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DOXPUB 18-0005-SOP

$9.50

Identification and Qualification of Clinical Laboratories Used for Clinical Studies
standard by Doxpub, Inc., 08/01/2007

Category:

Description

Summary:

Describes the process for Clinical Research Associates (CRA) or other individuals to confirm the qualifications of a laboratory prior to initiating a clinical study that requires laboratory testing. Covers US- and European-based clinical research activities. 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:

None

About This Document:

This is not a generic template, it's a 2-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:
2
File Size:
1 file , 270 KB