The Coordination Of Clinical Research

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The Coordination of Clinical Research

Author : Mohit Bhandari
Publisher : Thieme
ISBN 13 : 3132582549
Total Pages : 505 pages
Book Rating : 4.1/5 (325 download)

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Book Synopsis The Coordination of Clinical Research by : Mohit Bhandari

Download or read book The Coordination of Clinical Research written by Mohit Bhandari and published by Thieme. This book was released on 2020-01-16 with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt: A novel and indispensable handbook for clinical research coordinators worldwide Because "saying isn't doing; doing is doing": This fourth volume in Mohit Bhandari's series of methodology books, conceived as a transformational guide to executing research for those who coordinate it on a daily basis, focuses not on the design of research projects, but rather on the actual execution of such projects. Key Features: International group of authors and practicing research coordinators with decades of collective hands-on experience Includes many crucial, but often neglected, topics such as principles of successful grant writing, working with study budgets, ethics and consent forms, regulatory versus standard trials, coordinating and conducting observational research and randomized clinical trials, and much more Many helpful templates and sample forms with checklists, consent forms, budget outlines, and more A broad readership including scientists, physicians, surgeons, epidemiologists and statisticians, and industry research and development directors will welcome this unique and valuable book.

The CRC's Guide to Coordinating Clinical Research

Author : Karen E. Woodin
Publisher : CenterWatch
ISBN 13 :
Total Pages : 428 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The CRC's Guide to Coordinating Clinical Research by : Karen E. Woodin

Download or read book The CRC's Guide to Coordinating Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2004 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : Deborrah Norris
Publisher : Plexus Publishing (UK)
ISBN 13 :
Total Pages : 164 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Clinical Research Coordinator Handbook by : Deborrah Norris

Download or read book Clinical Research Coordinator Handbook written by Deborrah Norris and published by Plexus Publishing (UK). This book was released on 2004 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Clinical Research Coordinator?s Manual

Author : Kane Williams
Publisher :
ISBN 13 : 9781546916833
Total Pages : 234 pages
Book Rating : 4.9/5 (168 download)

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Book Synopsis Clinical Research Coordinator?s Manual by : Kane Williams

Download or read book Clinical Research Coordinator?s Manual written by Kane Williams and published by . This book was released on 2017-05-15 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is divided into 25 chapters covering more than 300 topics. This book will serve as a training guide to make your routine tasks more efficient, compliant and easy. After reading this book, Clinical Research Coordinators, clinical research personnel and aspirants would get:# Step by step in-depth training on roles and responsibilities of a clinical research coordinator before, during and after the completion of a clinical trial.# Discussion on day-to-day challenges and their solutions.# Training through real-time examples and ready-made checklists to conduct each activity more efficiently and correctly.# Guidance through strategies and measures to execute critical clinical trial activities.# Training on regulatory and ICH-GCP guidelines.# Tips on effective communication and coordination with site staff, investigator, sponsor, and IRB.# Assistance to become a better and successful clinical research coordinator. # Knowledge on other essential topics of clinical research.

Clinical Research Coordinator Manual

Author : Kane Williams
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781546939658
Total Pages : 234 pages
Book Rating : 4.9/5 (396 download)

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Book Synopsis Clinical Research Coordinator Manual by : Kane Williams

Download or read book Clinical Research Coordinator Manual written by Kane Williams and published by Createspace Independent Publishing Platform. This book was released on 2017-05-15 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is divided into 25 chapters covering more than 300 topics. This book will serve as a training guide to make your routine tasks more efficient, compliant and easy. After reading this book, Clinical Research Coordinators, clinical research personnel and aspirants would get: # Step by step in-depth training on roles and responsibilities of a clinical research coordinator before, during and after the completion of a clinical trial. # Discussion on day-to-day challenges and their solutions. # Training through real-time examples and ready-made checklists to conduct each activity more efficiently and correctly. # Guidance through strategies and measures to execute critical clinical trial activities. # Training on regulatory and ICH-GCP guidelines. # Tips on effective communication and coordination with site staff, investigator, sponsor, and IRB. # Assistance to become a better and successful clinical research coordinator. # Knowledge on other essential topics of clinical research.

The Sourcebook for Clinical Research

Author : Natasha Martien
Publisher : Academic Press
ISBN 13 : 0128162430
Total Pages : 278 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis The Sourcebook for Clinical Research by : Natasha Martien

Download or read book The Sourcebook for Clinical Research written by Natasha Martien and published by Academic Press. This book was released on 2018-08-01 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly

The CRC's Guide to Coordinating Clinical Research

Author : Karen E. Woodin
Publisher : CenterWatch
ISBN 13 :
Total Pages : 434 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The CRC's Guide to Coordinating Clinical Research by : Karen E. Woodin

Download or read book The CRC's Guide to Coordinating Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2004 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Responsible Research

Author : Philip A. Cola
Publisher : Remedica
ISBN 13 : 1901346684
Total Pages : 118 pages
Book Rating : 4.9/5 (13 download)

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Book Synopsis Responsible Research by : Philip A. Cola

Download or read book Responsible Research written by Philip A. Cola and published by Remedica. This book was released on 2006 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The editors (of U. Hospitals of Cleveland and Rx Trials, Inc.) offer a guide to the practical and ethical issues in the conduct of clinical research coordinators that places the topic in broad international perspective by including approaches from the European Union, Japan, Canada, and the United States. Thirteen chapters discuss ethics and human subjects protection, responsible conduct, the informed consent process, pediatric informed consent and assent, study implementation and start-up, recruitment and retention of research subjects, documentation, quality assurance in clinical trials, communication, education and training, and future trends in professionalization. Distributed in the US by BookMasters. Annotation :2006 Book News, Inc., Portland, OR (booknews.com).

Envisioning a Transformed Clinical Trials Enterprise in the United States

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309253187
Total Pages : 248 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Envisioning a Transformed Clinical Trials Enterprise in the United States by : Institute of Medicine

Download or read book Envisioning a Transformed Clinical Trials Enterprise in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.

The Role of Purchasers and Payers in the Clinical Research Enterprise

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309182905
Total Pages : 120 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Role of Purchasers and Payers in the Clinical Research Enterprise by : Institute of Medicine

Download or read book The Role of Purchasers and Payers in the Clinical Research Enterprise written by Institute of Medicine and published by National Academies Press. This book was released on 2002-06-14 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.

Closing the Quality Gap

Author : Kaveh G. Shojania
Publisher :
ISBN 13 : 9781587632594
Total Pages : 7 pages
Book Rating : 4.6/5 (325 download)

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Book Synopsis Closing the Quality Gap by : Kaveh G. Shojania

Download or read book Closing the Quality Gap written by Kaveh G. Shojania and published by . This book was released on 2004 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Evaluation of the Congressionally Directed Medical Research Programs Review Process

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309450047
Total Pages : 165 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Evaluation of the Congressionally Directed Medical Research Programs Review Process by : National Academies of Sciences, Engineering, and Medicine

Download or read book Evaluation of the Congressionally Directed Medical Research Programs Review Process written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-12-19 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: The medical research landscape in the United States is supported by a variety of organizations that spend billions of dollars in government and private funds each year to seek answers to complex medical and public health problems. The largest government funder is the National Institutes of Health (NIH), followed by the Department of Defense (DoD). Almost half of DoD's medical research funding is administered by the Congressionally Directed Medical Research Programs (CDMRP). The mission of CDMRP is to foster innovative approaches to medical research in response to the needs of its stakeholdersâ€"the U.S. military, their families, the American public, and Congress. CDMRP funds medical research to be performed by other government and nongovernmental organizations, but it does not conduct research itself. The major focus of CDMRP funded research is the improved prevention, diagnosis, and treatment of diseases, injuries, or conditions that affect service members and their families, and the general public. The hallmarks of CDMRP include reviewing applications for research funding using a two-tiered review process, and involving consumers throughout the process. Evaluation of the Congressionally Directed Medical Research Programs Review Process evaluates the CDMRP two-tiered peer review process, its coordination of research priorities with NIH and the Department of Veterans Affairs, and provides recommendations on how the process for reviewing and selecting studies can be improved.

The CRC's Guide to Coordinating Clinical Research

Author : Karen E. Woodin
Publisher :
ISBN 13 : 9781930624610
Total Pages : 573 pages
Book Rating : 4.6/5 (246 download)

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Book Synopsis The CRC's Guide to Coordinating Clinical Research by : Karen E. Woodin

Download or read book The CRC's Guide to Coordinating Clinical Research written by Karen E. Woodin and published by . This book was released on 2011-06 with total page 573 pages. Available in PDF, EPUB and Kindle. Book excerpt: New chapters, updated content, more tips, helpful exercises and more! The CRC's Guide to Coordinating Clinical Research has been one of the foremost training tools and reference guides for novice and experienced coordinators since the first edition was released in 2004. Now with new chapters on investigational product accountability, device and biologics trials and data safety monitoring boards, along with key takeaways and newly added case studies, The CRC's Guide is the most comprehensive resource available for on-site training staffs, professors or individuals interested in a step-by-step approach to coordinating successful clinical trials. Topics include: A comprehensive review of CRC roles and responsibilities Understanding regulations and GCPs Preparing for a study Working with study subjects The informed consent process Case report forms and EDC Study closure The future outlook Job descriptions and current academic programs Adverse Events and Safety Monitoring Sample Forms, Checklists and Logs Recommended for: Novice and experienced CRCs Health professionals interested in pursuing a career as a study coordinator Instructors conducting training and educational programs

Clinical Research Nursing

Author : International Association for Clinical Research Nurses
Publisher :
ISBN 13 : 9781558106758
Total Pages : 106 pages
Book Rating : 4.1/5 (67 download)

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Book Synopsis Clinical Research Nursing by : International Association for Clinical Research Nurses

Download or read book Clinical Research Nursing written by International Association for Clinical Research Nurses and published by . This book was released on 2016 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical research nursing focuses on the care of research participants and the protocols of clinical research and trials. The clinical researcher nurse (CRN) balances the needs of the participant and the requirements of research across settings. The result: exceptional, ethical, and safe care that yields reliable, valid data and findings, high quality research outcomes, and, in time, better quality health care. The premier resource for today's CRN, Clinical Research Nursing: Scope and Standards of Practice is informed by advances in this specialty's unique body of knowledge: nursing care; rese.

A Comprehensive and Practical Guide to Clinical Trials

Author : Delva Shamley
Publisher : Academic Press
ISBN 13 : 0128047305
Total Pages : 210 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis A Comprehensive and Practical Guide to Clinical Trials by : Delva Shamley

Download or read book A Comprehensive and Practical Guide to Clinical Trials written by Delva Shamley and published by Academic Press. This book was released on 2017-06-07 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank

Principles and Practice of Clinical Research

Author : John I. Gallin
Publisher : Elsevier
ISBN 13 : 9780080489568
Total Pages : 448 pages
Book Rating : 4.4/5 (895 download)

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Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government

The Learning Healthcare System

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133939
Total Pages : 374 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Learning Healthcare System by : Institute of Medicine

Download or read book The Learning Healthcare System written by Institute of Medicine and published by National Academies Press. This book was released on 2007-06-01 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care.