Practical Guide to Clinical Data Management PDF Download
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Author: Susanne Prokscha
Publisher: CRC Press
ISBN: 1439848319
Category : Computers
Languages : en
Pages : 278
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Book Description
The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then,
Author: Susanne Prokscha
Publisher: CRC Press
ISBN: 1439848319
Category : Computers
Languages : en
Pages : 278
Get Book Here
Book Description
The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then,
Author: Eleanor McFadden
Publisher: John Wiley & Sons
ISBN: 0470181273
Category : Mathematics
Languages : en
Pages : 206
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Book Description
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.
Author: National Research Council
Publisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163
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Book Description
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: MARK. ELSLEY
Publisher:
ISBN: 9781912055210
Category :
Languages : en
Pages : 46
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Book Description
Author: JoAnn Pfeiffer
Publisher: CRC Press
ISBN: 1315299771
Category : Mathematics
Languages : en
Pages : 292
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Book Description
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Author: Florian Leiner
Publisher: Springer Science & Business Media
ISBN: 9780387951591
Category : Computers
Languages : en
Pages : 230
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Book Description
Medical Data Management is a systematic introduction to the basic methodology of professional clinical data management. It emphasizes generic methods of medical documentation applicable to such diverse tasks as the electronic patient record, maintaining a clinical trials database, and building a tumor registry. This book is for all students in medical informatics and health information management, and it is ideal for both the undergraduate and the graduate levels. The book also guides professionals in the design and use of clinical information systems in various health care settings. It is an invaluable resource for all health care professionals involved in designing, assessing, adapting, or using clinical data management systems in hospitals, outpatient clinics, study centers, health plans, etc. The book combines a consistent theoretical foundation of medical documentation methods outlining their practical applicability in real clinical data management systems. Two new chapters detail hospital information systems and clinical trials. There is a focus on the international classification of diseases (ICD-9 and -10) systems, as well as a discussion on the difference between the two codes. All chapters feature exercises, bullet points, and a summary to provide the reader with essential points to remember. New to the Third Edition is a comprehensive section comprised of a combined Thesaurus and Glossary which aims to clarify the unclear and sometimes inconsistent terminology surrounding the topic.
Author: Richard K. Rondel
Publisher: John Wiley & Sons
ISBN: 9780471983293
Category : Medical
Languages : en
Pages : 386
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Book Description
Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.
Author: Prakash Nadkarni
Publisher: Academic Press
ISBN: 012803145X
Category : Science
Languages : en
Pages : 242
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Book Description
Clinical Research Computing: A Practitioner's Handbook deals with the nuts-and-bolts of providing informatics and computing support for clinical research. The subjects that the practitioner must be aware of are not only technological and scientific, but also organizational and managerial. Therefore, the author offers case studies based on real life experiences in order to prepare the readers for the challenges they may face during their experiences either supporting clinical research or supporting electronic record systems. Clinical research computing is the application of computational methods to the broad field of clinical research. With the advent of modern digital computing, and the powerful data collection, storage, and analysis that is possible with it, it becomes more relevant to understand the technical details in order to fully seize its opportunities. - Offers case studies, based on real-life examples where possible, to engage the readers with more complex examples - Provides studies backed by technical details, e.g., schema diagrams, code snippets or algorithms illustrating particular techniques, to give the readers confidence to employ the techniques described in their own settings - Offers didactic content organization and an increasing complexity through the chapters
Author: Menghis Bairu
Publisher: Academic Press
ISBN: 0124158609
Category : Medical
Languages : en
Pages : 332
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Book Description
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
