兽药临床试验管理规范GOOD CLINICAL PRACTICE
VICH GL9
Translated by Chen Jianzhao
2017.08
Guangzhou General Pharmaceutical Rearch Institute (GPRI)
Guidance for Industry
GOOD CLINICAL PRACTICE
VICH GL9
FINAL GUIDANCE
(This document was revid 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 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 nt to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on the Internet at v. All written comments should be identified with Docket No 99D-2406.
For questions regarding this guidance document, contact Herman M. Schoenemann (HFV-100), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8302, e-mail: herman.schoenemann@v.
U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine
May 9, 2001
Final Guidance
INTRODUCTION
1. GLOSSARY
1.1. Adver Event (AE)
1.2. Applicable Regulatory Requirement(s)
1.3. Audit
1.4. Authenticated Copy 行业指南
兽药临床试验管理规范
VICH GL9
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（HFA-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：//v。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.schoenemann@v
美国卫生与人类服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 (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
1.5. Blinding (Masking)
1.6. Ca Report Forms/Data Capture Forms/Record Sheets 1.7. Clinical Study
1.8. Compliance (in relation to studies)
1.9. Control Product
1.10. Contract Rearch Organization (CRO)
1.11. Disposal of Investigational Veterinary Products
1.1
2. Disposal of Study Animals
1.13. Final Study Report (FSR)
1.14. Good Clinical Practice (GCP)
1.15. Informed Connt
1.16. Inspection
1.17. Investigational Veterinary Product
1.18. Investigator
1.19. Monitor
1.20. Multicenter Study
1.21. Quality Assurance (QA)
1.2
2. 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 Protocol Amendment
1.31. Study Protocol Deviation
1.3
2. Target Animal
1.33. Veterinary Product
2. THE PRINCIPLES OF VICH GCP
3. THE INVESTIGATOR
3.1. General 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）
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 (10)
3研究者 (11)
3.1概要
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 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 reprents FDA’s 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 ud 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 of veterinary products in the target species. 4. 申办者 (15)
4.1概要..
4.2职责..
4.3委托CRO
5监察员 (18)
5.1概要..
5.2职责
6.研究方案 (20)
6.1概要
6.2研究方案审查
6.3研究方案检查表
7.最终研究报告 (25)
7.1概要
7.2作者
7.3最终研究报告内容
7.4报告修改
8.研究文件 (28)
8.1概要
8.2研究文件类别
8.3记录和处理研究文件
8.4保留研究文件
良好的临床实践
本指南代表FDA目前在此事项上的想法，不会为任何人创造或赋予任何权利，也不会对FDA或公众产生约束力。只要符合适用的法规和规定的要求，可以使用另一种方法。
前言
本文件的目的是为所有目标品种受试兽药的临床研究设计和实施提供指导。
It is directed at all individuals and organizations involved in the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies in target species and is intended to ensure that such studies are conducted and documented in accordance with the principles of Good Clinical Practice (GCP).
Good Clinical Practice is intended to be an international scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting clinical studies evaluating veterinary products. Compliance with this standard provides public assurance about the integrity of the clinical study data, and that due regard has been given to animal welfare and protection of the personnel involved in the study, the environment and the human and animal food chains.
This guidance has been developed under the principles of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and will provide a unified standard for the European Union (EU), Japan and the United States of America (USA) to facilitate the mutual acceptance of clinical data by the relevant regulatory authorities. This guidance was developed with consideration of the current practices in the EU, Japan and the USA together with tho of Australia and New Zealand.
This guidance should be followed when developing clinical study data that are intended to be submitted to regulatory authorities.
When a guidance document states a requirement impod by law, the requirement is law and its force and effect are not changed in any way by virtue of its inclusion in the guidance document.
1. GLOSSARY
1.1. Adver Event (AE)
Any obrvation in animals that is unfavorable and unintended and occurs after the u of a veterinary product or investigational veterinary product, whether or not considered to be product related.
1.2. Applicable Regulatory Requirement(s)
Any law(s) and regulation(s) of the relevant regulatory authority addressing the conduct of studies using investigational veterinary products. 它针对参与目标物种临床研究的设计，实施，监测，记录，审核，分析和报告的所有个人和组织，旨在确保这些研究按照“药物临床试验质量管理规范”（GCP）的原则实施和记录。
药物临床试验质量管理规范旨在成为评估受试兽药的临床研究的设计，实施，监测，记录，审核，分析和报告的国际科学质量标准。遵守这一标准提供了公众对临床研究数据的完整性的保证，并且适当考虑了动物福利和保护参与研究的环境、人员和动物食物链。
本指引是根据国际合作兽医药品注册技术要求协调原则（VICH）制定的，将为欧盟（EU），日本和
美国（美国）提供统一的标准。促进相关监管机构相互接受临床资料。本指导意见是针对欧盟，日本和美国以及澳大利亚和新西兰的现行做法制定的。
制定旨在提交给监管机构的临床研究数据时，应遵循本指导原则。
当指导性文件声明为法律强制要求时，该要求就是法律，其作用和效力不会因为纳入指导性文件而改变。
1 术语
1.1不良反应（AE）
在使用了兽药或受试兽药后在动物身上观察到的不利的或非预期的结果，不管这种结果是否与药品有关。
1.2适用的监管要求
涉及使用受试兽药进行研究的有关监管机构的任何法律和法规。
