CRA Training Series: Volume 4 - Conducting the Study Initiation Visits (2018)

CRA Training Series: Volume 4 - Conducting the Study Initiation Visits

The fourth volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, focuses on Conducting the Study Initiation Visits. The main purpose of  a study initiation visit is to train the investigator and supporting study staff on the objectives of, and planned methodology for, a clinical study. The study initiation visit is crucial to the clinical investigation of a new drug or device because it provides an opportunity to confirm the approaches to scientific issues and detailed procedural matters before subjects have been enrolled. It is an excellent opportunity to “walk” through all aspects of the study. This volume contains the guidelines for planning, conducting, and documenting a study initiation visit. Specifically, the manual includes the following content:

• Objectives of a study initiation visit and its role in the overall conduct of a clinical study
• The essential preparations for a successful study initiation visit
• The tasks that must be performed during the study initiation visit
• Explanation of the necessary documentation and the follow-up steps that must be completed after a study initiation visit has been conducted

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