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Author : Karen E. Woodin,John C. Schneider
Publisher : CenterWatch
Page : 448 pages
File Size : 48,5 Mb
Release : 2003-01-01
Category : Medical
ISBN : 1930624379
Author : David L. DeMets,Curt D. Furberg,Lawrence M. Friedman
Publisher : Springer Science & Business Media
Page : 389 pages
File Size : 40,7 Mb
Release : 2006-06-22
Category : Medical
ISBN : 9780387301075
From the authors of "Fundamentals of Clinical Trials" which has sold over 15,000 copies world wide since its publication in 1998. No competition yet as the text does not focus on how to do clinical trials but on very specific situations that can be encountered during the process.
Author : Susan S. Ellenberg,Thomas R. Fleming,David L. DeMets
Publisher : John Wiley & Sons
Page : 208 pages
File Size : 43,9 Mb
Release : 2003-01-17
Category : Mathematics
ISBN : 9780470854150
There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. * Provides a practical overview of data monitoring in clinical trials. * Describes the purpose, responsibilities and operation of data monitoring committees. * Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. * Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. * Discusses issues pertinent to those working in clinical trials in both the US and Europe. The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.
Author : William Clarke,Amitava Dasgupta
Publisher : Elsevier
Page : 376 pages
File Size : 41,9 Mb
Release : 2016-07-21
Category : Medical
ISBN : 9780128020524
Clinical Challenges in Therapeutic Drug Monitoring: Special Populations, Physiological Conditions and Pharmacogenomics focuses on critical issues in therapeutic drug monitoring including special requirements of therapeutic drug monitoring important to special populations (infants and children, pregnant women, elderly patients, and obese patients). The book also covers issues of free drug monitoring and common interferences in using immunoassays for therapeutic drug monitoring. This book is essential reading for any clinician, fellow, or trainee who wants to gain greater insight into the process of therapeutic drug monitoring for individual dosage adjustment and avoiding drug toxicity for certain drugs within a narrow therapeutic window. The book is written specifically for busy clinicians, fellows, and trainees who order therapeutic drug monitoring and need to get more familiar with testing methodologies, issues of interferences, and interpretation of results in certain patient populations. Offers busy clinicians, pathologists, and trainees a concise resource on the key aspects and critical issues in therapeutic drug monitoring Focuses on patient populations such as infants and children, pregnant women, elderly patients, and obese patients, who have special requirements in therapeutic drug monitoring Explores special topics in therapeutic drug monitoring including free drug monitoring and common immunoassay interference Explains how individual dosage adjustments can prevent drug toxicity for certain drugs within a narrow therapeutic window
Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
Page : 396 pages
File Size : 42,5 Mb
Release : 2014-04-01
Category : Medical
ISBN : 9781587634338
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 : World Health Organization
Publisher : Unknown
Page : 0 pages
File Size : 41,8 Mb
Release : 2022
Category : Electronic
ISBN : OCLC:1396937430
Author : Paul P. Glasziou,Les Irwig,Jeffrey K. Aronson
Publisher : John Wiley & Sons
Page : 376 pages
File Size : 47,8 Mb
Release : 2008-04-30
Category : Medical
ISBN : 9780470695616
Monitoring is a major component of management of chronic diseases such as diabetes, cardiovascular disease, arthritis and depression. Yet poor monitoring means healthcare costs are rising. This book discusses how monitoring principles adopted in other spheres such as clinical pharmacology and evidence-based medicine can be applied to chronic disease in the global setting. With contributions from leading experts in evidence-based medicine, it is a ground-breaking text for all involved in delivery of better and more effective management of chronic illnesses.
Author : OECD,World Health Organization
Publisher : OECD Publishing
Page : 128 pages
File Size : 45,5 Mb
Release : 2019-10-17
Category : Electronic
ISBN : 9789264805903
This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Author : Van Dooren A A
Publisher : World Scientific
Page : 536 pages
File Size : 41,5 Mb
Release : 2017-09-21
Category : Medical
ISBN : 9789813223196
Clinical research monitoring is a vital aspect of Good Clinical Practice (GCP). Its principles are straightforward: they are aimed at protecting those subjects that participate in the trial, and their goal is to provide reliable data that will contribute to the safety and efficacy of the intervention under study, i.e. to support the health of future subjects. However, the practical implementation of these major goals is complicated. Various mishaps have happened in recent history, and an extensive set of international rules and regulations have emerged. This book gives a thorough survey of the ethical and legal aspects of clinical research and provides a detailed guideline for implementing these aspects into the practice of studying investigational medicinal products in humans, in the European context. It can be used as a study aid for starting monitors, a reference guide for more experienced monitors, and anyone else involved in clinical research. Contents: The PastMedicinal Products: The Development ProcessClinical Trials: Design AspectsThe Rules and the RegsThe Ethical Pillars of Clinical ResearchThe Players Part I: Ethics Committee and Data Monitoring CommitteeThe Players Part II: The Sponsor and the Clinical Research OrganisationThe Players Part III: The Investigator, the Sub-Investigator and the Clinical Research CoordinatorThe Players Part IV: The Pharmacy and the Clinical LaboratoryThe Players Part V: The Subject or PatientSafety Assessment and MonitoringThe VisitsThe Essential Documents Part I: Before Study StartThe Essential Documents Part II: During Trial ConductThe Essential Documents Part III: After Completion or Termination of the TrialData ManagementA Special Case: Medical DevicesComplianceThe Challenge of MonitoringThe Future of Clinical Trial Monitoring — Some Afterthoughts Readership: Clinical research monitors, clinical research associates, trial monitors, clinical research sponsors, contract research organizations (CROs), ethics committees, clinical investigators, and study nurses. Keywords: Clinical Research;Monitoring;CRA;GCP;Clinical Trials;Drug Development;Investigational Medicinal Products (IMPs)Review: Key Features: Current textbooks are US (FDA)-based, but this book covers the European situationProvides an up-to-date review of the theoretical and practical basis of clinical research monitoring and GCP, including the latest International Council for Harmonisation (ICH) GCP revisionsThe author has more than 10 years of experience in training and education of clinical research monitors
Author : Carol L. Lake,Roberta L. Hines,Casey D. Blitt
Publisher : Unknown
Page : 610 pages
File Size : 46,9 Mb
Release : 2001
Category : Medical
ISBN : UOM:39015049509758
Drs. Carol L. Lake, Roberta L. Hines, and Casey D. Blitt*three highly regarded experts in the field*team up to produce this comprehensive, state-of-the-art resource on the current practices and equipment used in monitoring in clinical anesthesia and intensive care units today. This reference focuses on all aspects of clinical monitoring, including all major monitoring modalities * integrates information on pediatric monitoring into each chapter * employs a user-friendly organization by types of monitors*including cardiac, neuroanesthesia, and obstetric * and much more!
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Page : 304 pages
File Size : 46,5 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9780309316323
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.
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Page : 111 pages
File Size : 42,9 Mb
Release : 2016-11-07
Category : Medical
ISBN : 9780309442589
On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.
Author : Gloria Oblouk Darovic
Publisher : Saunders
Page : 740 pages
File Size : 49,8 Mb
Release : 2002
Category : Medical
ISBN : UOM:39015054425858
Through three editions, this comprehensive reference on hemodynamic monitoring for critical care nurses, whether novice or expert, has been respected for being practical and clinically reliable. The text concentrates on the educational needs of the clinician for optimal care of the patient
Author : Peter H Charlton
Publisher : Peter H Charlton
Page : 257 pages
File Size : 46,5 Mb
Release : 2021-08-27
Category : Technology & Engineering
ISBN : 8210379456XXX
The aim of this PhD thesis was to develop and assess the performance of techniques for continuous RR monitoring using ECG and PPG signals for use in wearable sensors to detect deteriorations.
Author : Edyta Niebrzegowska
Publisher : Troubador Publishing Ltd
Page : 64 pages
File Size : 46,9 Mb
Release : 2019-02-28
Category : Medical
ISBN : 9781789019926
This concise e-book provides clinicians as well as administrative personnel involved in clinical research with an understanding of documentation related to clinical trial monitoring activities at each stage of the study from planning and set up, through conduct and close-out.
