DOXPUB 18-0024-SOP

Summary:

Describes a procedure for handling physician requests for use of ¿unapproved¿ systems in the case of a compassionate plea. Applies to requests from US-based physicians only. Covers evaluation criteria, documenting approval, cross-reference letters, obtaining FDA approval, and providing follow-up information. Includes provisions for compliance with applicable FDA regulations.

Included Sections:

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

Included Attachments/Appendices:

Compassionate Plea Check List and Information, Directions for Requesting A Single Use Investigation Device Exemption (IDE)

About This Document:

This is not a generic template, it's a 5-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