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

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Question: In discussing clinical data quality and good documentation practices, a concept called the “ALCOA standard” is sometimes cited by FDA GCP compliance officials. What is this standard, and does the FDA recognize it either officially or unofficially?

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HIPAA and US Clinical Trials
Exclusive Interview with Sam Sather, MS, BSN, CCRA, CCRC

 

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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In this discussion, our regional experts address the growth, challenges, and opportunities of conducting clinical trials in Latin America. Specifically, we get insights into the common aspects of the regulatory process for the review and approval of clinical trials in Latin America, the challenges sponsors face in obtaining approval to conduct clinical trials, and how the region’s regulatory authorities monitor GCP compliance standards.

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PAREXEL Biopharmaceutical Statistical Sourcebook 2015/2016 (Hardcopy)

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CFR ICH GCP Reference Guide for Medical Devices 2015 (Spiral Bound)

CFR ICH GCP Reference Guide 2015 (Spiral Bound)


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