The Crc S Guide To Coordinating Clinical Research

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.

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

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.

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.

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 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.

CITI Progam's Clinical Research Coordinator (CRC) Guide provides clinical research professionals with information on operational and regulatory elements necessary for the ethical conduct of clinical trials. Information presented in this guide expands beyond but is directly connected to elements of Human Subjects Research (HSR) and Good Clinical Practice (GCP). Readers may find this guide most helpful if they have an understanding of these areas, as it will provide a foundation for many of concepts, ideas, and considerations presented.Each chapter consists of foundational text, supplemented by a number of case studies and resources, which are intended to help readers conceptualize and establish a greater understanding of the topic being discussed. Readers seeking further resources may access a resource database for clinical research professionals by signing up for the CITI Program's online CRC course. The resource database (presented as a module) outlines and provides links to various tools such as job aids, templates, reporting forms and guidance, FDA forms, best practices, federal regulations, international resources, ethical codes, and more.It is our hope that the content presented within this guide is operational in nature and will empower readers to perform their roles in clinical research efficiently and with confidence. This paperback edition is exclusively available at https://www.citiprogram.org/publications