Full Description

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 Procedures

Included Attachments/Appendices:

None

About 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 doing

Who Will Benefit:

Clinical Research AssociatesClinical Study ManagersRegulatory Affairs Personnel

Product Details:

Edition: 1.0 Published: 08/01/2007 Number of Pages: 2