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The Coordination of Clinical Research

Author : Mohit Bhandari

Publisher : Thieme

Page : 505 pages

File Size : 28,12 MB

Release : 2020-01-16

Category : Medical

ISBN : 3132582549

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Book Description

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

Page : 428 pages

File Size : 28,43 MB

Release : 2004

Category : Medical

ISBN :

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Book Description

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)

Page : 164 pages

File Size : 10,38 MB

Release : 2004

Category : Design

ISBN :

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Book Description

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 Manual

Author : Kane Williams

Publisher : Createspace Independent Publishing Platform

Page : 234 pages

File Size : 37,92 MB

Release : 2017-05-15

Category : Clinical trials

ISBN : 9781546939658

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Book Description

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?s Manual

Author : Kane Williams

Publisher :

Page : 234 pages

File Size : 10,23 MB

Release : 2017-05-15

Category :

ISBN : 9781546916833

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Book Description

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.



Responsible Research

Author : Philip A. Cola

Publisher : Remedica

Page : 118 pages

File Size : 28,91 MB

Release : 2006

Category : Medical

ISBN : 1901346684

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Book Description

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

Page : 248 pages

File Size : 38,60 MB

Release : 2012-09-13

Category : Medical

ISBN : 0309253187

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Book Description

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 Sourcebook for Clinical Research

Author : Natasha Martien

Publisher : Academic Press

Page : 278 pages

File Size : 37,4 MB

Release : 2018-08-01

Category : Medical

ISBN : 0128162430

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Book Description

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



23 Essential Activities of Clinical Research Coordinator (CRC)

Author : S. Fernandez

Publisher : Createspace Independent Publishing Platform

Page : 0 pages

File Size : 16,45 MB

Release : 2015-11-05

Category : Clinical trials

ISBN : 9781519204950

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Book Description

The book "23 Essential Activities of Clinical Research Coordinator: A complete guide to become a successful site coordinator" shares the experience of 11+ years and 57+ clinical trials operations of Dr. S Fernandez. This book will train all the clinical research personnel especially site coordinators and other site personnel on detailed job responsibilities of a CRC before, during and after completion of clinical trial study. The book covers insight on essential responsibilities like: Assessment of Site Feasibility, IRB Submission, Site Personnel Training, Facilitation of Site Monitoring and Auditing, Preparation of Site Binders, Drug Accountability, CRF Completion, Logs Update, AE/SAE Reporting, Deviation Reporting, Inventory Management, Data Archival etc.



Transforming Clinical Research in the United States

Author : Institute of Medicine

Publisher : National Academies Press

Page : 151 pages

File Size : 13,27 MB

Release : 2010-10-22

Category : Medical

ISBN : 0309163358

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Book Description

An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.