What are the management and guidelines for clinical trial organizations?

Drug Clinical Trial Management Regulations Chapter I General Provisions Article 1 In order to strengthen the standardized management of drug clinical trials in our hospital, improve the quality of drug clinical trials and research level, to ensure that the results are scientific and reliable, and to fully protect the rights and interests of the subjects and their safety, in accordance with the State Food and Drug Administration, "Drug Registration Regulations", "Drug Clinical Trial Quality Management Code" and "Drug Research Supervision and Administration Measures" (Trial) relevant requirements, combined with the actual situation of the hospital to formulate these provisions. (for trial implementation)", combined with the actual situation of the hospital, the formulation of these provisions. Article 2 These regulations shall apply to clinical pharmacology organizations, drug clinical trial-related professional departments, laboratories and auxiliary departments of the hospital. Article 3 The drug clinical trials referred to in these provisions include drug clinical Ⅰ, Ⅱ, Ⅲ, Ⅳ and bioequivalence clinical trial research. Chapter II Division of Responsibilities Article 4 The hospital clinical pharmacology institution (hereinafter referred to as the institution) under the leadership of the Department of Medical Education, is responsible for undertaking drug clinical trials, organizing and guiding the implementation of clinical trial projects in relevant professional departments, reviewing, supervising and managing drug clinical trial projects, and validating drug clinical trial summary reports. Article 5 The Medical Ethics Committee of the hospital shall be responsible for the ethical examination, evaluation, supervision and handling of serious adverse events in drug clinical trials. Article 6 Each professional section of drug clinical trial is specifically responsible for the design, implementation, management and summarization of drug clinical trial in its specialty, and accepts the supervision and inspection of the institution and the relevant departments and units at the higher level. Article 7 The expert committee of the institution is responsible for reviewing, guiding and evaluating the specific test plan of some drug clinical trials with wide coverage and high complexity. Chapter III Trial Process Article 8 The drug clinical trial project shall be undertaken by the office of the institution and strictly examined formally, and after passing the formal examination, it shall be submitted to the director of the institution for approval and registration for the record. Article IX acceptance of the trial project, the institutional office and the relevant clinical department coordination, *** with the determination of the undertaking specialty, type of undertaking (responsible for or collaboration) and its project leader and contact person. Article 10 The trial undertaking specialty section shall actively participate in the development and/or discussion of clinical trial documents. (A) As the unit responsible for the project research, the department of the trial undertaking specialty shall designate personnel (researchers with the title of associate senior or above) to assist the sponsor in formulating clinical trial protocols, informed consent and other clinical trial documents, and convene with the sponsor to convene the institution and the clinical trial collaborators to hold a coordination meeting for the implementation of the project, and to discuss and adopt the clinical trial documents. (ii) As the project research collaborating units, the trial undertaking professional sections and institutions shall send representatives to participate in the project implementation coordination meeting organized by the unit in charge of the research and take part in the discussion. Article 11 All drug clinical trial projects must be approved and passed by the Medical Ethics Committee of the hospital before implementation. (I) As the unit in charge of the project research, the clinical trial documents shall be submitted by the sponsor directly to the Medical Ethics Committee of the hospital for approval after they are discussed and approved in the Project Implementation Coordination Meeting. (b) As a collaborating unit of the project, after the clinical trial documents are discussed and approved in the project implementation coordination meeting and approved by the Ethics Committee of the unit in charge of the research, the sponsor shall submit them to the Medical Ethics Committee of the hospital for approval again. Article 12 Before the implementation of the clinical trial, the director of the institution and the person in charge of the trial undertaking specialty shall **** sign a project implementation contract with the sponsor. The contract shall come into effect after being signed by both parties and stamped with the special seal of the pharmacological organization, and shall be kept by the office of the institution. Article XIII of the clinical trial implementation process, the professional departments should be strictly in accordance with the test program and the requirements of the standard operating procedures to carry out the test, the test records should be true, timely, accurate, complete, standardized, shall not be altered, falsified data. Article 14 The experimental drugs shall be received by the specialized personnel of the organization and then issued to the experimental professional departments in a timely manner, and no department or individual shall receive the drugs privately. The test drugs in the department shall be managed by special person, special cabinet and special account to ensure that they are well stored, correctly issued and clearly accounted for. The test drugs shall not be sold or disguised as sold to the subjects or non-clinical trial patients, but shall be customized through the doctor's workstation doctor's orders (inpatient) or prescriptions (outpatient) reflecting the use of medication, and the remaining drugs for the trial shall be returned to the applicant in time through the institution. Article 15 The trial-related examination and test of outpatient subjects shall be conducted free of charge with the electronic application issued by the investigator and the Drug Clinical Trial Examination Voucher (Outpatient) stamped with the special seal of the pharmacological institution, and the trial-related examination and test of inpatient subjects shall be conducted in accordance with the process of the general patients, and the Drug Clinical Trial Examination Voucher (Inpatient) signed by the head (deputy) director of department and stamped with the special seal of pharmacological institution shall be used to reduce or waive the fee and the financial charge sheet at the time of discharge from the hospital. and the financial charge sheet to reduce or eliminate the charge to ensure that the subject is free of charge for the relevant examination and test. Article 16 If a serious adverse event occurs in the subjects during the trial, the researcher, in addition to taking necessary measures, shall immediately report to the project leader and the institution, which shall report to the Medical Ethics Committee of the hospital, the unit in charge of the research, the sponsor and the Food and Drug Administration in accordance with the regulations. Article 17 During the implementation of the trial, the person in charge of the trial project shall keep abreast of the progress and progress of the clinical trial (including contacting the collaborating units), review the trial records in a timely manner, provide guidance to solve various problems occurring in the trial and consciously accept the sponsor's supervision and inspection. Article 18 After the end of the trial, the person in charge of the trial project shall comprehensively review the case report form and the original records, and submit a copy of the case report form to the sponsor or the statistician for data entry after checking for accuracy. Article 19 After receiving the results of statistical analysis of the trial, the person in charge of the trial project shall write a summary report of the trial in accordance with the specification requirements and submit all the trial information and original records to the institutional office. Article 20 After the summary report is reviewed and approved by the institutional office, it shall be submitted to the director of the institution for final examination and signature and stamped with the special seal of the pharmacological institution, and then handed over to the sponsor, the professional section of the trial and the institutional office for retention respectively. Article 21 If the clinical trial is discontinued for various reasons, it shall be reported to the office of the pharmacological organization in a timely manner and consent shall be obtained, and if necessary, it shall be reported to the Medical Ethics Committee of the institution for approval and consent at the same time, and the relevant procedures shall be improved in accordance with the requirements for the discontinuation of the clinical trial project. Chapter IV Funding Management Article 22 When signing a contract for the implementation of the trial project, the clinical research funding provided by the sponsor must be specified in the contract. Article 23 The clinical research funds provided by the sponsor shall be remitted to the designated account of the hospital according to the agreement in the contract, and shall be managed in a special account. Article 24 15% of the clinical research funds shall be set aside as the hospital management fee, 10% shall be set aside as the organization management and operation cost, 5% shall be the organization staff labor cost, and 70% shall be the departmental trial observation fee (including relevant examination fee, subject compensation fee and staff labor cost). Article 25 The hospital management fee and institutional management and operation fee shall be separately capitalized by the institution's finance, and the funds shall be exclusively used for the purpose. Institutional management and operation costs shall be managed by the institution, and any costs related to the construction of pharmacological institutions, test management or coordination costs can be expended after the approval of the leadership of the Department of Medical Education. Article 26 The labor cost of the staff of the institution and the test observation fee of the department shall be applied by the institution uniformly after the arrival of the funds, and shall be withdrawn in cash through the finance of the institution according to the approval procedure and authority of the hospital and the approval of the Medical Education Department and the leadership of the hospital. The departmental test and observation fee shall be distributed directly by the institution to the relevant departments according to the distribution ratio determined in consultation with the relevant departments at the time of signing the project contract. Chapter V Supervision and Inspection Article 27 The person in charge of each drug clinical trial specialty shall inspect the progress and quality of the drug trial in the specialty from time to time, review the situation of the trial records, and correct the problems in time. Article 28 The sponsor sends supervisors to the trial department from time to time in accordance with the needs of the trial to carry out supervision and inspection, the relevant departments shall actively assist and cooperate, and make timely improvements according to the views of the supervisors. Article 29 The office of the organization shall send internal supervisors to regularly supervise the quality of the tests of the research and completed projects of each specialized department, and report the results of the inspections to the Medical Section of the Ministry of Medical Education after regular statistics are summarized. Article 30 The Department of Medical Education organizes experts to inspect the experiments of the institution and various professional departments from time to time. Article 31 The Medical Ethics Committee of the institution conducts inspections on ethical issues in clinical trial programs from time to time. Chapter VI Rewards and Punishments Article 32 No department or individual shall accept the task of drug clinical trial on their own, or bear all the adverse consequences caused by it, and the hospital will recover the illegal income of the responsible department, notify and criticize and impose a fine of more than three times of the illegal income according to the seriousness of the situation. Article 33 The falsification of medical records, inspection and test reports or case report forms and other trial records, found one / times to give a warning, and deduct the responsible department quality control points 10 points, deducted 10% of the department's test observation fee; found two / times suspended the department's acceptance of clinical trials for one year, and deducted 20 points of quality control points, deducted 50% of the department's project test observation fee; the circumstances are serious or lead to serious consequences doubled the penalty. The circumstances are serious or lead to serious consequences, and the punishment shall be doubled. Article 34 For the general unqualified items that violate the standard operating procedures of clinical trials, 2 quality control points shall be deducted from the quality control points of the responsible department for each discovery. Article 35 During the trial period, if the researchers charge the subjects for medicines, examination fees or sales of experimental medicines privately, 10 quality control points shall be deducted from the quality control points of the responsible department upon discovery, and the offending proceeds shall be confiscated and a fine of three times shall be imposed. Article 36 The researchers abuse the free inspection and test, provide free inspection and test to non-subjects, once found deduct 10 points of quality control points of the responsible department and impose a fine of 3 times of the amount of the illegal inspection items. Chapter VII Supplementary Provisions Article 37 The clinical research of new pharmaceutical products (including new instruments, devices, materials, etc.), reevaluation of approved new drugs, health products, etc. shall, in principle, refer to these provisions. Article 38 The specific operational technical requirements of each link of the drug clinical trial shall be implemented according to the standard operating procedures (SOP) issued by the institutional office. Article 39 These provisions shall be implemented from the date of issuance. The drug clinical trial program that has been carried out before the issuance of these provisions shall still be implemented in accordance with the original provisions. Article 40 The interpretation of these regulations shall be vested in the Ministry of Medical Education. Where there is any conflict between the previous documents and these regulations, these documents shall prevail.