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Quick Guide to Good Clinical Practice

2016-11-15 Medical
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Release : 2016-11-15
Genre : Medical
Kind : eBook
Book Rating : 445/5 ( reviews)

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Book Synopsis Quick Guide to Good Clinical Practice by : Cemal Cingi

Download or read book Quick Guide to Good Clinical Practice written by Cemal Cingi. This book was released on 2016-11-15. Available in PDF, EPUB and Kindle. Book excerpt: This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.

Good Clinical Practice

1998 Medical
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Release : 1998
Genre : Medical
Kind : eBook
Book Rating : /5 ( reviews)

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Book Synopsis Good Clinical Practice by : Josef Kolman

Download or read book Good Clinical Practice written by Josef Kolman. This book was released on 1998. Available in PDF, EPUB and Kindle. Book excerpt: Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC - Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional Services in Clinical Research, Edinburgh, Scotland There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * An explanation of what standard operating procedures are and how they work * A selection of actual standard operating procedures and checklists This well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.

Good Clinical Practice Guide

2012-06 Clinical medicine
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Release : 2012-06
Genre : Clinical medicine
Kind : eBook
Book Rating : 079/5 ( reviews)

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Book Synopsis Good Clinical Practice Guide by :

Download or read book Good Clinical Practice Guide written by . This book was released on 2012-06. Available in PDF, EPUB and Kindle. Book excerpt: Efforts to control atmospheric accumulations of greenhouse gases that threaten to heat up the planet are in their infancy. Although the IMF is not an environmental organization, environmental issues matter for the organization's mission when they have major implications for macroeconomic performance and fiscal policy. Climate change clearly passes both these tests. This volume provides practical guidelines for the design of fiscal policies (carbon taxes and emissions trading systems with allowance auctions) to reduce greenhouse gases. Not only are these instruments potentially the most effective at exploiting emission reduction opportunities in the near and longer term, but they can also generate for many countries a valuable new source of government revenue. The chapters, written by leading experts, explain the case for fiscal policies over other approaches; how these policies can be implemented; reasonable levels for emissions prices; policies for the forest sector; appropriate polic

Clinical Trials Audit Preparation

2010-09-29 Medical
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Release : 2010-09-29
Genre : Medical
Kind : eBook
Book Rating : 882/5 ( reviews)

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Book Synopsis Clinical Trials Audit Preparation by : Vera Mihajlovic-Madzarevic

Download or read book Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic. This book was released on 2010-09-29. Available in PDF, EPUB and Kindle. Book excerpt: A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development

Principles of Good Clinical Practice

2010 Business & Economics
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Release : 2010
Genre : Business & Economics
Kind : eBook
Book Rating : 906/5 ( reviews)

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Book Synopsis Principles of Good Clinical Practice by : Michael J. McGraw

Download or read book Principles of Good Clinical Practice written by Michael J. McGraw. This book was released on 2010. Available in PDF, EPUB and Kindle. Book excerpt: Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.

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