Download or read book 52 Experiments with Regulatory Review The Political and Economic Inputs Into State Rulemakings written by Jason A Schwartz and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Download or read book Government Auditing Standards 2018 Revision written by United States Government Accountability Office and published by Lulu.com. This book was released on 2019-03-24 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Audits provide essential accountability and transparency over government programs. Given the current challenges facing governments and their programs, the oversight provided through auditing is more critical than ever. Government auditing provides the objective analysis and information needed to make the decisions necessary to help create a better future. The professional standards presented in this 2018 revision of Government Auditing Standards (known as the Yellow Book) provide a framework for performing high-quality audit work with competence, integrity, objectivity, and independence to provide accountability and to help improve government operations and services. These standards, commonly referred to as generally accepted government auditing standards (GAGAS), provide the foundation for government auditors to lead by example in the areas of independence, transparency, accountability, and quality through the audit process. This revision contains major changes from, and supersedes, the 2011 revision.
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.
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Standards for Internal Control in the Federal Government written by United States Government Accountability Office and published by Lulu.com. This book was released on 2019-03-24 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: Policymakers and program managers are continually seeking ways to improve accountability in achieving an entity's mission. A key factor in improving accountability in achieving an entity's mission is to implement an effective internal control system. An effective internal control system helps an entity adapt to shifting environments, evolving demands, changing risks, and new priorities. As programs change and entities strive to improve operational processes and implement new technology, management continually evaluates its internal control system so that it is effective and updated when necessary. Section 3512 (c) and (d) of Title 31 of the United States Code (commonly known as the Federal Managers' Financial Integrity Act (FMFIA)) requires the Comptroller General to issue standards for internal control in the federal government.
Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Download or read book Models in Environmental Regulatory Decision Making written by National Research Council and published by National Academies Press. This book was released on 2007-08-25 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many regulations issued by the U.S. Environmental Protection Agency (EPA) are based on the results of computer models. Models help EPA explain environmental phenomena in settings where direct observations are limited or unavailable, and anticipate the effects of agency policies on the environment, human health and the economy. Given the critical role played by models, the EPA asked the National Research Council to assess scientific issues related to the agency's selection and use of models in its decisions. The book recommends a series of guidelines and principles for improving agency models and decision-making processes. The centerpiece of the book's recommended vision is a life-cycle approach to model evaluation which includes peer review, corroboration of results, and other activities. This will enhance the agency's ability to respond to requirements from a 2001 law on information quality and improve policy development and implementation.
Download or read book Impact Evaluation in Practice Second Edition written by Paul J. Gertler and published by World Bank Publications. This book was released on 2016-09-12 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of the Impact Evaluation in Practice handbook is a comprehensive and accessible introduction to impact evaluation for policy makers and development practitioners. First published in 2011, it has been used widely across the development and academic communities. The book incorporates real-world examples to present practical guidelines for designing and implementing impact evaluations. Readers will gain an understanding of impact evaluations and the best ways to use them to design evidence-based policies and programs. The updated version covers the newest techniques for evaluating programs and includes state-of-the-art implementation advice, as well as an expanded set of examples and case studies that draw on recent development challenges. It also includes new material on research ethics and partnerships to conduct impact evaluation. The handbook is divided into four sections: Part One discusses what to evaluate and why; Part Two presents the main impact evaluation methods; Part Three addresses how to manage impact evaluations; Part Four reviews impact evaluation sampling and data collection. Case studies illustrate different applications of impact evaluations. The book links to complementary instructional material available online, including an applied case as well as questions and answers. The updated second edition will be a valuable resource for the international development community, universities, and policy makers looking to build better evidence around what works in development.
Download or read book Inspector General Reform Act of 2008 written by United States and published by . This book was released on 2008 with total page 2 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Improving the Regulatory Review Process written by C. Lumley and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.
Download or read book Measuring Regulatory Performance A Practitioner s Guide to Perception Surveys written by OECD and published by OECD Publishing. This book was released on 2012-01-16 with total page 91 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide helps officials use perception surveys for evaluating and communicating progress in regulatory reform. It explains the challenges involved in the design and use of business and citizen perception surveys – and ways to overcome them.
Download or read book Federal Contract Compliance Manual written by United States. Office of Federal Contract Compliance Programs and published by . This book was released on 1990 with total page 1110 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book United States Attorneys Manual written by United States. Department of Justice and published by . This book was released on 1985 with total page 720 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Vision 2000 written by and published by . This book was released on 1999 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Evaluation of Guidelines for Exposures to Technologically Enhanced Naturally Occurring Radioactive Materials written by National Research Council and published by National Academies Press. This book was released on 1999-02-25 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: Naturally occurring radionuclides are found throughout the earth's crust, and they form part of the natural background of radiation to which all humans are exposed. Many human activities-such as mining and milling of ores, extraction of petroleum products, use of groundwater for domestic purposes, and living in houses-alter the natural background of radiation either by moving naturally occurring radionuclides from inaccessible locations to locations where humans are present or by concentrating the radionuclides in the exposure environment. Such alterations of the natural environment can increase, sometimes substantially, radiation exposures of the public. Exposures of the public to naturally occurring radioactive materials (NORM) that result from human activities that alter the natural environment can be subjected to regulatory control, at least to some degree. The regulation of public exposures to such technologically enhanced naturally occurring radioactive materials (TENORM) by the US Environmental Protection Agency (EPA) and other regulatory and advisory organizations is the subject of this study by the National Research Council's Committee on the Evaluation of EPA Guidelines for Exposures to Naturally Occurring Radioactive Materials.
Download or read book Federal Evaluations written by and published by . This book was released on with total page 800 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains an inventory of evaluation reports produced by and for selected Federal agencies, including GAO evaluation reports that relate to the programs of those agencies.
