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 ...
Author: Wendy Bohaychuk
Publisher: John Wiley & Sons
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.
The aim of this chapter is to describe the general framework for conducting good clinical practices (GCP)-compliant clinical research, particularly pharmaceutical industry clinical research. Since it is difficult to cover this broad ...
Author: Andrew J. Fletcher
Publisher: John Wiley & Sons
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
India and China have been identified by pharmaceutical companies as the future markets that would support drug research and development in a cost efficient manner. This has become necessary as resources to conduct clinical studies dwindle, coupled with the fact that pharmaceutical industries are under pressure to deliver quality medicine, on time, to the public. Exploring and examining India and China's potential in a stepwise fashion provides the opportunity to dissect the good, the bad and the ugly of globalization in a comparative approach. This paper will cover areas like ethics in the conduct of studies, good clinical practice (GCP), economic realities, ICH influence, intellectual property security and the role of government in global clinical trial.
Conducting GCP-compliant clinical research is a serious undertaking, and this has been recognized by numerous authorities internationally. It is difficult to achieve a fully GCP-compliant clinical study, but the expectation today is ...
Author: Lionel D. Edwards
Publisher: John Wiley & Sons
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
These principles provide the framework for conducting GCP-compliant clinical research. Many systems and procedures must be established and put into place before the start of a clinical trial study. This practice ensures that the ...
Author: Michael J. Stahl
Publisher: SAGE Publications
The topic of health care management has escalated to one of the most widely discussed and debated topics in the health care industry, MBA programs, and in the field of medicine in general. In the 1980s, the industry was relatively stable and the need for combining business acumen with medicine was less than today. However, as we enter the 21st century, the need for applying business and management skills to the health care industry is stronger than ever. This Encyclopedia covers every topic a medical professional, institutional administrator, or MBA student would need to know about the business of health care. Key Features * Over 600 entries * More than 160 expert contributors from the fields of medicine, public health, business * Tables on medical degrees, medical specialties, medical organizations, health care acronyms, medical legislation * Unites the business and medical worlds, and spans the academic, corporate, and governmental arenas Topics Covered Accounting and Activity-Based Costing / Economics / Finance / Health Policy / Human Resources / Information Technology / Institutions and Organizations / International Health Care Issues / Legal and Regulatory Issues / Managed Care / Marketing and Customer Value / Operations and Decision Making / Pharmaceuticals and Clinical Trials / Quality / Statistics and Data Mining / Strategy
The following texts about the management of clinical trials may also provide useful information. Rondel, R. K., Varley, S. A. ... Bohaychuk, W. and Ball, G., Conducting GCP-Compliant Clinical Research, John Wiley & Sons, New York, 1999.
Author: Eleanor McFadden
Publisher: John Wiley & Sons
A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of "off-the-shelf" solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.
... and improve on the timeliness of good clinical quality processes and outcomes that can be defined and measured. REFERENCES Bohaychuk, W., and Ball, G. (2001), Conducting GCP-compliant Clinical Research, Wiley, New York, p. 127. 1.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
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.
Clinical quality assurance - a defined role ( Editorial ) . Pharmaceut Med 1988 ; 3 : 305-307 . 2. ... DIA to offer certification to clinical investigators . ... Bohaychuk W , Ball G. Conducting GCP - compliant clinical research .
Author: Alain Spriet
Publisher: LIBRAIRIE LUGINBUHL
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
This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic.
Author: Natasha Martien
Publisher: Academic Press
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 (https://www.elsevier.com/books-and-journals/book-companion/9780128162422), so that study teams will be compliant and will find all the necessary tools within this book. 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
Pharmacy and Clinical Development Bohaychuk, W. and Ball, G. (1999). Conducting GCP-Compliant Clinical Research: A Practical Guide. Chichester: Wiley. Day, S. (2007). Dictionary for Clinical Trials, 2e. Chichester: Wiley. Gad, S.C. (ed.) ...
Author: Stefan Behme
Publisher: John Wiley & Sons
Now in its third edition, the text covers all aspects of biopharmaceutical manufacturing. Structured like a textbook, it is aimed at a wide audience in industry and academia and can be used as a reference as well as for training purposes.