Annual Report, Research and Investigational Activities

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ISBN 13 :
Total Pages : 428 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Annual Report, Research and Investigational Activities by : University of Georgia. College of Agriculture

Download or read book Annual Report, Research and Investigational Activities written by University of Georgia. College of Agriculture and published by . This book was released on 1945 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Progress Report...research and Investigational Activities in Agricultural Engineering

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Publisher :
ISBN 13 :
Total Pages : 64 pages
Book Rating : 4.3/5 (243 download)

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Book Synopsis Progress Report...research and Investigational Activities in Agricultural Engineering by : Virginia Polytechnic Institute and State University. Department of Agricultural Engineering

Download or read book Progress Report...research and Investigational Activities in Agricultural Engineering written by Virginia Polytechnic Institute and State University. Department of Agricultural Engineering and published by . This book was released on 1939 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Registries for Evaluating Patient Outcomes

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Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Ethical Conduct of Clinical Research Involving Children

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Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Clinical Investigation Program Annual Progress Report

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Publisher :
ISBN 13 :
Total Pages : 316 pages
Book Rating : 4.:/5 (227 download)

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Book Synopsis Clinical Investigation Program Annual Progress Report by : Donald G. Corby

Download or read book Clinical Investigation Program Annual Progress Report written by Donald G. Corby and published by . This book was released on 1985 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: Subject report identifies the research activities conducted by Fitzsimons Army Medical Center investigators through protocols approved by the Institutional Review Committee and registered with the Department of Clinical Investigation during Fiscal Year 1986 and other known presentations and publications by the Fitzsimons Army Medical Center professional staff. The research protocols described were conducted under the provisions of AR 40-38, as amended, Clinical Investigation Program, AR 40-7, Use of Investigational Drugs in Humans, AR 70-25, HSC Rev 40-23, as amended, Management of Clinical Investigation Protocols and Reports, Use of Volunteers as Subjects of Research and AR 40-38, as amended, Department of Clinical Investigation, Policies and Procedures, to insure the medical well-being, preservation of rights and dignity of human subjects who participated in these investigations.

Sharing Clinical Trial Data

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Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 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 236 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.

Beyond the HIPAA Privacy Rule

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Publisher : National Academies Press
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

A Clinical Trials Manual From The Duke Clinical Research Institute

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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.

Clinical Investigation Program. Annual Progress Report

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ISBN 13 :
Total Pages : 251 pages
Book Rating : 4.:/5 (227 download)

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Book Synopsis Clinical Investigation Program. Annual Progress Report by : H. Linton

Download or read book Clinical Investigation Program. Annual Progress Report written by H. Linton and published by . This book was released on 1994 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report identifies approved clinical research activities conducted at Walter Reed Army Medical Center through protocols approved by the Clinical Investigation Committee, the Human Use Committee/Institutional Review Board, and/or the Animal Use Committee, as appropriate. This report includes a Detail Summary Sheet outlining the progress of each protocol during Fiscal Year 93. Also included is a list of all known presentations and publications related to approved studies, as well as those not related to approved clinical investigation protocols. All research was conducted under the provisions of AR 40-38 (Clinical Investigation Program), AR 40-7 (Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Drug Substances), AR 70-25 (Use of Volunteers as Subjects of Research), HSC Reg 40-23 (Management of Clinical Investigations, Protocols, and Reports), and AR 70-18 (The Use of Animals in DOD Programs).

Annual Report of the Chief of Engineers on Civil Works Activities

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Publisher :
ISBN 13 :
Total Pages : 1394 pages
Book Rating : 4.3/5 (129 download)

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Book Synopsis Annual Report of the Chief of Engineers on Civil Works Activities by : United States. Army. Corps of Engineers. Civil Works Directorate

Download or read book Annual Report of the Chief of Engineers on Civil Works Activities written by United States. Army. Corps of Engineers. Civil Works Directorate and published by . This book was released on with total page 1394 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Report on Activities Under the National Traffic and Motor Vehicle Safety Act of 1966

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Publisher :
ISBN 13 :
Total Pages : 160 pages
Book Rating : 4.3/5 (243 download)

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Book Synopsis Report on Activities Under the National Traffic and Motor Vehicle Safety Act of 1966 by :

Download or read book Report on Activities Under the National Traffic and Motor Vehicle Safety Act of 1966 written by and published by . This book was released on 1971 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Safety; a Report on Activities Under the National Traffic and Motor Vehicle Safety Act

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Publisher :
ISBN 13 :
Total Pages : 348 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Safety; a Report on Activities Under the National Traffic and Motor Vehicle Safety Act by : United States. National Highway Traffic Safety Administration

Download or read book Safety; a Report on Activities Under the National Traffic and Motor Vehicle Safety Act written by United States. National Highway Traffic Safety Administration and published by . This book was released on with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Report

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Publisher :
ISBN 13 :
Total Pages : 1198 pages
Book Rating : 4.E/5 ( download)

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Book Synopsis Report by : University of California (System). College of Agriculture

Download or read book Report written by University of California (System). College of Agriculture and published by . This book was released on 1918 with total page 1198 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Responsible Research

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Publisher : National Academies Press
ISBN 13 : 0309084881
Total Pages : 313 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Responsible Research by : Institute of Medicine

Download or read book Responsible Research written by Institute of Medicine and published by National Academies Press. This book was released on 2003-02-06 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Nature sketch

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Publisher :
ISBN 13 :
Total Pages : 14 pages
Book Rating : 4.:/5 (696 download)

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Book Synopsis Nature sketch by :

Download or read book Nature sketch written by and published by . This book was released on 18?? with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Report on Activities Under the National Traffic & Motor Vehicle Safety Act

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Publisher :
ISBN 13 :
Total Pages : 496 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Report on Activities Under the National Traffic & Motor Vehicle Safety Act by : United States. National Highway Traffic Safety Administration

Download or read book Report on Activities Under the National Traffic & Motor Vehicle Safety Act written by United States. National Highway Traffic Safety Administration and published by . This book was released on 1970 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Prevention and Treatment of Missing Data in Clinical Trials

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Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council

Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.