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 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 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. Features: Provides an introduction and background information for the spectrum of clinical data management tasks. Outstanding text in the industry and has been used by the Society for Clinical Data Management in creating its certification exam. Explains the high-level flow of a clinical trial from creation of the protocol through study lock. Reflects electronic data capture and interactive response technologies. Discusses using the concept of three phases in the clinical data management of a study: study startup, study conduct, and study closeout, to write procedures and train staff.

This book discusses managing SOPs for 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 focused on the practical aspects of SOPs and SOP management.

The Ebola Virus and West Africa: Medical and Sociocultural Aspects provides a compact summary of the Ebola virus, outlining its nature, history, epidemiology, and methods of treatment. In addition, the work examines the context of the diseases outbreak by describing the people, politics, and policies in West Africa before, during, and after the recent outbreak. Finally, chapters summarize and explore the ethical issues that arise in pursuing treatments and discuss methods for improving control and prevention of additional outbreaks. Dr. Felix I. Ikuomola, a medical doctor who is pursuing additional advanced degrees in clinical research (UH) and surgical sciences (RCSEd/Edin), brings to bear his practice of medicine and surgery in Liberia, Nigeria, Sierra Leone, and the Gambia and his direct knowledge of the cultural practices and factors at play in the countries of West Africa to ground the presentation in The Ebola Virus and West Africa in the realities of the current situation in the region. The Ebola Virus and West Africa: Medical and Sociocultural Aspects will provide a highly organized, comprehensive, and insightful treatment of this virulent disease and its sociocultural elements to people with medical backgrounds and to individuals desiring to understand more comprehensively the impact of this disease on West Africa. In either case, time spent with The Ebola Virus and West Africa will give you the background and analysis you need to respond intelligently to the challenges the virus presents to an increasingly globalized culture.

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.

New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.

Health informatics is the discipline concerned with the management of healthcare data and information through the application of computers and other information technologies. The field focuses more on identifying and applying information in the healthcare field and less on the technology involved. Our goal is to stimulate and educate healthcare and IT professionals and students about the key topics in this rapidly changing field. This seventh edition reflects the current knowledge in the topics listed below and provides learning objectives, key points, case studies and extensive references. Available as a paperback and eBook. Visit the textbook companion website at http://informaticseducation.org for more information.--Page 4 de la couverture.

Comprehensive in scope, this totally revamped edition of a bestseller is the ideal desk reference for anyone tasked with hazard control and safety management in the healthcare industry. Presented in an easy-to-read format, Healthcare Hazard Control and Safety Management, Third Edition examines hazard control and safety management as proactive functions of an organization. Like its popular predecessors, the book supplies a complete overview of hazard control, safety management, compliance, standards, and accreditation in the healthcare industry. This edition includes new information on leadership, performance improvement, risk management, organizational culture, behavioral safety, root cause analysis, and recent OSHA and Joint Commission Emergency Management requirements and regulatory changes. The book illustrates valuable insights and lessons learned by author James T. Tweedy, executive director of the International Board for Certification of Safety Managers. In the text, Mr. Tweedy touches on the key concepts related to safety management that all healthcare leaders need to understand. Identifies common factors that are often precursors to accidents in the healthcare industry Examines the latest OSHA and Joint Commission Emergency Management Requirements and Standards Covers facility safety, patient safety, hazardous substance safety, imaging and radiation safety, infection control and prevention, and fire safety management Includes references to helpful information from federal agencies, standards organizations, and voluntary associations Outlining a proactive hazard control approach based on leadership involvement, the book identifies the organizational factors that support accident prevention. It also examines organizational dynamics and supplies tips for improving organizational knowledge management. Complete with accompanying checklists and sample management plans that readers can immediately put to use, this text is currently the primary study reference for the Certified Healthcare Safety Professional Examination.

This comprehensive resource provides on-the-job training for statistical programmers who use SAS in the pharmaceutical industry This one-stop resource offers a complete review of what entry- to intermediate-level statistical programmers need to know in order to help with the analysis and reporting of clinical trial data in the pharmaceutical industry. SAS Programming in the Pharmaceutical Industry, Second Edition begins with an introduction to the pharmaceutical industry and the work environment of a statistical programmer. Then it gives a chronological explanation of what you need to know to do the job. It includes information on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. This edition has been updated for SAS 9.4, and it features new graphics as well as all new examples using CDISC SDTM or ADaM model data structures. Whether you're a novice seeking an introduction to SAS programming in the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, this real-world reference guide offers a wealth of practical suggestions to help you sharpen your skills. This book is part of the SAS Press program.