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Practical Guide to Clinical Data Management, Third Edition
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 creat...
Practical Guide to Clinical Data Management
The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers. Featur...
Writing and Managing SOPs for GCP
Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focus
Practical Guide to Clinical Data Management, Second Edition
The management of clinical data, from its collection 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. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today. Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling. Updates to the Second Edition...
Pursuing Excellence in Healthcare
Much as it is with the nation‘s overall healthcare system, the survival of academic medical centers (AMC‘s) is threatened by a combination of economic, cultural, and demographic factors. If AMC‘s are to survive to fill their societal responsibilities, they must adopt a new philosophy. Challenging assumptions and providing the shift in perspective t
Ethical and Regulatory Aspects of Clinical Research
Professionals in need of such training and bioethicists will be interested.
A Clinical Trials Manual From The Duke Clinical Research Institute
"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 Cl...
The Healthcare Professional's Guide to Clinical Cultural Competence
With a focus on client-centred care, this book provides an introduction to developing cultural competence in the health care setting. A unique presentation covering both theory and practice, the book begins with a strong foundational model for understanding culture. It then introduces general knowledge on culture which can be provided to a variety of settings, and ends with clinical applications illustrating how to apply knowledge and awareness to a variety of populations. With contributions from twelve leading experts, material is drawn from a wide range of health care settings and has strong practical coverage throughout. Unique approach: looks at populations the way health care workers encounter them, not by ethno-cultural/religious labels Multidisciplinary approach to writing reflects a variety of perspectives and direct front-line experience Discussion is broad and inclusive, integrating different perspectives, but also makes visible the different paradigms used to approach the topic Case studies and questions encourage critical thinking and dialogue
Practical Guide to Clinical Data Management
The management of clinical data, from its collection 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. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s t
