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 Assuring Product Integrity written by Eugene R. Carrubba and published by . This book was released on 1975 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Assuring quality and accountability in postsecondary education written by United States. Congress. House. Committee on Education and the Workforce. Subcommittee on 21st Century Competitiveness and published by . This book was released on 2002 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Assuring Quality and Integrity written by United States. Legislature. Assembly. Commission on Occupational Education Institutions and published by . This book was released on 1994 with total page 10 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ensuring the Integrity of Electronic Health Records written by Orlando López and published by CRC Press. This book was released on 2020-12-21 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.
Download or read book Handbook of Academic Integrity written by Sarah Elaine Eaton and published by Springer Nature. This book was released on 2023-12-04 with total page 1924 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book brings together diverse views from around the world and provides a comprehensive overview of academic integrity and how to create the ethical academy. At the same time, the Handbook does not shy away from some of the vigorous debates in the field such as the causes of academic integrity breaches. There has been an explosion of interest in academic integrity in the last 20-30 years. New technologies that have made it easier than ever for students to ‘cut and paste’, coupled with global media scandals of high profile researchers behaving badly, have resulted in the perception that plagiarism is ‘on the rise’. This, in combination with the massification and commercialisation of higher education, has resulted in a burgeoning interest in the importance of academic integrity, how to safeguard it and how to address breaches appropriately. What may have seemed like a relatively easy topic to address – students copying sources without attribution – has in fact, turned out to be a complex, interdisciplinary field of research requiring contributions from linguists, psychologists, social scientists, anthropologists, teaching and learning specialists, mathematicians, accountants, medical doctors, lawyers and philosophers, to name just a few. Because of this broad interest and input, this handbook serves as the single authoritative reference work which brings together the vast, growing, interdisciplinary and at times contradictory body of literature. For both established researchers/practitioners and those new to the field, this Handbook provides a one-stop-shop as well as a launching pad for new explorations and discussions.
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 396 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 Data Integrity and Quality written by Santhosh Kumar Balan and published by BoD – Books on Demand. This book was released on 2021-06-23 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is the quality, reliability, trustworthiness, and completeness of a data set, providing accuracy, consistency, and context. Data quality refers to the state of qualitative or quantitative pieces of information. Over five sections, this book discusses data integrity and data quality as well as their applications in various fields.
Download or read book Fundamentals of Environmental Assessment written by Glenn W. Suter II and published by CRC Press. This book was released on 2023-06-14 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: 1. Integrates human health and ecological assessments. 2. Includes epidemiological, risk, causal, impact, and outcome assessments. 3. Focuses on fundamental principles that are applicable in all nations and legal contexts. 4. Employs an engaging style and draws on the author’s practical experience. 5. Explains fundamental concepts in short chapters, making it perfect for beginners in the field. 6. Explains the challenges and rewards of a career in environmental assessment.
Download or read book Policy written by G. Bruce Doern and published by McGill-Queen's Press - MQUP. This book was released on 2010 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essays in honour of one of Canada's finest scholars of public policy.
Download or read book Students and universities written by Great Britain: Parliament: House of Commons: Innovation, Universities, Science and Skills Committee and published by The Stationery Office. This book was released on 2009-08-02 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incorporating HC 370
Download or read book Federal Register written by and published by . This book was released on 1978 with total page 1186 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Code of Federal Regulations written by and published by . This book was released on 2002 with total page 662 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ensuring the Integrity Accessibility and Stewardship of Research Data in the Digital Age written by Institute of Medicine and published by National Academies Press. This book was released on 2009-11-17 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: As digital technologies are expanding the power and reach of research, they are also raising complex issues. These include complications in ensuring the validity of research data; standards that do not keep pace with the high rate of innovation; restrictions on data sharing that reduce the ability of researchers to verify results and build on previous research; and huge increases in the amount of data being generated, creating severe challenges in preserving that data for long-term use. Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age examines the consequences of the changes affecting research data with respect to three issues - integrity, accessibility, and stewardship-and finds a need for a new approach to the design and the management of research projects. The report recommends that all researchers receive appropriate training in the management of research data, and calls on researchers to make all research data, methods, and other information underlying results publicly accessible in a timely manner. The book also sees the stewardship of research data as a critical long-term task for the research enterprise and its stakeholders. Individual researchers, research institutions, research sponsors, professional societies, and journals involved in scientific, engineering, and medical research will find this book an essential guide to the principles affecting research data in the digital age.
Download or read book Maintaining the Integrity of Scientific Research written by United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Investigations and Oversight and published by . This book was released on 1990 with total page 1468 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Program Plan written by United States. Food Safety and Inspection Service and published by . This book was released on 1983 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Hearings written by United States. Congress. House and published by . This book was released on 1951 with total page 2546 pages. Available in PDF, EPUB and Kindle. Book excerpt:
