Good Clinical Practice A Question Answer Reference Guide May 2013

Author : Michael R. Hamrell
Publisher :
ISBN 13 : 9780988314429
Total Pages : 0 pages
Book Rating : 4.28/5 ( download)

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Download or read book Good Clinical Practice: A Question & Answer Reference Guide, May 2013 written by Michael R. Hamrell and published by . This book was released on 2013-05 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Featuring An All-New Index of Topics! This industry-leading GCP training and reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of US and international GCP standards for drugs, biologics, and medical device clinical trials. And, in response to popular demand, the 2013 edition features an all-new index, making topic research easier than ever before. The completely updated and expanded 2013 guide includes: Input from an Expert Advisory Panel including distinguished international GCP experts who have assured that the book contains the most current and up-to-date information on global GCP requirements. Over 100 new Q&As, including questions addressing key topics such as risk-based approaches to monitoring clinical trials, and new changes and information to be provided in informed consent documents. Revisions and updates to the section on HIPAA and privacy on this tenth anniversary of the implementation of the law. Updated information on electronic records and use of EMR in clinical research. Completely updated sections featuring all the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. 200+ Q&As updated to reflect the very latest FDA guidances, regulations, comments, and developments. Revised and updated sections on GCP compliance and clinical trial requirements in numerous regions of the world outside the US. Updates to information on Latin America, India, Russia, Ukraine, and China, and the addition of GCP information for Canada. Read how the FDA is focusing more intently on sponsors' quality systems when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. About Barnett's GC

Author : Michael R. Hamrell
Publisher :
ISBN 13 : 9780988314474
Total Pages : 724 pages
Book Rating : 4.79/5 ( download)

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Download or read book Good Clinical Practice: A Question & Answer Rference Guide, May 2014 written by Michael R. Hamrell and published by . This book was released on 2014-05-01 with total page 724 pages. Available in PDF, EPUB and Kindle. Book excerpt: Featuring An All-New Index of Topics! This industry-leading GCP training and reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of US and international GCP standards for drugs, biologics, and medical device clinical trials. And, in response to popular demand, the 2013 edition features an all-new index, making topic research easier than ever before. The completely updated and expanded 2013 guide includes: Input from an Expert Advisory Panel including distinguished international GCP experts who have assured that the book contains the most current and up-to-date information on global GCP requirements. Over 100 new Q&As, including questions addressing key topics such as risk-based approaches to monitoring clinical trials, and new changes and information to be provided in informed consent documents. Revisions and updates to the section on HIPAA and privacy on this tenth anniversary of the implementation of the law. Updated information on electronic records and use of EMR in clinical research. Completely updated sections featuring all the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. 200+ Q&As updated to reflect the very latest FDA guidances, regulations, comments, and developments. Revised and updated sections on GCP compliance and clinical trial requirements in numerous regions of the world outside the US. Updates to information on Latin America, India, Russia, Ukraine, and China, and the addition of GCP information for Canada. Read how the FDA is focusing more intently on sponsors' quality systems when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. About Barnett's GC

Author : Earl W. Hulihan
Publisher :
ISBN 13 : 9780996346283
Total Pages : 0 pages
Book Rating : 4.87/5 ( download)

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Download or read book Good Clinical Practice written by Earl W. Hulihan and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Munish Mehra
Publisher : Barnett International, LLC
ISBN 13 : 9781882615902
Total Pages : 0 pages
Book Rating : 4.05/5 ( download)

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Download or read book Good Clinical Practice written by Munish Mehra and published by Barnett International, LLC. This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Mark P. Mathieu, Ed.
Publisher :
ISBN 13 : 9781882615988
Total Pages : pages
Book Rating : 4.80/5 ( download)

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Download or read book Good Clinical Practice: A Question & Answer Reference Guide, May 2012 written by Mark P. Mathieu, Ed. and published by . This book was released on 2012-05-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Munish Mehra
Publisher :
ISBN 13 : 9781882615865
Total Pages : 0 pages
Book Rating : 4.67/5 ( download)

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Download or read book Good Clinical Practice written by Munish Mehra and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Mark P. Mathieu
Publisher :
ISBN 13 : 9781882615957
Total Pages : 0 pages
Book Rating : 4.56/5 ( download)

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Download or read book Good Clinical Practice: A Question & Answer Reference Guide, May 2011 written by Mark P. Mathieu and published by . This book was released on 2011-05 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good clinical practice (GCP) is a set of broad FDA regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research. Interpreting and implementing GCP standards continue to represent challenges for pharmaceutical, biotechnology, and medical device industries. This publication sets out to systematically collect, catalog, and answer the most important, emerging, and difficult questions regarding the interpretation and implementation of GCP standards today. This text's question-and-answer format, address a vast array of these questions, some of which have persisted for many years without definitive answers and some of which have emerged in response to new clinical trials or regulatory related developments.

Author : Gary L. Chadwick
Publisher :
ISBN 13 : 9780988193802
Total Pages : 216 pages
Book Rating : 4.09/5 ( download)

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Download or read book Good Clinical Practice Guide written by Gary L. Chadwick and published by . This book was released on 2012-09-17 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Good Clinical Practice (GCP) Guide is a logical extension of the CITI Program's web-based Good Clinical Practice (GCP) training, and is based on the CITI Program's recognized content. It is intended to serve as a quick reference guide for GCP using Drugs and Biologics as well as Devices.

Author : Sheldon Rubenfeld
Publisher : Springer
ISBN 13 : 3319057022
Total Pages : 308 pages
Book Rating : 4.26/5 ( download)

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Download or read book Human Subjects Research after the Holocaust written by Sheldon Rubenfeld and published by Springer. This book was released on 2014-06-30 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: “An engaging, compelling and disturbing confrontation with evil ...a book that will be transformative in its call for individual and collective moral responsibility." – Michael A. Grodin, M.D., Professor and Director, Project on Medicine and the Holocaust, Elie Wiesel Center for Judaic Studies, Boston University Human Subjects Research after the Holocaust challenges you to confront the misguided medical ethics of the Third Reich personally, and to apply the lessons learned to contemporary human subjects research. While it is comforting to believe that Nazi physicians, nurses, and bioscientists were either incompetent, mad, or few in number, they were, in fact, the best in the world at the time, and the vast majority participated in the government program of “applied biology.” They were not coerced to behave as they did—they enthusiastically exploited widely accepted eugenic theories to design horrendous medical experiments, gas chambers and euthanasia programs, which ultimately led to mass murder in the concentration camps. Americans provided financial support for their research, modeled their medical education and research after the Germans, and continued to perform unethical human subjects research even after the Nuremberg Doctors’ Trial. The German Medical Association apologized in 2012 for the behavior of its physicians during the Third Reich. By examining the medical crimes of human subjects researchers during the Third Reich, you will naturally examine your own behavior and that of your colleagues, and perhaps ask yourself "If the best physicians and bioscientists of the early 20th century could do evil while believing they were doing good, can I be certain that I will never do the same?"

Author : eRegs & Guides
Publisher : eRegs And Guides
ISBN 13 :
Total Pages : 365 pages
Book Rating : 4./5 ( download)

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Download or read book Good Clinical Practice eRegs & Guides - For Your Reference Book 2 written by eRegs & Guides and published by eRegs And Guides. This book was released on 2013-11-22 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: E6 Good Clinical Practice Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application CFR 21-- General Part 11, Electronic Records; Electronic Signatures 21 CFR PART 50 Protection Of Human Subjects 21 CFR Part 54 Financial Disclosure By Clinical Investigators 21 CFR PART 56 Institutional Review Boards Title 21 PART 312 Investigational New Drug Application ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting ICH E8 General Considerations For Clinical Trials