Conducting Gcp Compliant Clinical Research

Download or read book Conducting GCP-Compliant Clinical Research written by Wendy Bohaychuk and published by John Wiley & Sons. This book was released on 1999-06-02 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Conducting GCP-Compliant Clinical Research written by Wendy Bohaychuk and published by John Wiley & Sons. This book was released on 1999-06-02 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Principles and Practice of Pharmaceutical Medicine written by Andrew J. Fletcher and published by John Wiley & Sons. This book was released on 2003-01-31 with total page 558 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practice of Pharmaceutical Medicine begins with a detailed overview of its origins, and goes on to examine current career opportunities, education and training. Encompassing the entire spectrum of pharmaceutical medicine, it also discusses international drug development and registration, including animal toxicology and human volunteers, pharmacoeconomics and statistics, medical services, legal and ethical issues and business aspects. It is the most up-to-date guide to drug development and marketing, and the only book with an international outlook. * The authors are all experts in their field and include an assessment of the current status of their specialities * This book provides an insight into how things may develop in the future * It is designed to be a guide for those who are actually practicing pharmaceutical medicine

Download or read book Principles and Practice of Pharmaceutical Medicine written by Lionel D. Edwards and published by John Wiley & Sons. This book was released on 2007-04-30 with total page 780 pages. Available in PDF, EPUB and Kindle. Book excerpt: The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Download or read book Encyclopedia of Health Care Management written by Michael J. Stahl and published by SAGE Publications. This book was released on 2003-10-21 with total page 665 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The most comprehensive one-volume reference work on health care management published in the last 10 years, this work brings together much useful information and will appeal to a broad audience. Health science libraries, college libraries, and large public libraries will want to invest in this title." --BOOKLIST "This volume should be considered by academic and public libraries with large healthcare management or business collections as the only current reference on this topic." --LIBRARY JOURNAL "The Encyclopedia of Health Care Management would be useful for those involved in any aspect of health care, whether as a student, instructor, practitioner, researcher, or administrator. This book would be of great use in reference collections at public, university, hospital, and corporate libraries." --E-STREAMS Health care is one of today′s most discussed and debated topics. From issues such as accessibility to costs to quality, the debates range widely among doctors, patients, employers, and insurers. A popular topic in political campaigns and the media, health care and health care management is also a quiet and unremitting concern in the private and personal lives of individuals who worry about someday having to choose between food and prescription drugs. For this reason, in today′s health care industry, good business practices may be as important as the practice of medicine in assuring the continued health of the industry. The Encyclopedia of Health Care Management will prove invaluable to libraries serving students and professionals in health and business. It will also be an essential reference for physicians, providers and their employees, and students and professors in health and management for responsible and successful practice and administration in the health care industry. This encyclopedia is the most comprehensive reference work on the business of health care, with up-to-date information across a broad range of issues affecting every aspect of the industry and the people it serves, employs, and influences. Key Features The most comprehensive reference work on health care management Broad range of timely topics, spanning academic, corporate and governmental arenas Over 600 entries More than 160 expert contributors in the fields of medicine, public health, and business Tables on Health Care Acronyms Medical Degrees Medical Legislation Medical Organizations Medical Specialties About the Editor Michael J. Stahl, Ph.D. is Director of the Physician Executive MBA Program and Distinguished Professor of Management in the College of Business at the University of Tennessee, Knoxville. Dr. Stahl received his B.S. in Electrical Engineering from the State University of NY at Buffalo and his Ph.D. in Management from Rensselaer Polytechnic Institute. From 1982-1989, Stahl was Head of the Management Department at Clemson University He was Associate Dean in the College of Business at the University of Tennessee from 1989-1997. Dr. Stahl has published over 50 journal articles in a variety of areas including Strategic Management, TQ, and healthcare, as well as twelve books including Strategic Management, Perspectives in TQ, and The Physician′s Essential MBA. He teaches strategy and business planning in the Physician EMBA, Taiwan EMBA, and MBA Programs. Recommended Libraries Academic, Public, Special, Private/Corporate

Download or read book Clinical Trials Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2009-06-17 with total page 1247 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Good Practice of Clinical Drug Trials written by Alain Spriet and published by LIBRAIRIE LUGINBUHL. This book was released on 2005 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition of `Good Practice' is a totally revised and expanded version of this work. It takes into account the new quality guidelines, in particular those listed in the European Union Directive, the application texts and the recommendations of the International Conference on Harmonisation (ICH). It is a practical manual to help you conduct your clinical trials. Many new or revised concepts have been included, in particular: - Rationale for each rule presented - Safety of data in clinical trials - Protection of personal data - Conflicts of interest - Measures to be taken in case of suspected fraud