Clinical Research Coordinator Handbook, 5th edition

 

“This extremely useful title is written for anyone planning to implement clinical trials at an institution. … the author has carefully detailed the types of forms, study records, and case report forms. … A powerful appendix and glossary of relevant terms help make this a needed book for any clinical trials office.”
— Journal of Hospital Librarianship

In this fully revised and expanded fifth edition of the essential reference for clinical research coordinators, 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, and a glossary.

This book covers these topics and more:

Federal Regulations/GCP and ICH Guidelines
Clinical Research Coordinator Responsibilities
Investigator Responsibilities
Obtaining Informed Consent/Assent
Creating and Examples of Source Documents
Electronic Data Capture (EDC)
Preparing for Regulatory Inspections
Reporting Study Results