Computer Systems Validation In Clinical Research
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Computer Systems Validation In Clinical Research
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Author : ACDM/PSI Working Party on Computer Systems Validation
language : en
Publisher:
Release Date : 1997
Computer Systems Validation In Clinical Research written by ACDM/PSI Working Party on Computer Systems Validation and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with categories.
Computer System Validation
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Author : Mindy Allport-Settle
language : en
Publisher: PharmaLogika Books
Release Date : 2021-03-31
Computer System Validation written by Mindy Allport-Settle and has been published by PharmaLogika Books this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-03-31 with categories.
Computer Systems Validation
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Author : Guy Wingate
language : en
Publisher: CRC Press
Release Date : 2003-12-18
Computer Systems Validation written by Guy Wingate and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-12-18 with Medical categories.
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality
Pharmaceutical Computer Systems Validation
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Author : Guy Wingate
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Pharmaceutical Computer Systems Validation written by Guy Wingate and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
G3p Good Privacy Protection Practice In Clinical Research
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Author : Karl-Heinz Schriever
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2014-10-02
G3p Good Privacy Protection Practice In Clinical Research written by Karl-Heinz Schriever and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-02 with Medical categories.
Establishing ethical and privacy protection aspects in scientific research, especially in medical research, has a long history. Medical data are usually more sensible than other personal data and require therefore an even higher degree of protection than other personal data. In recent research projects genetic evaluations become more and more important and trigger thereby new and continuing activities in the context of data protection. Genetic data as a subset of medical data are the most sensible category of personal data and require therefore the highest degree of data protection. The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Technical requirements and aspects of data protection including pseudonymization and anonymization procedures taking into account ethics committees requirements as well as the underlying legal framework are also presented. Without any exception, all principles and methods presented are best practices, repeatedly applied in different clinical environments and by no means theoretical considerations.
Clinical Trials Handbook
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2009-06-17
Clinical Trials Handbook written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-06-17 with Science categories.
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
Eu Annex 11 Guide To Computer Validation Compliance For The Worldwide Health Agency Gmp
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Author : Orlando Lopez
language : en
Publisher: CRC Press
Release Date : 2015-04-06
Eu Annex 11 Guide To Computer Validation Compliance For The Worldwide Health Agency Gmp written by Orlando Lopez and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-06 with Business & Economics categories.
Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is
Validating Clinical Trial Data Reporting With Sas
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Author : Carol I. Matthews
language : en
Publisher: SAS Institute
Release Date : 2008
Validating Clinical Trial Data Reporting With Sas written by Carol I. Matthews and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Computers categories.
This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration.
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1999-08-27
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-08-27 with Medical categories.
In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Good Clinical Laboratory And Manufacturing Practices
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Author : Phillip A. Carson
language : en
Publisher: Royal Society of Chemistry
Release Date : 2007
Good Clinical Laboratory And Manufacturing Practices written by Phillip A. Carson and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Science categories.
Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.