Compact Regs Parts 50 54 56 And 312
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Author | : Interpharm |
Publisher | : CRC Press |
Total Pages | : 241 |
Release | : 2013-10-23 |
Genre | : Medical |
ISBN | : 1482207982 |
This publication contains a verbatim reproduction of 21 CFR Part 50 Protection of Human Subjects, 21 CFR Part 54 Financial Disclosure by Clinical Investigators, 21 CFR Part 56 Institutional Review Boards & 21 CFR Part 312 Investigational New Drug Application.
Author | : Food and Drug Administration |
Publisher | : CRC Press |
Total Pages | : 184 |
Release | : 2002-09-30 |
Genre | : Medical |
ISBN | : 1135489734 |
The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources. They are the perfect low-cost tools for: employees as part of documented GMP training programs, for suppliers/vendors so
Author | : Interpharm |
Publisher | : CRC Press |
Total Pages | : 24 |
Release | : 2013-10-23 |
Genre | : Medical |
ISBN | : 9781482207989 |
This publication contains a verbatim reproduction of 21 CFR Part 50 Protection of Human Subjects, 21 CFR Part 54 Financial Disclosure by Clinical Investigators, 21 CFR Part 56 Institutional Review Boards & 21 CFR Part 312 Investigational New Drug Application.
Author | : Xingbin Yang |
Publisher | : Frontiers Media SA |
Total Pages | : 397 |
Release | : 2023-04-04 |
Genre | : Medical |
ISBN | : 2832519598 |
Author | : Adam E.M. Eltorai |
Publisher | : Elsevier |
Total Pages | : 770 |
Release | : 2023-03-22 |
Genre | : Science |
ISBN | : 0323906303 |
Translational Surgery covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully understand important concepts including case-control studies, prospective cohort studies, randomized trials, and reliability studies. Investigators will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in surgical research, and know what is needed for collaboration. Further, this title is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps the translational research navigate challenging considerations in study design and implementation. The book provides valuable discussions of the critical appraisal of published studies in surgery, allowing the reader to learn how to evaluate the quality of such studies. Thus, they will improve at measuring outcomes; making effective use of all types of evidence in patient care. In short, this practical guidebook will be of interest to every surgeon or surgical researcher who has ever had a good clinical idea, but not the knowledge of how to test it. - Focuses on translational research in Surgery, covering the principles of evidence-based medicine and applying those principles to the design of translational investigations - Provides a practical, straightforward approach to help surgeons and researchers navigate challenging aspects of study design and implementation - Details valuable discussions on the critical appraisal of published studies in Surgery, allowing the reader to effectively use all types of evidence for patient care
Author | : |
Publisher | : |
Total Pages | : 1360 |
Release | : 1946-03 |
Genre | : Administrative law |
ISBN | : |
Author | : Food and Drug Administration |
Publisher | : |
Total Pages | : 0 |
Release | : 2003 |
Genre | : Drugs |
ISBN | : 9780865879737 |
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 | : Agency for Healthcare Research and Quality/AHRQ |
Publisher | : Government Printing Office |
Total Pages | : 385 |
Release | : 2014-04-01 |
Genre | : Medical |
ISBN | : 1587634333 |
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.
Author | : |
Publisher | : |
Total Pages | : 606 |
Release | : 1993 |
Genre | : Administrative law |
ISBN | : |
Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.
Author | : United States. Employment Standards Administration. Wage and Hour Division |
Publisher | : |
Total Pages | : 20 |
Release | : 1984 |
Genre | : Collective labor agreements |
ISBN | : |