DOXPUB 18-0022-SOP

Summary:

Describes the procedure for recording, evaluating and reporting adverse events (AE) occurring during a company sponsored clinical investigation within Europe. Covers AE reporting to sponsors, AE evaluation, reporting to investigators and Competent Authorities, handling AEs after study closure, and filing. Includes provisions for compliance with EN-540 (Clinical investigation of medical devices for human subjects), and MDD 93/42/EEC: Annex X.

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 3-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