Practical Guide to Clinical Data Management

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Author :
Publisher : CRC Press
ISBN 13 : 1439848319
Total Pages : 296 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Practical Guide to Clinical Data Management by : Susanne Prokscha

Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 2011-10-26 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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,

Clinical Data Management

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 9780471983293
Total Pages : 386 pages
Book Rating : 4.9/5 (832 download)

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Book Synopsis Clinical Data Management by : Richard K. Rondel

Download or read book Clinical Data Management written by Richard K. Rondel and published by John Wiley & Sons. This book was released on 2000-02-03 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Data Management

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 9780387951591
Total Pages : 230 pages
Book Rating : 4.9/5 (515 download)

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Book Synopsis Medical Data Management by : Florian Leiner

Download or read book Medical Data Management written by Florian Leiner and published by Springer Science & Business Media. This book was released on 2003-01-14 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Fundamentals of Clinical Data Management

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Author :
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781516986576
Total Pages : 0 pages
Book Rating : 4.9/5 (865 download)

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Book Synopsis The Fundamentals of Clinical Data Management by : S. Fernandez

Download or read book The Fundamentals of Clinical Data Management written by S. Fernandez and published by Createspace Independent Publishing Platform. This book was released on 2015-08-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Fundamentals of Clinical Data Management" is a manual for Sponsors, CROs, Investigators, Clinical Trial Monitors and Managers and Clinical Research Professionals to learn the basic concepts of Clinical Data Management. This book will focus on the topic which includes: Clinical Information Flow, Roles and Responsibilities of CDM Personnel, Guidelines Associated with CDM, Data Management Plan, CRF Designing, Data Collection, Cleaning and Data Validation, Study setup and Database Designing, Laboratory Data and Adverse Event Data Management, Report Creation and Data Closure, Data Archiving, Privacy and Security etc.

A Guide to GCP for Clinical Data Management

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Author :
Publisher :
ISBN 13 : 9781912055210
Total Pages : 46 pages
Book Rating : 4.0/5 (552 download)

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Book Synopsis A Guide to GCP for Clinical Data Management by : MARK. ELSLEY

Download or read book A Guide to GCP for Clinical Data Management written by MARK. ELSLEY and published by . This book was released on 2017 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Fundamentals of Clinical Data Science

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Author :
Publisher : Springer
ISBN 13 : 3319997130
Total Pages : 219 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis Fundamentals of Clinical Data Science by : Pieter Kubben

Download or read book Fundamentals of Clinical Data Science written by Pieter Kubben and published by Springer. This book was released on 2018-12-21 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.

Sharing Clinical Trial Data

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Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 304 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Clinical Analytics and Data Management for the DNP, Second Edition

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Author :
Publisher : Springer Publishing Company
ISBN 13 : 0826142788
Total Pages : 396 pages
Book Rating : 4.8/5 (261 download)

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Book Synopsis Clinical Analytics and Data Management for the DNP, Second Edition by : Martha L. Sylvia, PhD, MBA, RN

Download or read book Clinical Analytics and Data Management for the DNP, Second Edition written by Martha L. Sylvia, PhD, MBA, RN and published by Springer Publishing Company. This book was released on 2018-03-28 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition: “DNP students may struggle with data management, since their projects are not research, but quality improvement, and this book covers the subject well. I recommend it for DNP students for use during their capstone projects." Score: 98, 5 Stars --Doody's Medical Reviews This is the only text to deliver the strong data management knowledge and skills that are required competencies for all DNP students. It enables readers to design data tracking and clinical analytics in order to rigorously evaluate clinical innovations/programs for improving clinical outcomes, and to document and analyze change. The second edition is greatly expanded and updated to address major changes in our health care environment. Incorporating faculty and student input, it now includes modalities such as SPSS, Excel, and Tableau to address diverse data management tasks. Eleven new chapters cover the use of big data analytics, ongoing progress towards value-based payment, the ACA and its future, shifting of risk and accountability to hospitals and clinicians, advancement of nursing quality indicators, and new requirements for Magnet certification. The text takes the DNP student step by step through the complete process of data management from planning to presentation, and encompasses the scope of skills required for students to apply relevant analytics to systematically and confidently tackle the clinical interventions data obtained as part of the DNP student project. Of particular value is a progressive case study illustrating multiple techniques and methods throughout the chapters. Sample data sets and exercises, along with objectives, references, and examples in each chapter, reinforce information. Key Features: Provides extensive content for rigorously evaluating DNP innovations/projects Takes DNP students through the complete process of data management from planning through presentation Includes a progressive case study illustrating multiple techniques and methods Offers very specific examples of application and utility of techniques Delivers sample data sets, exercises, PowerPoint slides and more, compiled in Supplemental Materials and an Instructor Manual

Principles and Practice of Clinical Research

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Author :
Publisher : Elsevier
ISBN 13 : 9780080489568
Total Pages : 448 pages
Book Rating : 4.4/5 (895 download)

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Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government

Healthcare Data Analytics and Management

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Author :
Publisher : Academic Press
ISBN 13 : 0128156368
Total Pages : 340 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Healthcare Data Analytics and Management by : Nilanjan Dey

Download or read book Healthcare Data Analytics and Management written by Nilanjan Dey and published by Academic Press. This book was released on 2018-11-15 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare Data Analytics and Management help readers disseminate cutting-edge research that delivers insights into the analytic tools, opportunities, novel strategies, techniques and challenges for handling big data, data analytics and management in healthcare. As the rapidly expanding and heterogeneous nature of healthcare data poses challenges for big data analytics, this book targets researchers and bioengineers from areas of machine learning, data mining, data management, and healthcare providers, along with clinical researchers and physicians who are interested in the management and analysis of healthcare data. Covers data analysis, management and security concepts and tools in the healthcare domain Highlights electronic medical health records and patient information records Discusses the different techniques to integrate Big data and Internet-of-Things in healthcare, including machine learning and data mining Includes multidisciplinary contributions in relation to healthcare applications and challenges

Data Management and Analytics for Medicine and Healthcare

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Author :
Publisher : Springer
ISBN 13 : 9783319671857
Total Pages : 0 pages
Book Rating : 4.6/5 (718 download)

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Book Synopsis Data Management and Analytics for Medicine and Healthcare by : Edmon Begoli

Download or read book Data Management and Analytics for Medicine and Healthcare written by Edmon Begoli and published by Springer. This book was released on 2017-08-26 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the thoroughly refereed conference proceedings of the Third International Workshop on Data Management and Analytics for Medicine and Healthcare, DMAH 2017, in Munich, Germany, in September 2017, held in conjunction with the 43rd International Conference on Very Large Data Bases, VLDB 2017. The 9 revised full papers presented together with 2 keynote abstracts were carefully reviewed and selected from 16 initial submissions. The papers are organized in topical sections on data privacy and trustability for electronic health records; biomedical data management and Integration; online mining of Health related data; and clinical data analytics.

Clinical Research Computing

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Publisher : Academic Press
ISBN 13 : 012803145X
Total Pages : 240 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Clinical Research Computing by : Prakash Nadkarni

Download or read book Clinical Research Computing written by Prakash Nadkarni and published by Academic Press. This book was released on 2016-04-29 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Practical Guide to Clinical Data Management, Third Edition

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Author :
Publisher : CRC Press
ISBN 13 : 1439848297
Total Pages : 298 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Practical Guide to Clinical Data Management, Third Edition by : Susanne Prokscha

Download or read book Practical Guide to Clinical Data Management, Third Edition written by Susanne Prokscha and published by CRC Press. This book was released on 2011-10-26 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.

The Fundamentals of Clinical Research

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Publisher : John Wiley & Sons
ISBN 13 : 1118949595
Total Pages : 554 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis The Fundamentals of Clinical Research by : P. Michael Dubinsky

Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

A Clinical Trials Manual From The Duke Clinical Research Institute

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1444357883
Total Pages : 381 pages
Book Rating : 4.4/5 (443 download)

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Book Synopsis A Clinical Trials Manual From The Duke Clinical Research Institute by : Margaret Liu

Download or read book A Clinical Trials Manual From The Duke Clinical Research Institute written by Margaret Liu and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity." —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.

The Medical Library Association Guide to Data Management for Librarians

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Author :
Publisher : Rowman & Littlefield
ISBN 13 : 1442264284
Total Pages : 243 pages
Book Rating : 4.4/5 (422 download)

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Book Synopsis The Medical Library Association Guide to Data Management for Librarians by : Lisa Federer

Download or read book The Medical Library Association Guide to Data Management for Librarians written by Lisa Federer and published by Rowman & Littlefield. This book was released on 2016-09-15 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technological advances and the rise of collaborative, interdisciplinary approaches have changed the practice of research. The 21st century researcher not only faces the challenge of managing increasingly complex datasets, but also new data sharing requirements from funders and journals. Success in today’s research enterprise requires an understanding of how to work effectively with data, yet most researchers have never had any formal training in data management. Libraries have begun developing services and programs to help researchers meet the demands of the data-driven research enterprise, giving librarians exciting new opportunities to use their expertise and skills. The Medical Library Association Guide to Data Management for Librarians highlights the many ways that librarians are addressing researchers’ changing needs at a variety of institutions, including academic, hospital, and government libraries. Each chapter ends with “pearls of wisdom,” a bulleted list of 5-10 takeaway messages from the chapter that will help readers quickly put the ideas from the chapter into practice. From theoretical foundations to practical applications, this book provides a background for librarians who are new to data management as well as new ideas and approaches for experienced data librarians.

Validating Clinical Trial Data Reporting with SAS

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Author :
Publisher : SAS Institute
ISBN 13 : 1599941287
Total Pages : 229 pages
Book Rating : 4.5/5 (999 download)

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Book Synopsis Validating Clinical Trial Data Reporting with SAS by : Carol I. Matthews

Download or read book Validating Clinical Trial Data Reporting with SAS written by Carol I. Matthews and published by SAS Institute. This book was released on 2008 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration.