method of subjects enrolled, the participants (or their families, guardians, legal representatives) to provide information about the data from this trial is complete and easy to understand, obtain written informed consent methods are appropriate;
(Four) subjects participating in clinical trials suffered due to the treatment and / or death insurance policy even when the damage occurred, given;
(E) amendments to the proposed trial protocol is acceptable;
(F) periodic review of the level of risk in clinical trials subjects.
Article XIII Ethics Committee after receiving the application shall promptly convene a meeting to discuss the review and issue a written opinion, together with the list of members attending the meeting, professional situation and my signature. Ethics Committee opinion can be:
(A) consent;
(B) make the necessary amendments agreed to;
(C) does not agree;
(D) the termination or suspension of the approved tests.
Article XIV researchers or their designated representative must explain in detail the circumstances of the clinical trials to the subject:
(A) participate in the trial subjects should be voluntary, and the right at any stage of the test and will not withdraw from the trial at any time subject to discrimination or retaliation, their medical treatment and rights will not be affected;
(B) must be made subject to understand, participate in the trial and personal data in the test are confidential. When necessary, the drug regulatory agency, the ethics committee or sponsor, as required to participate in the test subjects can access information;
(C) test purposes, and duration of the test process, check operation, the subjects might be expected to benefit and risk, to inform participants may be assigned to different groups of test;
(D) must be given sufficient time to consider the subjects are willing to participate in the trial, the subjects of the inability to express consent, his legal representative shall provide the above description and explanation. Informed consent process should be able to understand the subject or legal representative language and text, during the test, the subjects can keep abreast of their relevant information;
(E) In the event of trial-related injury, the subject can get treatment and appropriate compensation.
Article XV , after a full and detailed explanation of the test cases to obtain informed consent:
(A) by the subjects or their legal representatives in the informed consent form signed and dated informed consent researchers to perform the process of informed consent is also required to sign in the name and date of the book;
(B) for incapacitated subjects, if the Ethics Committee agreed in principle, researchers believe that when the subjects took the test in line with its own interests, these patients can enter the trial, and should agree and signed by their legal guardian and dated;
(Three) children as subjects, must obtain the informed consent of their legal guardian and signed informed consent, when the child can make a decision to agree to participate in the study, also must obtain their consent;
(D) In case of emergency, you can not get themselves and their legitimate representative of informed consent, as has been proven lack of effective treatment, and the test drug is expected to save lives, restore health, or alleviating the pain, can be considered as subjects person, but requires testing programs and related documents clearly accepted these subjects approach and obtain prior consent of the Ethics Committee;
(Five) found significant new information relating to drug testing must be a written informed consent form sent to the Ethics Committee approved the revised again to obtain consent of the subjects.
Chapter IV test program
Article XVI of clinical trials should be developed before starting the test program, which should be the researcher and sponsor mutually agreed and signed, after the approval of the implementation of the ethics committee report.
Article XVII clinical trial program should include the following:
(A) the test subject;
(B) The purpose of the test, the test background, preclinical studies have found that the trials and the clinical significance of the results of clinical trials, known to be potentially dangerous and benefit the human body, and the existence of ethnic differences in drug trials might;
Name and address of (three) sponsor and conduct the test sites, the researchers name, qualifications and address;
(D) the type of trial design, randomization and blinding method level;
The inclusion criteria (five) subjects, exclusion criteria and exclusion criteria, the selection step subjects, methods subjects assigned;
(F) based on the statistical theory test is expected to reach the required number of cases the purpose;
(Seven) test drug formulations, dosage, route of administration, administration method, the frequency of administration, drug treatment, and provisions relating to the merger, as well as instructions on packaging and labeling;
(H) the proposed clinical and laboratory examination of the project, the number of measured and pharmacokinetic analysis;
(Nine) test drug registration and use of records, delivery, distribution methods and storage conditions;
(Ten) clinical observation, follow-up and compliance measures to ensure the subjects;
(Xi) suspend clinical trials standards, the end of the prescribed clinical trials;
(Xii) The evaluation criteria include evaluation parameter method, observation time, recording and analysis;
Preservation procedures (thirteen) subjects encoded random number table and case report form;
Reporting methods recordkeeping requirements (xiv) adverse events and serious adverse events, treatment measures, follow-up manner, time and fate;
(Fifteen) investigational product coding for the establishment and preservation methods and unblinded case of emergency unblinding requirements;
(Xvi) the statistical analysis plan, statistical analysis and selection of data sets defined;
(Xvii) data management and data traceability requirements;
(Xviii) the quality control and quality assurance of clinical trials;
(Xix) trial-related ethics;
(Twenty) clinical trial progress and expected completion date;
(Xxi) after the end of the trial and medical follow-up measures;
(Xxii) the parties responsibilities and other relevant regulations;
(Xxiii) References.
Article XVIII clinical trials, if indeed there is a need, you can press the prescribed procedures for correction of the test program.
Chapter investigator responsibilities
Article XIX responsible for clinical trial investigator shall meet the following conditions:
(A) have the appropriate professional and technical positions and qualifications to practice in medical institutions;
(B) has the expertise and experience required for the test program;
(C) has extensive experience in clinical trial methodology or the unit can get the guidance of experienced researchers in academic;
(D) be familiar with the clinical trials data and literature provided by the sponsor;
(E) the power to govern the personnel and equipment needed to use the test to participate in the trial.
Diershitiao researchers must carefully read and understand the contents of the test program, and strictly in accordance with the implementation of the program.
Article 21 The investigator should understand and be familiar with the nature of the test drug, effect, efficacy and safety (including information about the pre-clinical studies of the drug), but also should have all found during clinical trials with the drug-related conducted new information.
Twenty-two researchers must have good medical facilities, laboratory equipment, medical staffing agency to conduct clinical trials, the agency should have all the facilities to handle emergency situations to ensure the safety of subjects. Laboratory test results should be accurate and reliable.
Article 23 The investigator should obtain consent where medical institutions or authorities, to ensure that sufficient time is responsible for the completion of clinical trials and programs within the period prescribed. All staff members are required to participate in a clinical trial investigator description of the test data, rules and responsibilities to ensure that a sufficient number of test subjects and meet the program into clinical trials.
Twenty-four researchers should explain the details of the subjects agreed by the ethics committee about the trial and obtain informed consent.
Article 25 The investigator is responsible for making and clinical trials related to medical decisions, to ensure that participants receive appropriate treatment adverse events during the trial.
Twenty-six researchers are obliged to take the necessary measures to ensure the safety of subjects, and for the record. In the clinical trials process, such as serious adverse events, researchers should take immediate appropriate treatment to the subject, while the drug regulatory department report, the health administrative department, the sponsor and the Ethics Committee, and the signature on the report and noted dates.
Article 27 The investigator should ensure that the data is true, accurate, complete, timely, legally loaded records and case report forms.
Article 28 shall be subject to the sponsor investigator dispatched inspectors or inspectors of inspection and auditing departments and Drug Administration inspectors and inspections to ensure the quality of clinical trials.
Article 29 The investigator should agree on costs associated with the sponsor clinical trials, and stated in the contract. Researchers in the clinical trials process, shall not charge fees to drug test required subjects.
Article 30 after the completion of clinical trials, researchers must write the final report, signed and dated evacuation sponsor.
Article 31 suspension of a clinical trial investigator must notify participants, sponsors, ethics committees and drug supervision and management departments, and state the reasons.
Chapter VI of the sponsor's responsibility
Article 32 The sponsor is responsible for initiating, applications, organization, audit and inspection of a clinical trial, and to provide funding for the test. Sponsor in accordance with relevant provisions of national laws, regulations, etc., the State Food and Drug Administration to submit an application for clinical trials, contract research organization can also be commissioned to conduct clinical trials in certain jobs and tasks.
Article 33 The sponsor clinical trials to select institutions and researchers, recognition of their qualifications and conditions to ensure the completion of the trial.