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Barnett Releases Reference Guide on Form FDA 1572--Statement of Investigator
Date:10/11/2008

Barnett International, a division of Cambridge Healthtech Institute (CHI), has announced the release of The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors. Designed for clinical investigators, clinical site staff, study monitors, regulatory affairs professionals, and others involved in the clinical research process, the text is the first reference guide to address the Form FDA 1572-Statement of Investigator form, a critical regulatory document that well over 20,000 clinical investigators complete and sign each year before participating in FDA-regulated clinical trials.

Needham, MA (PRWEB) October 11, 2008 -- The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors addresses an emerging reality in clinical research today: As the number of FDA-issued warning letters to clinical investigators has risen in recent years, so too have citations regarding investigators' failure to complete the 1572 appropriately and correctly.

This new, state-of-the-art reference guide was developed to help not only experienced clinical investigators, who continue to struggle with addressing emerging trial-related complexities of modern clinical trials in the 1572, but the growing number of investigators who are conducting their first FDA-regulated trials each year. In addition to the FDA's emerging expectations regarding the 1572, the new reference guide directly addresses new 1572-related challenges facing clinical investigators and industry trial sponsors, including: the implications of what the FDA calls the "dispersing of study functions;" Norway's recent ban against the 1572; the evolution of the "subinvestigator" concept; and the increasing role of non-U.S. clinical investigators in FDA-regulated clinical trials.

The Form FDA 1572 reference guide addresses the most often-asked--but never answered--questions and also e
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