CRA Training Series: Volume 6 - The CRA's Reference for Adverse Events

The sixth volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, The CRA’s Reference for Adverse Events is designed to serve as a practical teaching tool. The Clinical Research Associate (CRA)is responsible for verifying that the investigational site personnel are appropriately identifying, classifying, recording, and reporting adverse events (AEs). By accurately and effectively monitoring the study site's handling of AEs, CRAs ensure that the sponsor and study site members are acting within the bounds of the law, and perhaps more importantly, that study subjects are protected. This volume provides basic information on identifying, collecting, classifying, and reporting AEs. It is a compilation of regulatory information, procedural guidance, and learning exercises designed to provide immediate applicable instruction for dealing with AEs. Specifically, the manual includes the following content:

• Terms and concepts necessary to properly recognize AEs in clinical research
• Responsibilities of study site personnel in observing and managing AEs
• Review of CRFs and source documents for AEs
• Explanation of applicable U.S. and ICH regulations governing AE
• The classification process of AEs and how to handle those that are reportable

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