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September 2009

Changing Trends: Clinical Research Personnel Qualifications

In the last decade, clinical researchers have conducted clinical trials where their lack of knowledge of human subject protections embodied in Good Clinical Practices and ethical conduct for research (Belmont Report, Declaration of Helsinki) has resulted in clinical trial misconduct and subject deaths. Notably, these cases were reported in both our news media and professional publications.

These cases, Jesse Gelsinger (1999, University of Pennsylvania, Gene Therapy Program) and Ellen Roche (2001, Johns Hopkins Hospital), were inspected by both the FDA and the Office of Human Research Protections (OHRP) with the identification of a broken system of clinical research oversight and human subject protection. These findings document that our 'System of Shared Responsibilities' was gravely broken at these institutions. Granted, since these occurrences, these issues have been addressed by both institutions; however, the 'broken systems' could have been prevented with proper training on human subject protections, GCP training and additional topics.

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Investigator Final Reports: A Tool for FDA Inspection Readiness

During Carl Anderson's career as a FDA field investigator, he met many clinical investigators who were wholly unprepared for the FDA investigation. They couldn't remember anything about the audited study!

What is the best way to prepare for a FDA inspection? Anderson describes ways to make a good first impression on a field investigator using tools available from the FDA.

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BARQA Annual Conference 2009
October 28-30, 2009, Brighton, UK

GMP & FDA Compliant Quality & Doc Systems 2009
November 19-20, 2009, Munich, Germany

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April 20-22, 2010, New York, NY

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Did you know that a document management system can speed your product's time to market? Many pharmaceutical companies are realizing the benefits of DMS technology as it reduces a product's time to market by streamlining pre-clinical, clinical, commercialization and post-market phase documentation and by simultaneously reducing the cost associated with document administration and compliance.
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