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Author: Wendy Bohaychuk
Publisher: John Wiley & Sons
ISBN: 9780471988243
Category : Medical
Languages : en
Pages : 234
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Book Description
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.
Author: Wendy Bohaychuk
Publisher: John Wiley & Sons
ISBN: 9780471988243
Category : Medical
Languages : en
Pages : 234
Get Book Here
Book Description
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.
Author: Michael J. McGraw
Publisher: Pharmaceutical Press
ISBN: 0853697906
Category : Business & Economics
Languages : en
Pages : 273
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Book Description
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.
Author: Vera Mihajlovic-Madzarevic
Publisher: John Wiley & Sons
ISBN: 0470920882
Category : Medical
Languages : en
Pages : 186
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Book Description
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
Author: Chinese University of Hong Kong
Publisher:
ISBN: 9789881904119
Category : Clinical trials
Languages : en
Pages : 153
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Book Description
The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
Author: Natasha Martien
Publisher: Academic Press
ISBN: 0128162430
Category : Medical
Languages : en
Pages : 278
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Book Description
A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. - Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) - Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process - Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits - Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. - Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject's needs urgently and compliantly
Author: Andrew J. Fletcher
Publisher: John Wiley & Sons
ISBN: 0470851716
Category : Medical
Languages : en
Pages : 558
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Book Description
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
Author: Milica Prostran
Publisher: BoD – Books on Demand
ISBN: 1789232007
Category : Medical
Languages : en
Pages : 226
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Book Description
This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.
Author: Lionel D. Edwards
Publisher: John Wiley & Sons
ISBN: 9780470093146
Category : Medical
Languages : en
Pages : 780
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Book Description
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
Author: Celine Clive
Publisher: CRC Press
ISBN: 9780849321818
Category : Medical
Languages : en
Pages : 288
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Book Description
Completely revised and updated, the second edition of a classic reference, Handbook of SOPs for Good Clinical Practice provides templates of SOPs ready for adaptation to your requirements and immediate use. This allows you to create new SOPs or benchmark your existing SOPs against an internationally accepted set of SOPs. The book includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that you can easily customize the text to reflect your organization's processes. The author uses language ranging from the specific to the very general, depending on the activity described and the number of the existing regulations governing the activity. This provides you with a starting point for the development of your organization's SOPs, saving you the time and money that would normally be spent researching and documenting each of the procedures described. Modifying the SOPs supplied by this book will be a much more efficient task than developing new ones from scratch. Containing templates for SOPs and forms applicable to sponsors, study sites, and Institutional Review Boards (IRBs), Handbook of SOPs for Good Clinical Practice, Second Edition gives you the tools needed to develop effective SOPs for your organization.
Author: Michael J. Stahl
Publisher: SAGE Publications
ISBN: 1452265240
Category : Medical
Languages : en
Pages : 665
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Book Description
"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
