DOXPUB 18-0020-SOP

Summary:

Describes the structure and contents of the Central Medical File (CMF), and procedures for ordering new file folders. Also includes the procedures by which original clinical documentation is transmitted, processed, filed and secured. 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:

Project File Structure, Protocol File Structure, Site File Structure, Investigator IDE File Structure, Subject Files Structure, Protocol Files Worksheet, Project File Worksheet, Site File Worksheet, Investigator IDE File Worksheet, and Subject File Worksheet

About This Document:

This is not a generic template, it's a 17-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 project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Clinical Research Associates
• Clinical Study Managers
• Document Control Personnel