DOXPUB 18-0015-SOP

Summary:

Describes the process for the development, review, and approval of clinical study protocols and protocol amendments. Covers draft preparation, determining regulatory submission requirements, comments and revisions, approval signing, distribution of approved copies, contents of protocols and amendments, and insurance carrier participation. 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:

Protocol/Protocol Amendment Approval Form, Investigator's Agreement, Protocol Amendment Table

About This Document:

This is not a generic template, it's a 7-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