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Documentation Of Clinical Trial Monitoring
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Book Synopsis Documentation of Clinical Trial Monitoring by : Edyta Niebrzegowska
Download or read book Documentation of Clinical Trial Monitoring written by Edyta Niebrzegowska and published by Troubador Publishing Ltd. This book was released on 2019-02-28 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Clinical Research Monitoring: A European Approach by : Van Dooren A A
Download or read book Clinical Research Monitoring: A European Approach written by Van Dooren A A and published by World Scientific. This book was released on 2017-09-21 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis The Fundamentals of Clinical Research by : P. Michael Dubinsky
Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis A Practical Guide to Managing Clinical Trials by : JoAnn Pfeiffer
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Book Synopsis Archiving Clinical Trial Documents by : Elizabeth Hooper
Download or read book Archiving Clinical Trial Documents written by Elizabeth Hooper and published by Inst of Clinical Research. This book was released on 2006-06 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by : Institute of Medicine
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Book Synopsis The Clinical Trial Protocol by : Sue Fitzpatrick
Download or read book The Clinical Trial Protocol written by Sue Fitzpatrick and published by Inst of Clinical Research. This book was released on 2005-12 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The CRA's Guide to Monitoring Clinical Research by : Karen E. Woodin
Download or read book The CRA's Guide to Monitoring Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2003-01-01 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Design, Execution, and Management of Medical Device Clinical Trials by : Salah M. Abdel-aleem
Download or read book Design, Execution, and Management of Medical Device Clinical Trials written by Salah M. Abdel-aleem and published by John Wiley & Sons. This book was released on 2009-09-08 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.
Book Synopsis Principles of Good Clinical Practice by : Michael J. McGraw
Download or read book Principles of Good Clinical Practice written by Michael J. McGraw and published by Pharmaceutical Press. This book was released on 2010 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Book Synopsis A Clinical Trials Manual From The Duke Clinical Research Institute by : Margaret Liu
Download or read book A Clinical Trials Manual From The Duke Clinical Research Institute written by Margaret Liu and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
Author :Gerhard Fortwengel Publisher :Karger Medical and Scientific Publishers ISBN 13 :3805576552 Total Pages :113 pages Book Rating :4.8/5 (55 download)
Book Synopsis Guide for Clinical Trial Staff by : Gerhard Fortwengel
Download or read book Guide for Clinical Trial Staff written by Gerhard Fortwengel and published by Karger Medical and Scientific Publishers. This book was released on 2004 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: The standard to which clinical trials must conform is called 'Good Clinical Practice' (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted. This book will be an indispensable companion for those conducting clinical trials and should have a fixed place in the library of every investigator and his staff.
Book Synopsis Clinical Trials Audit Preparation by : Vera Mihajlovic-Madzarevic
Download or read book Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and published by John Wiley & Sons. This book was released on 2010-09-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Book Synopsis Guide for Investigator Initiated Trials by : G. Fortwengel
Download or read book Guide for Investigator Initiated Trials written by G. Fortwengel and published by Karger Medical and Scientific Publishers. This book was released on 2011-04-04 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the ‘International Conference on Harmonization and Good Clinical Practice’. This makes the publication at hand an essential ‘cookbook’ for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.
Book Synopsis Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS by : Richard C. Zink
Download or read book Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS written by Richard C. Zink and published by SAS Institute. This book was released on 2014-07-01 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improve efficiency while reducing costs in clinical trials with centralized monitoring techniques using JMP and SAS. International guidelines recommend that clinical trial data should be actively reviewed or monitored; the well-being of trial participants and the validity and integrity of the final analysis results are at stake. Traditional interpretation of this guidance for pharmaceutical trials has led to extensive on-site monitoring, including 100% source data verification. On-site review is time consuming, expensive (estimated at up to a third of the cost of a clinical trial), prone to error, and limited in its ability to provide insight for data trends across time, patients, and clinical sites. In contrast, risk-based monitoring (RBM) makes use of central computerized review of clinical trial data and site metrics to determine if and when clinical sites should receive more extensive quality review or intervention. Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS presents a practical implementation of methodologies within JMP Clinical for the centralized monitoring of clinical trials. Focused on intermediate users, this book describes analyses for RBM that incorporate and extend the recommendations of TransCelerate Biopharm Inc., methods to detect potential patient-or investigator misconduct, snapshot comparisons to more easily identify new or modified data, and other novel visual and analytical techniques to enhance safety and quality reviews. Further discussion highlights recent regulatory guidance documents on risk-based approaches, addresses the requirements for CDISC data, and describes methods to supplement analyses with data captured external to the study database. Given the interactive, dynamic, and graphical nature of JMP Clinical, any individual from the clinical trial team - including clinicians, statisticians, data managers, programmers, regulatory associates, and monitors - can make use of this book and the numerous examples contained within to streamline, accelerate, and enrich their reviews of clinical trial data. The analytical methods described in Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS enable the clinical trial team to take a proactive approach to data quality and safety to streamline clinical development activities and address shortcomings while the study is ongoing. This book is part of the SAS Press
Book Synopsis Archiving Clinical Trial Documents by : Elizabeth Hooper
Download or read book Archiving Clinical Trial Documents written by Elizabeth Hooper and published by . This book was released on 2006 with total page 50 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gives advice on how to design a clinical trial and compares the different designs.
