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Taken from the NEW Good Clinical Practice: A Question & Answer Guide 2014. 

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Question: In 2013, there was controversy regarding a study involving neonatal research and the adequacy of the informed consent provided during the trial. What were the issues in this case?  

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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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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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GCP and Clinical Research Standards in Latin America, May 2014
Exclusive Interview with Anne Blanchard and Paula Valeria Casasco 

 

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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e-Clinical Trials, Electronic Records, and e-Data Regulations, May 2014
Exclusive Interview with Teri Stokes, Ph.D., GXP International 

 

This podcast is for those who seek guidance on the challenges and concerns related to computerized systems and their impact on site and sponsor personnel. In this interview, common sense computer validation services and training product expert Dr. Teri Stokes discusses her chapter in the GCP Q&A Guide, "e-Clinical Trials, Electronic Records, and e-Data Regulations,” including the two new FDA Final Guidance Documents related to Electronic Source Data and Risk-Based Monitoring.

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Updates to the Good Clinical Practice Question & Answer Reference Guide are addressed in this exclusive podcast. In this interview, editor Michael Hamrell gives a sneak peek into the regulatory landscape in 2014, and the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. A must-have resource for CRAs, investigators/sites, auditors, compliance, legal, and other clinical research professionals, the Q&A Guide answers hundreds of questions about GCP.

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Medical Device Development: Regulation and Law 2014 – Part 1
Exclusive Interview with Jonathan Kahan and Michael Heyl  

 

In Part One of this podcast series, the authors provide an overview of the 2014 edition of this must-have, authoritative text. This podcast offers a glimpse into the book’s comprehensive analysis of new FDA device legislation and over a dozen important new guidances, and addresses how emerging developments and trends are reshaping medical device and combination product regulations in the U.S. This interview provides an introduction to future podcast topics that will specifically address issues such as changes to the 510(k) process, the new refusal to accept policy, changes to the post-market side, the evolution of the de novo downclassification process, updates to the humanitarian device exemption requirements, new and significant changes to how FDA handles custom devices, as well as new trends in mobile applications and how FDA regulates medical device software.

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The PAREXEL Biopharmaceutical R&D Statistical Sourcebook is the industry's leading resource for statistics, trends, and proprietary market intelligence and analysis on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analyses, the Sourcebook provides the latest intelligence on every aspect of biopharmaceutical development – from product discovery, to R&D performance and productivity, to time-to-market analysis. Mark Mathieu is the Editor of the Sourcebook, and director of strategic research at PAREXEL Consulting. In this interview, he discusses the emerging metrics and benchmarks on the current state and direction of today's biopharm industry, industry activity in clinical development, metrics by therapeutic area, and clinical trials in emerging markets.

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The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Exclusive Interview with Sam Sather, MS, BSN, CCRA, CCRC 

 

Happy Birthday, HIPAA! This exclusive podcast is with Sandra "Sam" Sather, MS, BSN, CCRA, CCRC, Founder of Clinical Pathways, LLC. Sam is the author of the GCP Question & Answer Reference Guide's section on "The HIPAA Privacy Rule and FDA-Regulated Clinical Trials." Hear Sam discuss the Omnibus HIPAA Rulemaking and HITECH, as well as strategies for sites, sponsors, CROs, and IRBs.

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GCP and Clinical Research Standards in the European Union
Exclusive Interview with Dr. Beat Widler 

 

This exclusive podcast is with Dr. Beat Widler, the key contributor to this year's GCP Q&A Guide's Chapter on "GCP and Clinical Research Standards in the European Union." Hear Dr. Widler's take on issues such as global outsourcing, the pitfalls and opportunities related to global drug development, and the sharing of protocols and protocol standards across industry.

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FROM THE BARNETT BOOKSHELF 

Good Clinical Practice: A Q&A Reference Guide 2014 (Hard Copy) 

Good Clinical Practice: A Q&A Reference Guide 2014 (Electronic Edition) 

PAREXEL Biopharmaceutical Statistical Sourcebook 2014/2015 (Hardcopy) 

PAREXEL Biopharmaceutical Statistical Sourcebook 2014/2015 (eStats) 

CFR ICH GCP Reference Guide for Medical Devices 2014 (Spiral Bound) 

CFR ICH GCP Reference Guide 2014 (Spiral Bound) 


 

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