CRA Training Series: Volume 5 - Conducting Routine Monitoring Visits

The fifth volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, focuses on Conducting Routine Monitoring Visits. Clinical Research Associates (CRAs) must act as both detectives and troubleshooters. As a CRA you need a broad range of skills to fulfill your many responsibilities. This volume will assist you in developing the skills to confidently and effectively monitor clinical studies. It details the tasks performed in three types of monitoring visits — the first visit after a subject is enrolled; routine visits throughout the study; and the closeout, or final visit to the site. This manual covers the activities that take place after protocol planning, investigator selection, necessary regulatory submissions, negotiation of the study budget, site evaluation, and site training have been completed. Other volumes in this series cover those specific activities in more depth. Upon completion of the manual, you will be able to:

• List the monitoring objectives of CRAs
• Describe the sources and types of information needed for effective performance as a CRA
• Describe in detail the tasks that must be performed during a monitoring visit
• Outline the follow-up steps necessary after each monitoring visit and study closeout

Each volume can be purchased separately or the full 7-volume series can be purchased for $599.

Publications in this set include:

• Volume 1: An Overview of Drug Development
• Volume 2: Identifying and Screening Investigators
• Volume 3: Conducting the Prestudy Visit
• Volume 4: Conducting the Study Initiation Visits
• Volume 5: Conducting Routine Monitoring Visits
• Volume 6: The CRA's Reference for Adverse Events
• Volume 7: Test Your CRA Knowledge