Clinical Research Monitoring
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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
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.
Data Monitoring In Clinical Trials
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Author : David L. DeMets
language : en
Publisher: Springer Science & Business Media
Release Date : 2006-06-22
Data Monitoring In Clinical Trials written by David L. DeMets and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-06-22 with Medical categories.
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.
The Cra S Guide To Monitoring Clinical Research
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Author : Karen E. Woodin
language : en
Publisher: Centerwatch Incorporated
Release Date : 2011-06
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 2011-06 with Medical categories.
The CRA's Guide to Monitoring Clinical Research, now in its third edition, continues to be a key resource for both novice and experienced CRAs seeking to learn more about the field of monitoring or to better understand their roles and responsibilities as the industry becomes more global and technologically focused. With helpful tips and strategies, checklists, personal experiences, key takeaways and exercises, plus new chapters on clinical trial roles and responsibilities, monitoring for device and biologic trials, globalization of studies, EDC and more, The CRA's Guide is a must-have training and educational tool that you ll refer to again and again. Topics include: * -A comprehensive review of CRA roles and responsibilities * Understanding regulations and GCPs * Study initiation and monitoring plans * Recruiting and retaining study subjects -The informed consent process * Conducting adverse event and safety monitoring * Preparing for audits and detecting fraud * The future outlook * Job descriptions and current academic programs * Devices and Biologics * Managing Multi-national Trials * IRBs and Data Safety Monitoring Boards * Exercises with Answers Recommended for: -Novice and experienced CRAs * Health professionals interested in pursuing a career as a study monitor * Instructors conducting training and educational programs
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
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.
Statistical Monitoring Of Clinical Trials
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Author : Lemuel A. Moyé
language : en
Publisher: Springer Science & Business Media
Release Date : 2006-02-28
Statistical Monitoring Of Clinical Trials written by Lemuel A. Moyé and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-02-28 with Medical categories.
Statistical Monitoring of Clinical Trials: Fundamentals for Investigators introduces the investigator and statistician to monitoring procedures in clinical research. Clearly presenting the necessary background with limited use of mathematics, this book increases the knowledge, experience, and intuition of investigations in the use of these important procedures now required by the many clinical research efforts. The author provides motivated clinical investigators the background, correct use, and interpretation of these monitoring procedures at an elementary statistical level. He defines terms commonly used such as group sequential procedures and stochastic curtailment in non-mathematical language and discusses the commonly used procedures of Pocock, O’Brien–Fleming, and Lan–DeMets. He discusses the notions of conditional power, monitoring for safety and futility, and monitoring multiple endpoints in the study. The use of monitoring clinical trials is introduced in the context of the evolution of clinical research and one chapter is devoted to the more recent Bayesian procedures. From the reviews: "The author has a wealth of experience in this area and this is demonstrated throughout the text with relevant poignant examples." Short Book Reviews of the ISI, June 2006
Troubleshooting Monitoring
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Author : Zoe Binns
language : en
Publisher: Inst of Clinical Research
Release Date : 2006-08
Troubleshooting Monitoring written by Zoe Binns 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 2006-08 with categories.
Provides a synopsis of some of the potential issues that may arise when undertaking monitoring visits throughout the world, including real life case studies and how they were dealt with and resolved. In addition this monograph has a number of tips and some advice to help you with monitoring at home and in foreign countries and can provide you with some of the knowledge and confidence you need to carry out successful monitoring visits.
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.
Statistical Monitoring Of Clinical Trials
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Author : Michael A. Proschan
language : en
Publisher: Springer Science & Business Media
Release Date : 2006-12-31
Statistical Monitoring Of Clinical Trials written by Michael A. Proschan and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-12-31 with Medical categories.
The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion ("the B-value") – irrespective of the test statistic. Thus, this book offers statisticians an accessible, incremental approach to understanding Brownian motion as related to clinical trials.