The CRA's Guide to Monitoring Clinical Research PDF Download
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Author: Karen E. Woodin
Publisher: CenterWatch
ISBN: 9781930624375
Category : Medical
Languages : en
Pages : 448
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Book Description
Author: Karen E. Woodin
Publisher: CenterWatch
ISBN: 9781930624375
Category : Medical
Languages : en
Pages : 448
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Book Description
Author: William F. Salminen
Publisher: Academic Press
ISBN: 0123978319
Category : Technology & Engineering
Languages : en
Pages : 263
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Book Description
Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny. - Includes both the "big picture" look at complex processes, such as contracting toxicology and safety studies with CROs, as well as a detailed account of each individual step - Contains several real world examples of problems in preclinical studies to provide you with an idea of the types of challenges that are routinely encountered and how this book can help you avoid these issues - Provides monitoring checklists through the book that will help you comply with each GLP requirement and maintain compliance throughout the entire process - Both entry level and experienced scientists involved in nonclinical toxicology study monitoring will benefit from the ideas, examples, discussions and strategies presented throughout this book
Author: David W. Lime
Publisher:
ISBN:
Category : National parks and reserves
Languages : en
Pages : 204
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Book Description
Author: Sada H. Shah
Publisher: Taylor & Francis
ISBN: 1040093671
Category : Psychology
Languages : en
Pages : 211
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Book Description
Monitoring and Evaluation of Practice and Methods in Applied Social Research is a comprehensive guide delving into the core concepts, tools, methods, and approaches of monitoring and evaluation (M&E). This book reveals the roots of M&E, illustrating its evolution from academia into a burgeoning field of science across various contexts. The challenge practitioners face lies in the inconsistent terminology used for identical concepts among humanitarian organizations, hindering the growth of M&E through shared learning. Embracing an abductive approach, this book seeks to establish M&E as distinct fields within social research. In doing so, it bridges the philosophical gap between novice and expert social researchers and provides a consolidated resource based on real-world experiences. Written by an expert with over a decade of hands-on experience in applied social research, this book serves as an invaluable tool, offering insights into the diverse landscape of M&E, enabling students and practitioners to navigate various contexts with ease. Nongovernmental organizations (NGOs), United Nations (UN) bodies, and organizations involved in M&E will also find this book instrumental, creating a bridge of standardized concepts, nomenclature, and approaches.
Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 70
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Book Description
Author: Tamim M. Younos
Publisher: Water Resources Publication
ISBN: 9781887201339
Category : Technology & Engineering
Languages : en
Pages : 248
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Book Description
The book provides an overview of the 21st century water monitoring technologies and their potential for water quality-protection. This book is best suitable as a reference for water monitoring agencies and graduate studies in water monitoring research.
Author: John I. Gallin
Publisher: Elsevier
ISBN: 0080489567
Category : Science
Languages : en
Pages : 447
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Book Description
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
Author: Michael J. Paul
Publisher: Morgan & Claypool Publishers
ISBN: 1681730960
Category : Computers
Languages : en
Pages : 185
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Book Description
Public health thrives on high-quality evidence, yet acquiring meaningful data on a population remains a central challenge of public health research and practice. Social monitoring, the analysis of social media and other user-generated web data, has brought advances in the way we leverage population data to understand health. Social media offers advantages over traditional data sources, including real-time data availability, ease of access, and reduced cost. Social media allows us to ask, and answer, questions we never thought possible. This book presents an overview of the progress on uses of social monitoring to study public health over the past decade. We explain available data sources, common methods, and survey research on social monitoring in a wide range of public health areas. Our examples come from topics such as disease surveillance, behavioral medicine, and mental health, among others. We explore the limitations and concerns of these methods. Our survey of this exciting new field of data-driven research lays out future research directions.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309084881
Category : Medical
Languages : en
Pages : 313
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Book Description
When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.
Author: A A Van Dooren
Publisher: World Scientific
ISBN: 9813223197
Category : Medical
Languages : en
Pages : 535
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Book Description
Clinical research monitoring is a vital aspect of Good Clinical Practice (GCP). Its principles are straightforward: they are aimed at protecting those subjects that participate in the trial, and their goal is to provide reliable data that will contribute to the safety and efficacy of the intervention under study, i.e. to support the health of future subjects. However, the practical implementation of these major goals is complicated. Various mishaps have happened in recent history, and an extensive set of international rules and regulations have emerged.This book gives a thorough survey of the ethical and legal aspects of clinical research and provides a detailed guideline for implementing these aspects into the practice of studying investigational medicinal products in humans, in the European context. It can be used as a study aid for starting monitors, a reference guide for more experienced monitors, and anyone else involved in clinical research.Related Link(s)
