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Author: Karen E. Woodin Publisher: CenterWatch ISBN: Category : Medical Languages : en Pages : 428
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.
Author: Karen E. Woodin Publisher: CenterWatch ISBN: Category : Medical Languages : en Pages : 428
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.
Author: Deborrah Norris Publisher: Plexus Publishing (UK) ISBN: Category : Design Languages : en Pages : 164
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.
Author: Mohit Bhandari Publisher: Thieme ISBN: 3132582549 Category : Medical Languages : en Pages : 505
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.
Author: Kane Williams Publisher: Createspace Independent Publishing Platform ISBN: 9781546939658 Category : Clinical trials Languages : en Pages : 234
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.
Author: Karen E. Woodin Publisher: ISBN: 9781930624610 Category : Medical Languages : en Pages : 573
Book Description
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
Author: S. Fernandez Publisher: Createspace Independent Publishing Platform ISBN: 9781519204950 Category : Clinical trials Languages : en Pages : 0
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.
Author: Kane Williams Publisher: ISBN: 9781546916833 Category : Languages : en Pages : 234
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.
Author: Natasha Martien Publisher: Academic Press ISBN: 0128162430 Category : Medical Languages : en Pages : 278
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
Author: Margaret Liu Publisher: John Wiley & Sons ISBN: 1444357883 Category : Medical Languages : en Pages : 381
Book Description
"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: Karen E. Woodin
Author: Karen E. Woodin
Author: Deborrah Norris
Author: Mohit Bhandari
Author: Kane Williams
Author: Karen E. Woodin
Author: S. Fernandez
Author: Kane Williams
Author: Curtis L. Meinert
Author: Natasha Martien
Author: Margaret Liu