Writing And Managing Sops For Gcp
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Writing And Managing Sops For Gcp
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2015-07-29
Writing And Managing Sops For Gcp written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-29 with Computers categories.
Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focus
Writing And Managing Sops For Gcp
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2015-07-29
Writing And Managing Sops For Gcp written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-29 with Computers categories.
This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focused on the practical aspects of SOPs and SOP management.
Conducting Gcp Compliant Clinical Research
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Author : Wendy Bohaychuk
language : en
Publisher: John Wiley & Sons
Release Date : 1999-06-02
Conducting Gcp Compliant Clinical Research written by Wendy Bohaychuk 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 1999-06-02 with Medical categories.
Conducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including: Standard operating procedures for investigators Standard operating procedures for sponsors and CROs GCP - an indexed reference Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.
Practical Guide To Clinical Data Management
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2024-07-03
Practical Guide To Clinical Data Management written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-03 with Medical categories.
The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers. Features: Provides an introduction and background information for the spectrum of clinical data management tasks. Outstanding text in the industry and has been used by the Society for Clinical Data Management in creating its certification exam. Explains the high-level flow of a clinical trial from creation of the protocol through study lock. Reflects electronic data capture and interactive response technologies. Discusses using the concept of three phases in the clinical data management of a study: study startup, study conduct, and study closeout, to write procedures and train staff.
The Fundamentals Of Clinical Research
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Author : P. Michael Dubinsky
language : en
Publisher: John Wiley & Sons
Release Date : 2022-01-26
The Fundamentals Of Clinical Research written by P. Michael Dubinsky 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 2022-01-26 with Medical categories.
This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
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.
Global Clinical Trials Playbook
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Author : Menghis Bairu
language : en
Publisher: Academic Press
Release Date : 2012-06-12
Global Clinical Trials Playbook written by Menghis Bairu and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-12 with Medical categories.
Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. - Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world - Provides real world international examples which illustrate the practical translation of principles - Includes forms, templates, and additional references for standardization in a number of global scenarios
Master Of Technology In Transportation Engineering
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Author : Mr. Rohit Manglik
language : en
Publisher: EduGorilla Publication
Release Date : 2024-03-18
Master Of Technology In Transportation Engineering written by Mr. Rohit Manglik and has been published by EduGorilla Publication this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-03-18 with Transportation categories.
EduGorilla Publication is a trusted name in the education sector, committed to empowering learners with high-quality study materials and resources. Specializing in competitive exams and academic support, EduGorilla provides comprehensive and well-structured content tailored to meet the needs of students across various streams and levels.
Good Clinical Laboratory And Manufacturing Practices
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Author : Philip Carson
language : en
Publisher: Royal Society of Chemistry
Release Date : 2007-10-31
Good Clinical Laboratory And Manufacturing Practices written by Philip 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 2007-10-31 with Science categories.
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Clinical Trial Project Management
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Author : Ashok Kumar Peepliwal
language : en
Publisher: Elsevier
Release Date : 2023-11-15
Clinical Trial Project Management written by Ashok Kumar Peepliwal and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-15 with Business & Economics categories.
Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. - Covers how to conduct clinical trials in detail - Present useful, basic, and advanced statistical tools - Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book