Good Clinical Practice of Pharmaceutical Products [SFDA order No. 3, Effective on September 1, 2003]
Chapter 1: General Provisions
Article 1: This Good Clinical Practice of Pharmaceutical Products (hereinafter “GCP”) is promulgated in accordance with the Drug Administration Law of PRC and Implementing Regulation of Drug Administration Law of PRC, making reference to internationally recognized principles to ensure the standardization of clinical trials of drugs which will result in scientific reliability, and the protection of the interests and safety of the human subject. Article 2: This GCP is a regulation for the standardization of the whole process of a clinical trial, including protocol design, organizing implementation, monitoring, auditing, recording, analysis, summarization and reporting.
Article 3: This GCP is to be observed in all phases of a clinical trial, the bioavailability trial or biological equivalence trial on the human body.
Article 4:All research involving human subjects must conform to the Declaration of Helsinki of World Medical Association (Appendix 1) i.e. fairness, respect of human integrity, maximize the benefits and minimize any harm to the human subject.
Chapter 2: Preparations and Prerequisites
for Conducting a Clinical Trial
Article 5: Sufficient scientific basis must be provided for conducting clinical trials of drugs. The purpose of a clinical trial, the problems to be solved, must be considered before conducting a trial on human subjects. The anticipated benefits and risks for the human subjects and public health must be balanced. The anticipated benefits must exceed the possible harm. The selection of clinical trial methods must conform to scientific and ethical criteria.
Article 6:The drugs to be used in a clinical trial shall be prepared and supplied by the sponsor. Before conducting a clinical trial, the sponsor must provide the pre-clinical study documents, including the formulation, manufacturing process and the quality inspection results of the drug. All pre-clinical study information supplied by the sponsor must conform to the requirements of the respective corresponding phase(s) of the clinical trial. The sponsor shall also provide the documents relating to the effectiveness and safety of the drug obtained from clinical trials already completed or being conducted in other places. GMP shall be conformed for manufacturing the investigational product.
Article 7: The equipment and conditions of the institution where the clinical trial will be conducted shall meet requirements for safety and efficacy.. All investigators shall be qualified for undertaking the trial by their specialty and ability, and have received training. Before starting a clinical trial, a written agreement shall be reached between the investigator and the sponsor upon trial protocol, monitoring, auditing and standard operating procedures, as well as the responsibilities of each party in the trial.
Chapter 3: Protection of a Human Subject’s Interests
Article 8: In a drug clinical trial, the human subject’s interests must be fully protected and the trial shall be scientific and reliable. The human subject’s interests, safety and health must be higher than the consideration for science and social interests. The use of an Ethics Committee and informed consent form are important methods to protect the human subject.
Article 9:In order to protect the interests of human subjects, an independent Ethics Committee shall be formed and such information filed with SFDA. The Ethics Committee shall consist of at least five people of different genders including those working in the medical profession, not working in the medical profession, law experts, and members from other units. The structure and work of the Ethics Committee shall not be influenced by those participating in the trial.
褚世新Article 10: The protocol of the trial must be reviewed and approved by the Ethics Committee. When conducting a clinical trial, any amendment of the protocol may not be implemented without approval from the Ethics Committee. Any serious adverse events that occur during the trial shall be reported to the Ethics Committee..
Article 11:The decisions regarding review and approval of the protocol by the Ethics Committee shall be decided through discussion and voting. Ethnics Committee members shall avoid participating in the clinical trial. Experts who are not members of the committee may be invited to attend the meeting when necessary, but may not vote. The Ethics Committee shall establish its working procedures. Written records for all meetings and the resolutions adopted during meetings shall be kept for five years after the completion of a clinical trial.
Article 12: The Ethics Committee shall strictly examine the following aspects of the protocol in order to protect the interests of human subjects:
1.the qualifications and experience of investigators and whether they will have enough time
to participate in the clinical trial, and whether the staff and equipment conform with the requirements of the trial;
2.whether the ethical principles are fully considered in the protocol, including the purpose
of the investigation, the anticipated risks and benefits to the human subject and other people, and whether the trial is scientifically designed;
3.whether the method of human subject admission and the information about the trial
provided to the human subject, or their families or legal guardians or legal representatives, is complete and easy to understand, and whether the method used to obtain informed consent form is proper;
4.the treatment or insurance provided to a human subject who is harmed or even dies due to
his participation in the clinical trial.
5.whether the recommendations to modify the protocol are acceptable; and,
6.periodic examination of the degree of risks to human subjects participating in the clinical
trial.
Article 13: After receiving the application, the Ethics Committee shall hold a meeting as soon as possible to review and discuss it. The recommendation shall be issued in writing, including listing the attendance of committee members, their specialties and their signatures. The recommendation may:
1.approve;
2.approve after necessary modifications;
3.disapprove;
Article 14: The investigator or its designated representative must explain to the human subject the following clinical trial matters in detail:
1.Participation by the human subject is voluntary. The human subject has the right to
withdraw from the trial at any time during any phase and shall not be subject to discrimination or retaliation. The human subject’s medical treatment and interests shall not be affected.
2.The human subject shall be informed that his participation and personal trial data are
confidential. The Ethics Committee, drug administration authorities and the sponsor, when necessary, may check the human subject’s data according to regulations.
3.The human subject shall be informed of the purpose of the trial, the procedures and
duration of the trial, examination and operational procedures, the predicted possible benefits and risks that the human subject may suffer, and different groups in the trial in which the human subject may be placed.
4.Enough time must be given to the human subject to consider whether to participate in the
trial or not. For a human subject who is unable to express his approval, his legal representative shall be informed of the above introduction and explanations. The explanation regarding the process of obtaining informed consent shall be made to the human subject or his legal representative orally or, in a written language he can understand. During the trial, a human subject has the right to know the trial information concerning himself at any time.
5.If any harm results because of the trial, the human subject may receive medical treatment
and appropriate insurance compensation.
Article 15: The signature on the informed consent form shall be obtained only after the clinical trial has been explained in detail.
1.The human subject or his legal representative as well as the investigator responsible for
the informed consent process shall sign and date the informed consent form.
2. A human subject who is incompetent may participate in a trial on the condition that the
Ethics Committee approves such participation in principle and the investigator considers that the trial will be beneficial for the human subject. The informed consent form must be signed and dated by the legal guardian of the human subject.
3.If the human subject is a child, the informed consent form must be signed by the legal第七次全国人口普查
结果公布 guardian of the child. If the child can decide whether he is willing to participate, the informed consent form shall also be approved by the child.
4.If in emergency, the informed consent form has not been obtained from the human subject
or legal representative, if an effective treatment is lacking but the investigational product could save life, recover health, or alleviate pain, the clinical trial may be conducted.
However, the method used on the human subject shall be explained clearly in the protocol of the trial as well as the relevant file, and approved by the Ethics Committee in advance.
5.If new information regarding the drug used in the trial is discovered, a written amendment
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of the informed consent form must be submitted to the Ethics Committee for approval, afterwhich the human subject agreement must be obtained.
Chapter 4: Protocol for a Clinical Trial
Article 16: The protocol for a clinical trial shall be formulated before starting a clinical trial. The protocol shall be jointly discussed and signed by the investigator and sponsor, then submitted to the Ethics Committee for approval before implementation.
Article 17: The protocol for a clinical trial shall contain the following:
1.The topic of the clinical trial.
2.The purpose(s) and objective(s) of the trial, the background for the trial, findings
regarding the investigational product before the clinical trial that are of clinical significance; results of other clinical trials related to the proposed trial, the possible risks and benefits for human subjects known to date, and the possible ethnic difference of the investigational product.
3.Name and address of the sponsor; the place where the clinical trial will be conducted;
name, qualification and address of the investigator.
4.The type of the design of the clinical trial, the random selection method, and the level of
the blinding.
5.The inclusion criteria, exclusion and removal of human subjects, the procedures for
human subject inclusion, the method of grouping human subject.
6.The number of cases needed statistically to accomplish the purposes of the trial.
7.Form, dosage, route of administration, method and frequency of administration, period of
treatment, order of usage of concomitant medicines, and explanation for package and label.
8.Clinical and laboratory check to be conducted, testing frequency and analysis of
pharmacokinetics.
9.The registration, usage record, delivery and handing and storage conditions of the
investigational products.
10.Clinical observation, on-site visit and measures to ensure the human subject’s compliance
of trial procedures.
11.Rules regarding termination of the clinical trial and rules for the completion of the clinical
trial.
12.The standards for evaluating therapeutic efficacy, including the method for evaluating
parameters, time of observation, recording and analysis.
13.Procedures to maintain the coding of human subject, table of random numbers and case
report form.
14.Requirements for the recording of adverse events and methods for serious adverse event
reporting; measures to handle, methods and time for monitor and outcome.
15.Establishment and maintenance of trial codes, methods to break the blind and rules
concerning how codes may be accessed in emergency situations.
16.The plan of the statistical analysis, the definition and selection for the data package of the
statistical analysis.
17.Rules for data administration and data traced to the source.
18.Quality control and quality assurance of clinical trial.
19.Ethics related to trial.
20.Tentative schedule and completion date of clinical trial.
21.On-site visit and medical treatment after the clinical trial is completed.
22.Each party’s responsibility and other relevant stipulations.
23.Literature.
Article 18: During the trial, the protocol may be modified according to its procedures, if it is really necessary.
Chapter 5: The Investigator’s Responsibilities
Article 19: The investigator responsible for the clinical trial shall:
1.be qualified in a specialized technical position and as a doctor in a medical institution;
2.have the relevant specialized knowledge and experience required in the protocol;
3.have experience in clinical trial research methods or be able to obtain professional
assistance from experienced investigator(s) in his institution;
4.be familiar with the relevant information and literature provided by the sponsor of the
clinical trial;
5.have authorization to allocate the needed staff and facilities for the clinical trial.
Article 20:The investigator shall read and understand the details of the protocol, and conduct the trial strictly according to the protocol.apec
Article 21: The investigator shall understand and be familiar with the properties, functions, effects and safety of the drug to be used (including pre-clinical study documents). He shall know well all new information about the product which information is discovered during the clinical trial.
会计研究Article 22: The investigator shall conduct the clinical trial in a medical institution with good medical treatment facilities, laboratory equipment and personnel. The institution shall have all necessary facilities to handle emergency situations to ensure the safety of human subjects. The result of laboratory evaluations must be correct and reliable. Article 23: The investigator must obtain approval from his hospital or governing unit to ensure that he has enough time to undertake and complete the clinical trial within the period stipulated in the pro
tocol. The investigator shall explain the information, regulations and responsibility about the trial to all personnel participating in the clinical trial, and ensure a sufficient number of qualified human subjects in the clinical trial.
Article 24: The investigator shall explain in detail to the human subjects about the trial as approved by the Ethics Committee and obtain the informed consent.
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Article 25: The investigator is responsible for making medical treatment decisions about the clinical trial, and shall ensure that the human subjects receive proper treatment when adverse event occurs during the trial. Article 26:The investigator has an obligation to adopt and make a record of necessary measures to protect the safety of the human subjects. If a serious adverse event occurs during a clinical trial, the investigator shall immediately provide appropriate medical treatment to the human subject and report to drug administration authorities, the sponsor and the Ethics Committee.. The investigator shall sign and date this report.
Article 27: The investigator shall ensure that the data is duly written down on the case report form in a correct, complete and legal manner.
Article 28: The investigator shall receive monitors and auditors sent by the sponsor for such purposes and auditing and inspection by drug administration authorities in order to ensure the quality of the clinical trial.
Article 29: The investigator and sponsors shall negotiate and provide for the expenses of the
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