Clinical Research Monitoring A European Approach
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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
Clinical Research Monitoring
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Author : A. A. Van Dooren
language : en
Publisher:
Release Date : 2017
Clinical Research Monitoring written by A. A. Van Dooren and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with Clinical medicine categories.
Patient Recruitment In Clinical Research
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Author : Danielle Jacobs
language : en
Publisher: Inst of Clinical Research
Release Date : 2005
Patient Recruitment In Clinical Research written by Danielle Jacobs and has been published by Inst of Clinical Research this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Clinical trials categories.
Provides ideas for how to improve patient recruitment for clinical trials.
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.
The Fundamentals Of Clinical Research
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Author : P. Michael Dubinsky
language : en
Publisher: John Wiley & Sons
Release Date : 2022-01-26
The Fundamentals Of Clinical Research written by P. Michael Dubinsky 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 2022-01-26 with Medical categories.
This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
The Pocket Guide To The Eu Directives For Clinical Research
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Author : Julie Meeson
language : en
Publisher: Inst of Clinical Research
Release Date : 2009
The Pocket Guide To The Eu Directives For Clinical Research written by Julie Meeson and has been published by Inst of Clinical Research this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Clinical trials categories.
Data Monitoring Committees In Clinical Trials
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Author : Susan S. Ellenberg
language : en
Publisher: John Wiley & Sons
Release Date : 2019-01-15
Data Monitoring Committees In Clinical Trials written by Susan S. Ellenberg 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 2019-01-15 with Medical categories.
The authoritative guide for Data Monitoring Committees—fully revised and updated The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees. Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight. Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making. • Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees • Illustrates the types of challenging issues Data Monitoring Committees face in practical situations • Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations • Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research • Expands treatment of current journal publications addressing DMC issues Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.
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.
Project Management In Clinical Trials
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Author : Alexey Levashov
language : en
Publisher: Litres
Release Date : 2021-05-25
Project Management In Clinical Trials written by Alexey Levashov and has been published by Litres this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-05-25 with Business & Economics categories.
The book is about both theoretical and practical aspects of Project Management in clinical trials. The audience may find explanation of different phenomena in modern clinical trials, for example, why some approaches in managing trials work and others – do not. In addition to this, the book should serve the purposes of business psychotherapy. The book is saturated with examples from real life and practical tips.
The Duty For Sponor Oversight In Clinical Trials
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Author : Doris Breiner
language : en
Publisher: BoD – Books on Demand
Release Date : 2022-12-22
The Duty For Sponor Oversight In Clinical Trials written by Doris Breiner and has been published by BoD – Books on Demand this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-22 with Science categories.
The first edition of the practical guide related to the topic The Duty for Sponsor Oversight in Clinical Research outlined the underlying requirements as well as possible approaches to implement it efficiently in small and mid-sized companies. This was based on a master's thesis released in April 2019. The next edition will focus on the Clinical Data Review which includes all aspects to be considered, for example, the outcome of the overall monitoring oversight activities. Furthermore, to describe and show examples of a standardized score assignment to ensure a unique process of the assessment.