DOXPUB 18-0010-SOP
- Review and Editing of Case Report Forms
- standard by Doxpub, Inc., 08/01/2007
- Publisher: DOXPUB
$10.00$19.00
Summary:
Describes how Case Report Forms (CRFs) are to be reviewed and edited. Covers reviewing and editing of case report forms during site visits and correction of original CRFs brought in-house. 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 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
- Regulatory Affairs Personnel
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