DOXPUB 18-0025-SOP


Audits of Clinical Research Edition: 1.0
Doxpub, Inc. / 01-Aug-2007 / 3 pages

Summary:Describes a procedure for verifying that the documents and records for a given clinical study conform with clinical guidelines and FDA requirements. Intended for trials conducted in the US only. Covers criteria for performing selective audits, as well as internal and external audits requirements.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:NoneAbout 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 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

Keywords: Clinical Research

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