CRA Training Series: Volume 3 - Conducting the Prestudy Visit (2018)

CRA Training Series: Volume 3 - Conducting the Prestudy Visit

The third volume of the 7-part Barnett Clinical Research Associate (CRA) Training Series (2018) and updated to include ICH GCP E6 R2, Conducting the Prestudy Visit provides guidance on how to conduct the Prestudy visit. Prestudy visits (PSVs), which are also called Site Selection Visits (SSVs), are conducted at a potential study site to introduce the prospective investigator to the study protocol and to familiarize the staff with regulatory obligations and sponsor procedures. In addition, the visit provides an occasion for you to assess the investigator's interest in and ability to carry out the study. This includes determining whether the potential investigator has the time, facilities, equipment, access to subjects, and staff necessary to conduct the study. Specifically, the manual includes the following content:

• How to schedule the meeting and how to prepare a meeting agenda 
• Budget negotiation techniques 
• Necessary discussions with site staff and the investigator — the drug, protocol, access to source    documents, case report forms (CRFs), and regulatory and sponsor obligations 
• Site assessment criteria
• Selection recommendation procedures and documentation

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