FDA CVM GFI #85 (VICH GL9) Good Clinical Practice
标准简介
CVM GFI #85 (VICH GL9) Good Clinical Practice[附网盘链接]是FDA于过去发布的FDA标准，适用于US。标准截图
![CVM GFI #85 (VICH GL9) Good Clinical Practice[附网盘链接]](/img/20210914103707xiwtp.jpg)
标准文档说明
标准文档类型为CVM GFI #85 (VICH GL9) Good Clinical Practice[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
GOOD CLINICAL PRACTICE This guidance represents 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 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 of veterinary products in the target species. 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 those 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 imposed 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. Page 5
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