standard published 08/01/2007 by Doxpub, Inc.
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 projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:
Clinical Research AssociatesClinical Study ManagersRegulatory Affairs Personnel
