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Taken from the NEW Good Clinical Practice: A Question & Answer Guide 2015.

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Question: If an FDA inspector and the agency’s district office determine that an investigator committed fraud and/or endangered the safety of his or her subjects, will the FDA report these findings to the investigator’s state licensing board? What about cases in which subjects were in “imminent danger,” say from reckless prescribing/dosing?

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Barnett International Announces New SOP Development and Optimization Courses
February 21, 2012
Barnett International Announces New Fall-Winter Courses 2012
February 20, 2012
Barnett Educational Services Announces Buy One, Get One Free DVD Holiday Sale!
December 15, 2011
Hamrell Appointed Editor of Barnett International’s Good Clinical Practice: A Question & Answer Guide
November 16, 2011
Barnett International Announces New Fall-Winter Courses
September 29, 2011
Barnett Educational Services Announces Buy One, Get One Free DVD Sale!
June 6, 2011

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What's the Strategy Behind Strategic Partnerships?

Have you noticed a lot of "buzz" around the topic of strategic partnerships and alliances over the past few years? Have you wondered, like I have, exactly what do these terms mean? For an overview and some thoughts on what it all means to clinical research professionals, keep reading. According to the website diction

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SAM is the author of the all new HIPAA and US Clinical Trials: A Q&A Reference Guide 2014 and the long-time HIPAA subject matter expert to the Good Clinical Practice: Q&A Reference Guide. In this podcast, SAM tells us what’s new in the GCP Guide, and how the new HIPAA-specific reference guide delves deeper into the requirements, definitions, authorizations and enforcement of HIPAA. She’ll tell us how the book dispels common myths about HIPAA, and how HIPAA impacts risk-based monitoring activities like remote review of source.

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