The Cra S Guide To Monitoring Clinical Research
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The Cra S Guide To Monitoring Clinical Research
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Author : Elizabeth Weeks-Rowe
language : en
Publisher:
Release Date : 2019
The Cra S Guide To Monitoring Clinical Research written by Elizabeth Weeks-Rowe and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with Clinical trials categories.
The Cra S Guide To Monitoring Clinical Research
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Author : Karen E. Woodin
language : en
Publisher: Centerwatch Incorporated
Release Date : 2008-01-01
The Cra S Guide To Monitoring Clinical Research written by Karen E. Woodin and has been published by Centerwatch Incorporated this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-01-01 with Medical categories.
The Cra S Guide To Monitoring Clinical Research
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Author : Karen E. Woodin
language : en
Publisher: CenterWatch
Release Date : 2003-01-01
The Cra S Guide To Monitoring Clinical Research written by Karen E. Woodin and has been published by CenterWatch this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-01-01 with Medical categories.
The Crc S Guide To Coordinating Clinical Research
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Author : Karen E. Woodin
language : en
Publisher: CenterWatch
Release Date : 2004
The Crc S Guide To Coordinating Clinical Research written by Karen E. Woodin and has been published by CenterWatch this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Medical categories.
This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to apply them in clinical trials and organizing a clinical practice.
Clinical Research Coordinator Handbook
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Author : Deborrah Norris
language : en
Publisher: Plexus Publishing (UK)
Release Date : 2004
Clinical Research Coordinator Handbook written by Deborrah Norris and has been published by Plexus Publishing (UK) this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Clinical trials categories.
In this revised third edition of the essential reference for clinical research coordinators (CRCs), Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The book's five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, a glossary, and more.
A Clinical Trials Manual From The Duke Clinical Research Institute
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Author : Margaret Liu
language : en
Publisher: John Wiley & Sons
Release Date : 2011-08-24
A Clinical Trials Manual From The Duke Clinical Research Institute written by Margaret Liu and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-24 with Medical categories.
"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.
Documentation Of Clinical Trial Monitoring
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Author : Edyta Niebrzegowska
language : en
Publisher: Troubador Publishing Ltd
Release Date : 2019-02-28
Documentation Of Clinical Trial Monitoring written by Edyta Niebrzegowska and has been published by Troubador Publishing Ltd this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-02-28 with Medical categories.
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.
Reviewing Clinical Trials
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Author : Chinese University of Hong Kong
language : en
Publisher:
Release Date : 2010
Reviewing Clinical Trials written by Chinese University of Hong Kong and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Clinical trials categories.
The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
Sharing Clinical Trial Data
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-04-20
Sharing Clinical Trial Data written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-20 with Medical categories.
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.
Clinical Research Monitoring A European Approach
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Author : Van Dooren A A
language : en
Publisher: World Scientific
Release Date : 2017-09-21
Clinical Research Monitoring A European Approach written by Van Dooren A A and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-21 with Medical categories.
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