By Hazel Hart,2014-11-15 15:31
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    credible. Ethics Committee and informed consent form are 附录7 major measures to ensure the protection of the rights and Chinese benefits of human subjects. Good Clinical Practice ?9 Ethics Committee should be established within the medical institution where the clinical trial is conducted to Chapter 1 General Provisions ensure the protection of the rights and welfare of human ?1 The China GCP is formulated to ensure the subjects involved in a trial and to provide public reassurance. clinical trial process standardized, the results scientific and An Ethics Committee should consist of at least one law credible, and the rights, benefits and safety of trial subjects specialist, member from other institute, and non-medical protected. It is based on “Drug Administration Regulations person. At least five members of both genders should be in of People's Republic of China” and in accordance with the the Ethics Committee. The composition and operations of international recognized principles. Ethics Committee should be independent and not influenced ?2 The China GCP is a standard regarding the whole by those who are involved in the trials. process of clinical trials including protocol designing, ?10 Prior to a clinical trial, the protocol can not be organizing, conducting, monitoring, auditing, recording, implemented until it has been approved by the Ethics analyzing, and reporting. Committee. During the trial, any subsequent protocol ?3 The clinical trials of all drugs, in various phases, amendment must be approved by the Ethics Committee including human bioavailability or bioequivalance study before its implementation. All serious adverse events must be performed according to the China GCP Guidelines. (SAEs) occurred during the trial must be reported to the Ethics Committee. Chapter 2 Preparations and Prerequisites for a Clinical ?11 The decision from the review process should be Trial put to the vote, the ethics committee members involved in ?4 All research involving human subjects should be the trial should abstain from voting. The committee can conducted in accordance with the ethical principles, invite experts who are not committee members to attend the contained in “Declaration of Helsinki” (see appendix 1), meeting, but non-committee members are not expected to namely justice, respect for persons, beneficence (to vote. The Ethics Committee should have its own working maximize benefits and to minimize harms and wrongs) and procedures. All meetings and resolutions should be non-maleficent (to do no harm), as defined by the current documented and retained for a period of at least 5 years revision of “International Ethical Guidelines for Biomedical after the completion of the trial. Research Involving Human Subjects” issued by the Council ?12 In the light of protecting the rights and benefits of for International Organizations of Medical Sciences the trial subjects, Ethics Committee should review the (CIOMS). All individuals involved in the conduct of any protocol in the following aspects strictly. clinical trial must be fully informed of and comply with 1 The qualifications and experiences of the these principles, and adhere to Chinese laws and regulations investigator; whether the investigator is available to relating to the drug administration. participate in the clinical trial; whether the staff allocation ?5 To initiate a clinical trial, sufficient scientific and facilities are in conformity with the requirements of the rationale should be provided. Prior to planning of a clinical trial. trial in humans, the specific aims, the problems to be 2 Whether the protocol is appropriate, including the solvedanticipated efficacy and possible risks must be aim of the study, potential risks and benefits for the subjects considered thoroughly. Anticipated benefits should prevail and others, and the scientific efficiency of the study design. over possible risks. The chosen clinical trial solutions must 3 The methods for the subjects recruitment; whether conform to the scientific and ethical standard. the information given to the subjects, their relatives, ?6 Investigational product(s) should be prepared and guardians or legal representatives is complete and easy to

    understand; whether the means to obtain the informed provided by the sponsor. Before conducting clinical trials, consent form is appropriate. the sponsor is responsible for providing pre-clinical data of 4 Whether medical treatment and/or insurance are the investigational product, including composition of the available to the subjects in case of trial-related injury or formula, manufacturing process, and quality analysis reports. death. The pharmaceutical, pre-clinical, and existing clinical data 5 Whether revisions and/or amendments to the should meet the requirements for conducting respective protocol are acceptable. phases of the clinical trial. In addition, the information on 6 Regular reviews for the risk and its extent of the safety and efficacy collected in completed and ongoing trial subjects should be done during the clinical study. clinical trials elsewhere with the investigational product

    should be also provided to prove that the investigational ?13 After receiving the application, the Ethics product is appropriate for clinical trials, so as to indicate its Committee should arrange a meeting as early as possible to safety and possible clinical application. review, discuss and endorse its decisions in writing, with the ?7 The facilities and conditions of the study sites name list of the committee members present at the meeting,

    committee members' specialties and signatures. The involved in the clinical trial should comply with the decision of the ethics committee can be expressed in the requirements for conducting the trial safely and efficiently. following terms: Each investigator should have appropriate expertise, (1) approval/favorable opinion; qualifications and competence as well as training in the (2) approval/favorable opinion after necessary revision GCP to undertake a proposed study. Prior to the trial, the required; investigator(s) and the sponsor should reach an agreement (3) disapproval/negative opinion; on the protocol, the monitoring and auditing, standard (4) termination/suspension of approved trials. operating procedures (SOP), and the allocation of trial-

    related responsibilities. ?14 Investigators or their appointed representatives

     should provide trial subjects with detailed information Chapter 3 Protection of Trial Subjects' Rights and Benefits related to the clinical trial.

    ?8 The personal integrity and welfare of the trial 1 The subject should take part in the trial voluntarily

    and is at liberty to withdraw from the trial at any time subjects must be fully protected during the process of the

    clinical trial. The trial must also be ensured scientific and



    without being prejudiced, revenged and his/her medical and results from relevant clinical trials; the known potential treatment, rights and welfare impaired; risks and benefits to human subjects.

    2 The subject must be made aware that the personal 3. Sites of the clinical trial; name and address of the data and materials relating to the trial or regarding sponsor; names, qualifications, and addresses of participation of the trial should be kept confidential. investigators.

    However, the ethics committee, the drug regulatory 4. Design of the trial (control or open, parallel or authorities or the sponsor can have access to the subjects' crossover, double-blind or single-blind, randomization personal data and materials concerning the trial in methods and procedures, single or multiple centers, etc.). accordance with required procedures when needed; 5. Criteria for inclusion and exclusion of trial 3 The aim, process and duration of the trial, tests subjects and process of recruitment, methods of allocation and operation procedures, expected benefits, possible risks of subjects, withdrawal criteria.

    or inconveniences and the probability of allocation to 6. Number of trial subjects needed to achieve the different group of the trial should be explained to the trial objective based on statistical considerations. subjects in detail; 7. Route and frequency of administration, dosage 4 During the trial, the subject can have access to any and duration of treatment, concomitant medication for the information relating to him/her at any time. Enough time investigational product and comparator product being must be given to the subject for consideration of whether formulated in accordance with the results from he/she is willing to participate in the trial. When the subject pharmacodynamic and pharmacokinetic studies and dose-is incapable to give his/her informed consent, his/her legal response relationships.

    representative should be provided with the above 8. Items of clinical and laboratory examinations, information. The spoken and written language used for times of their measurements, and pharmacokinetic analysis, instruction of the informed consent must be easy to etc.

    understand by the subject and his/her legal representative. 9. Receipt registering, use recording, transferring, 5 If trial related damage occurs to the subject, dispensing and storage condition for the investigational he/she can be entitled to medical treatment and/or insurance product(s), including the placebo(s) and active control. compensation. 10. Clinical observation, follow-up procedures and

    measures to ensure patients' compliance with the protocol. ?15 The informed consent form is obtained after a 11. Criteria for suspension and termination of clinical sufficient and comprehensive explanation of the trial. trials, instructions on completing the clinical trial. 1 The informed consent form should be signed and 12. Defined criteria of efficacy assessment, including dated by the subject or subject's legally acceptable methods and timing for assessing, recording and analyzing representative, and by the investigator or appointed efficacy parameters. representative who conducted the process to obtain the 13. Procedures for the maintenance of subject informed consent form. identification code lists, treatment records, randomization 2 When both the subject and his/her legally list and case report form (CRF). acceptable representative are incapable to read, a witness 14. Recording requirements for adverse events and should be present during the entire process of obtaining the reporting methods for serious adverse events, measures for consent. After the subject or his/her legally acceptable management of complications, the way and time of the representative being provided with the detailed explanation follow-up visit. of the informed consent form and gives oral consent, the 15. Establishment and maintenance of trial witness is required to sign and date the consent form. randomization codes, and how and by whom it can be 3 If the subject is incapable to give personal consent broken in the event of an emergency. (e.g. children, those suffering from severe mental illness or 16. Description of methodology on the evaluation of disability), the inclusion of such patients in a trial may be results and rationale to withdraw patient from final report acceptable if the Ethics Committee is, in principle, in when necessary. agreement and if the investigator believes that the subject's 17. Regulations for data management and record participation is in his/her interest, for which the legal archiving. guardian of the subject is required to sign and date the 18. Quality control and quality assurance for clinical informed consent form. trials. 4 If none of the signed informed consent form from 19. Anticipated progress and completion date of the the subject, guardian and witness is obtained, such status clinical trial. and the reasons of failing to obtain the consent form must be 20. Medical care after completion of the clinical trials. documented in detail and signed by the investigator. 21. Statements regarding responsibilities for each 5 If any new important information related to the party and publication policy. investigational product arises, revision to the informed 22. List of references. consent form must be made and sent to the Ethics During clinical trials, if necessary, the protocol can be Committee for approval. It is necessary to regain the amended according to specific regulations. consent form from trial subjects. Chapter 5 Responsibilities of the Investigator Chapter 4 The Protocol ?18 The investigator responsible for the clinical trial ?16 Before the clinical trial is conducted, the protocol should meet the following requirements: should be worked out, agreed upon and signed by both 1. The investigator should be qualified as a medical investigator and sponsor. It can not be implemented until doctor working in a legally approved medical institution. reviewed and approved by Ethics Committee. 2. The investigator should have good knowledge and ?17 The contents of a trial protocol should include the experience of the field of medicine defined by the protocol. following topics: 3. The investigator should be experienced in 1. Title and rationale for the clinical trial. research methods of clinical trial, or be able to get (revive) 2. Purpose and objectives of the trial; background of scientific support from an experienced colleague. the trial, including name of the investigational product;

    findings with clinical significance from non-clinical studies



    4. The investigator should be aware of available ?31 The responsibilities of a sponsor include initiation, relevant data and literature and all information provided by application, organizing, funding and monitoring of a clinical the sponsor. trial. The sponsor is usually a pharmaceutical company, but 5. The investigator should have access to human and may also be an organization or institution. If the sponsor is other resources needed for the conduct of the trial. a foreign company or organization, it is required to have a 6. The investigator should be aware of GCP, and legal person as a registered representative in China to comply with relevant legal, regulatory and ethical perform duties defined by Chinese regulations. The sponsor requirements of the country. should submit application for a clinical trial to the State ?19 The investigator is required to have a thorough Drug Administration in the light of related law, regulations study and understanding of the protocol, sign the protocol and rules in China. The sponsor may transfer some together with the sponsor and carry out the trial in strict activities of a clinical trial to a contract research compliance with the protocol and the GCP guideline. The organization (CRO).

    investigator should submit the protocol timely to the Ethics ?32 The sponsor recommends clinical trial institutions Committee for approval. and investigators, and confirms their qualifications and ?20 The investigator is required to understand the conditions to assure the completion of the clinical trial. nature, actions, efficacy and safety (including pre-clinical ?33 The sponsor is responsible for providing the data) of the investigational product(s). In addition, the Investigator's Brochure, which includes the investigator should be kept informed of any new chemical/pharmaceutical, toxicological, pharmacological, information about the product arising in the process of the and clinical data (including data from previous and ongoing clinical trial. trials) regarding the investigational product(s). ?21 The investigator is required to conduct the clinical ?34 After obtaining approvals from the State Drug trial in the institution with sound medical facilities, Administration and the Ethics Committee, the sponsor starts laboratory equipment and staff. The institution should have to implement the clinical trial in accordance with the all necessary facilities dealing with emergency to ensure protocol and the GCP. safety of trial subjects. The results of laboratory ?35 The sponsor should work together with the examinations should be correct and reliable. investigator to design the protocol, and specify trial related ?22 The investigator should obtain permission from responsibilities for each party, including data processing, the hospital or institution that he/she works for and ensure statistical analysis, preparation of trial report, the way of that he/she has sufficient time to conduct and complete the publication, etc. The agreed protocol and contract should be trial within the schedule defined in the protocol. The signed by both parties. investigator is required to illustrate relevant materials, ?36 The sponsor is responsible for providing the regulations and responsibilities to all of the staff involved in investigators with the easily distinguishable investigational the trial. It is the investigator's responsibility to ensure new drug(s), standards, controls, or placebo with proper sufficient number of subjects who meet the inclusion criteria code and specific labels, and ensuring the quality of the defined in the protocol to enter the trial. products. These products should be packaged appropriately ?23 The investigator should provide and explain the in accordance with the protocol (e.g., blinding, if applicable) detailed information about the trial approved by the Ethics and kept with batch/serial numbers. The sponsor should Committee to the subjects, and obtain informed consent establish management and recording systems for registering, forms from the subjects. maintaining and distribution of the products. ?24 The investigator is responsible for medical ?37 The sponsor should appoint monitors acceptable decision making in relation to the trial, to ensure adequate to the investigator for monitoring the carrying out of the medical treatment to be provided to the subject whenever clinical trial. any adverse event occurs. ?38 The sponsor is responsible for establishing the ?25 The investigator is obliged to take necessary quality control and quality assurance systems for clinical measures to ensure the safety of subjects, and such measures trials. If necessary, the sponsor can organize auditing for should be documented. In case of SAEs, the investigator the clinical trial to ensure the quality of the trial. must take appropriate measures to protect subjects, and ?39 The sponsor must discuss together with the report to the drug regulatory authorities, the sponsor and the investigator(s) as soon as serious adverse event occurs, take Ethics Committee immediately, and sign and date the