摘要:描述如何以及何时发送纸质病例报告表（CRF）进行数据输入。包括目视检查、放入中央医疗文件、隔离和准备进入临床数据库。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 how and when paper-based Case Report Forms (CRFs) are routed for data entry. Covers visual inspection, placing in Central Medical Files, sequestering, and preparing for entry into a clinical database. 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