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Author : University of Minnesota. Office of Sponsored Programs
Publisher :
ISBN 13 :
Total Pages : 53 pages
Book Rating : 4.:/5 (194 download)
Download or read book Principal Investigator's Manual written by University of Minnesota. Office of Sponsored Programs and published by . This book was released on 1972 with total page 53 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : University of Florida. Institutional Review Board
Publisher :
ISBN 13 :
Total Pages : 44 pages
Book Rating : 4.:/5 (356 download)
Download or read book Principal Investigator's Manual written by University of Florida. Institutional Review Board and published by . This book was released on 1996 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Colorado State University. Office of Sponsored Research
Publisher :
ISBN 13 :
Total Pages : 46 pages
Book Rating : 4.:/5 (229 download)
Download or read book Procedures Manual for Principal Investigators written by Colorado State University. Office of Sponsored Research and published by . This book was released on 1973 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Food and Drug Administration
Publisher :
ISBN 13 : 9780865879737
Total Pages : 0 pages
Book Rating : 4.8/5 (797 download)
Download or read book FDA Investigations Operations Manual written by Food and Drug Administration and published by . This book was released on 2003 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Author : University of Utah
Publisher :
ISBN 13 :
Total Pages : 103 pages
Book Rating : 4.:/5 (114 download)
Download or read book Principal Investigator's Handbook written by University of Utah and published by . This book was released on 1984 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ruth Jennifer Cavalieri
Publisher : Nursing Knowledge International
ISBN 13 : 9781937554644
Total Pages : 262 pages
Book Rating : 4.5/5 (546 download)
Download or read book Clinical Research Manual written by Ruth Jennifer Cavalieri and published by Nursing Knowledge International. This book was released on 2013 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Margaret Liu
Publisher : John Wiley & Sons
ISBN 13 : 1444357883
Total Pages : 381 pages
Book Rating : 4.4/5 (443 download)
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.
Author : Yale University. Office of the Provost
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (966 download)
Download or read book Principal Investigator's Guide written by Yale University. Office of the Provost and published by . This book was released on 1989 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : National Cancer Institute (U.S.)
Publisher :
ISBN 13 :
Total Pages : 40 pages
Book Rating : 4.:/5 (318 download)
Download or read book Guide to the Principal Investigator of NCI Contracts written by National Cancer Institute (U.S.) and published by . This book was released on 1987 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Smithsonian Institution. Office of Sponsored Projects
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (52 download)
Download or read book Principal Investigators Guide written by Smithsonian Institution. Office of Sponsored Projects and published by . This book was released on 1993 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Harvard University. Office for Sponsored Research
Publisher :
ISBN 13 :
Total Pages : 51 pages
Book Rating : 4.:/5 (32 download)
Download or read book Guide for Sponsored Project Administrators written by Harvard University. Office for Sponsored Research and published by . This book was released on 1993 with total page 51 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Smithsonian Institution
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (434 download)
Download or read book Principal Investigators Guide written by Smithsonian Institution and published by . This book was released on 1999 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Phyllis G. Supino
Publisher : Springer Science & Business Media
ISBN 13 : 1461433606
Total Pages : 286 pages
Book Rating : 4.4/5 (614 download)
Download or read book Principles of Research Methodology written by Phyllis G. Supino and published by Springer Science & Business Media. This book was released on 2012-06-22 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Research Methodology: A Guide for Clinical Investigators is the definitive, comprehensive guide to understanding and performing clinical research. Designed for medical students, physicians, basic scientists involved in translational research, and other health professionals, this indispensable reference also addresses the unique challenges and demands of clinical research and offers clear guidance in becoming a more successful member of a medical research team and critical reader of the medical research literature. The book covers the entire research process, beginning with the conception of the research problem to publication of findings. Principles of Research Methodology: A Guide for Clinical Investigators comprehensively and concisely presents concepts in a manner that is relevant and engaging to read. The text combines theory and practical application to familiarize the reader with the logic of research design and hypothesis construction, the importance of research planning, the ethical basis of human subjects research, the basics of writing a clinical research protocol and scientific paper, the logic and techniques of data generation and management, and the fundamentals and implications of various sampling techniques and alternative statistical methodologies. Organized in thirteen easy to read chapters, the text emphasizes the importance of clearly-defined research questions and well-constructed hypothesis (reinforced throughout the various chapters) for informing methods and in guiding data interpretation. Written by prominent medical scientists and methodologists who have extensive personal experience in biomedical investigation and in teaching key aspects of research methodology to medical students, physicians and other health professionals, the authors expertly integrate theory with examples and employ language that is clear and useful for a general medical audience. A major contribution to the methodology literature, Principles of Research Methodology: A Guide for Clinical Investigators is an authoritative resource for all individuals who perform research, plan to perform it, or wish to understand it better.
Author : National Learning Corporation
Publisher :
ISBN 13 : 9781731817914
Total Pages : 156 pages
Book Rating : 4.8/5 (179 download)
Download or read book Principal Investigator written by National Learning Corporation and published by . This book was released on 2020-10-20 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Principal Investigator Passbook(R) prepares you for your test by allowing you to take practice exams in the subjects you need to study. It provides hundreds of questions and answers in the areas that will likely be covered on your upcoming exam.
Author : JoAnn Pfeiffer
Publisher : CRC Press
ISBN 13 : 1315299771
Total Pages : 292 pages
Book Rating : 4.3/5 (152 download)
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :
Publisher : Asis International
ISBN 13 : 9781934904022
Total Pages : 332 pages
Book Rating : 4.9/5 (4 download)
Download or read book Professional Investigator's Manual written by and published by Asis International. This book was released on 2010-01-01 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : University of New Mexico. Office of the Associate Provost for Research
Publisher :
ISBN 13 :
Total Pages : 58 pages
Book Rating : 4.:/5 (167 download)
Download or read book Guide for Principal Investigators written by University of New Mexico. Office of the Associate Provost for Research and published by . This book was released on 1985 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt:
