Clinical Trial Project Management

Author : T. C. George, Dr.
Publisher : CreateSpace
ISBN 13 : 9781503074132
Total Pages : 102 pages
Book Rating : 4.37/5 ( download)

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Download or read book 12 Essential Activities of Clinical Trial Project Management written by T. C. George, Dr. and published by CreateSpace. This book was released on 2014-11-01 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book includes 12 essential activities undertaken by a project manager which includes Project Milestones Planning and Forecasting, Cost Estimate and Financial Planning, Logistics Planning, Vendor Selection and Management, Creation of Trial Master file, Management of Regulatory Document Submission, Co-ordination of Individual Site Set-up Activities, Import Export Requirements for Clinical Trials, Organization of Investigator Training Meeting, Study Initiation, Conduct and Milestones Tracking, Audit(s) and Quality Assurance, Regulatory Inspection, Study Closeout: Trial Completion, Suspension, Termination.

Author : JoAnn Pfeiffer
Publisher : CRC Press
ISBN 13 : 1315299771
Total Pages : 292 pages
Book Rating : 4.78/5 ( download)

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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.

Author : Alexey Levashov
Publisher : Litres
ISBN 13 : 5040664451
Total Pages : 69 pages
Book Rating : 4.50/5 ( download)

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Download or read book Project Management in Clinical Trials written by Alexey Levashov and published by Litres. This book was released on 2021-05-25 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Richard Chamberlain
Publisher : Xlibris Corporation
ISBN 13 : 1796041599
Total Pages : 101 pages
Book Rating : 4.90/5 ( download)

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Download or read book Project Management of Clinical Trials written by Richard Chamberlain and published by Xlibris Corporation. This book was released on 2019-09-24 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Project Management of Clinical Trials describes how to apply project management principles to conduct clinical research studies. It describes the major deliverables from clinical research and then covers estimating dates, resources, and costs to produce those deliverables. Along with the book is a set of Excel spreadsheets that can be used to estimate the dates and costs to do different types of clinical trials.

Author : Chris Sauber
Publisher : Independently Published
ISBN 13 : 9781090349521
Total Pages : 218 pages
Book Rating : 4.21/5 ( download)

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Download or read book The Comprehensive Guide To Clinical Research written by Chris Sauber and published by Independently Published. This book was released on 2019-04-21 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 304 pages
Book Rating : 4.23/5 ( download)

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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.

Author : Martin Robinson
Publisher : Inst of Clinical Research
ISBN 13 : 1905238428
Total Pages : 62 pages
Book Rating : 4.22/5 ( download)

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Download or read book Clinical Trial Project Management written by Martin Robinson and published by Inst of Clinical Research. This book was released on 2008 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical research projects are frequently complex and may have a large element of uncertainty both during their conduct and in their final outcome. This book sets out to give tools and techniques to plan, track and conrol projects in clinical research.

Author : Ashok Kumar Peepliwal
Publisher : Elsevier
ISBN 13 : 0443136289
Total Pages : 352 pages
Book Rating : 4.83/5 ( download)

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Download or read book Clinical Trial Project Management written by Ashok Kumar Peepliwal and published by Elsevier. This book was released on 2023-11-15 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. Covers how to conduct clinical trials in detail Present useful, basic, and advanced statistical tools Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book

Author : Ruth Jennifer Cavalieri
Publisher : Nursing Knowledge International
ISBN 13 : 9781937554644
Total Pages : 262 pages
Book Rating : 4.43/5 ( download)

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Download or read book Clinical Research Manual written by Ruth Jennifer Cavalieri and published by Nursing Knowledge International. This book was released on 2013 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Nancy J. Stark
Publisher :
ISBN 13 : 9781889160092
Total Pages : 288 pages
Book Rating : 4.91/5 ( download)

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Download or read book Project Management written by Nancy J. Stark and published by . This book was released on 2003 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Complex to implement and insidious in their propensity for cost overruns and schedule delays, poorly managed clinical trials may postpone marketing applications and result in expensive "lost opportunities". In this book the traditional skills of project management -- conception, planning, implementation, monitoring, and close-out -- are applied to clinical research to help assure smooth implementation and on-time completion."--Clinical Device Group website.