DOXPUB 18-0021-SOP

Summary:

Describes a process for assuring that company sponsored clinical trials in Europe have the appropriate regulatory approvals before the start of the trial and before a protocol amendment is implemented. Covers document assembly, notification of Competent Authority and documentation activities. Includes provisions for compliance with EN-540 (Clinical investigation of medical devices for human subjects), and MDD 93/42/EEC: Annex VII and X.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Clinical Trial Checklist

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