Description
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
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 3
- File Size:
- 1 file , 290 KB
