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1、Good Clinical Practice VICH GL9 (FDA Version, Translated by Chen JZ, GPRI, 2017.08) 兽药临床试验管理规范兽药临床试验管理规范 GOOD CLINICAL PRACTICE VICH GL9 Translated by Chen Jianzhao 2017.08 Guangzhou General Pharmaceutical Research Institute (GPRI) 1 Good Clinical Practice VICH GL9 (FDA Version, Translated by Chen J
2、Z, GPRI, 2017.08) Guidance for Industry GOOD CLINICAL PRACTICE VICH GL9 FINAL GUIDANCE (This document was revised on June 8, 2011 to update the contact information, add the Table of Contents, update hyperlinks, and minor formatting changes) This final guidance is intended to provide guidance on the
3、design and conduct of all clinical studies of veterinary medicinal products in the target species submitted for approval to the European Union, Japan, and the United States. Comments and suggestions regarding this guidance should be sent to the Division of Dockets Management (HFA-305), Food and Drug
4、 Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on the Internet at http:/www.regulations.gov. All written comments should be identified with Docket No 99D-2406. For questions regarding this guidance document, contact Herman M. Schoene
5、mann (HFV-100), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8302, e-mail: herman.schoenemannfda.hhs.gov. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine May 9, 2001 Final Guidan
6、ce INTRODUCTION 1. GLOSSARY 1.1. Adverse Event (AE) 1.2. Applicable Regulatory Requirement(s) 1.3. Audit 1.4. Authenticated Copy 行业指南行业指南 兽药临床试验管理规范兽药临床试验管理规范 VICH GL9 最终指导最终指导 （本文件于 2011 年 6 月 8 日修订，更新联系信息，添加目录，更新超链接和次 要格式更改） 本指南旨在为提交给欧盟，日本和美国的目标物种的兽药产品的所有临床研究 的设计和实施提供指导。 有关本指南的意见和建议应发送给食品和药物管理局（HF
7、A-305） ，食品和药物 管理局，5630 Fishers Lane，1061 室，Rockville，MD 20852.评论也可以在互联网 上以电子方式提交：http： /www.regulations.gov。所有书面意见应使用 Docket No 99D-2406 进行识别。 有关本指南文件的问题，请联系 Herman M. Schoenemann（HFV-100） ，食品和药 物管理局兽医医学中心，7500 Standish Pl.，Rockville，MD 20855,240-276-8302， 电子邮件：herman.schoenemannfda.hhs.gov 美国卫生与人类服
8、务部食品和药物管理局 兽医中心 二一年五月九日 最终指导. 2 前言. 4 1 术语术语. 5 1.1 不良反应（AE） 1.2 适用的监管要求 1.3 审核 1.4 已验证副本 2 Good Clinical Practice VICH GL9 (FDA Version, Translated by Chen JZ, GPRI, 2017.08) 1.5. Blinding (Masking) 1.6. Case Report Forms/Data Capture Forms/Record Sheets 1.7. Clinical Study 1.8. Compliance (in rela
9、tion to studies) 1.9. Control Product 1.10. Contract Research Organization (CRO) 1.11. Disposal of Investigational Veterinary Products 1.12. Disposal of Study Animals 1.13. Final Study Report (FSR) 1.14. Good Clinical Practice (GCP) 1.15. Informed Consent 1.16. Inspection 1.17. Investigational Veter
10、inary Product 1.18. Investigator 1.19. Monitor 1.20. Multicenter Study 1.21. Quality Assurance (QA) 1.22. Quality Control (QC) 1.23. Randomization 1.24. Raw Data 1.25. Regulatory Authorities 1.26. Sponsor 1.27. Standard Operating Procedure (SOP) 1.28. Study Animal 1.29. Study Protocol 1.30. Study Pr
11、otocol Amendment 1.31. Study Protocol Deviation 1.32. Target Animal 1.33. Veterinary Product 2. THE PRINCIPLES OF VICH GCP 3. THE INVESTIGATOR 3.1. General 3.2. Responsibilities 1.5 盲法（掩蔽） 1.6 病例报告表/数据记录表格/记录表 1.7 临床研究 1.8 依从性（关于研究） 1.9 对照药 1.10 合同研究组织（CRO） 1.11 受试兽药的处置 1.12 受试动物的处置 1.13 最终研究报告（FSR）
12、 1.14 药物临床试验质量管理规范（GCP） 1.15 知情同意书 1.16 稽查 1.17 受试兽药 1.18 研究者 1.19 监察员 1.20 多中心研究 1.21 质量保证（QA） 1.22 质量控制（QC） 1.23 随机 1.24 原始数据 1.25 监管机构 1.26 申办者 1.27 标准操作规程（SOP） 1.28 受试动物 1.29 研究方案 1.30 研究方案修改 1.31 研究方案偏离 1.32 靶动物 1.33 兽药产品. 2 VICH GCP 的原则的原则. 10 3 研究者研究者. 11 3.1 概要 3.2 职责 3 Good Clinical Practic
13、e VICH GL9 (FDA Version, Translated by Chen JZ, GPRI, 2017.08) 4. THE SPONSOR 4.1. General 4.2. Responsibilities 4.3. Delegations to a CRO 5. THE MONITOR 5.1. General 5.2. Responsibilities 6. THE STUDY PROTOCOL 6.1. General 6.2. Study Protocol Review 6.3. Study Protocol Check List 7. THE FINAL STUDY
14、 REPORT 7.1. General 7.2. Authorship 7.3. Content of Final Study Report 7.4. Report Amendments 8. STUDY DOCUMENTATION 8.1. General 8.2. Categories of study documentation 8.3. Recording and handling study documentation 8.4. Retention of study documentation GOOD CLINICAL PRACTICE This guidance represe
15、nts FDAs current thinking on this matter and does not create or confer any rights for or on any person, and does not operate to bind FDA or the public. An alternate method may be used as long as it satisfies the requirements of the applicable statutes and regulations. INTRODUCTION The objective of this document is to provide guidance on the design and conduct of all clinical studies o
