概述:描述临床研究助理（CRA）或其他个人在启动需要实验室测试的临床研究之前确认实验室资质的过程。涵盖美国和欧洲的临床研究活动。包括符合EN-540（人体受试者医疗器械临床研究）、MDD 93/42/EEC:附件VII和X以及适用的FDA法规和指南的规定。包括的章节:目的、范围、责任、参考文献和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括的附件/附录:无关于本文件:这不是一个通用模板，它是一个两页的程序，实际上是在FDA的临床研究操作中创建和使用的- 受监管的机构。公司特定信息（名称、地址、一些图片、专有产品信息等）已被编辑，但内容和格式已基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司在做什么，谁将从中受益:临床研究协会临床研究经理监管事务人员

Summary:Describes the process for Clinical Research Associates (CRA) or other individuals to confirm the qualifications of a laboratory prior to initiating a clinical study that requires laboratory testing. Covers US- and European-based clinical research activities. Includes provisions for compliance with EN-540 (Clinical investigation of medical devices for human subjects), MDD 93/42/EEC: Annex VII and X, and applicable FDA regulations and guidances.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:NoneAbout This Document:This is not a generic template, it's a 2-page procedure that was actually created and used in the Clinical Research operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Clinical Research AssociatesClinical Study ManagersRegulatory Affairs Personnel