- This manual provides guidance on how to conduct a prestudy visit. Specifically, the manual addresses the following:
- Shows how to schedule the meeting and how to prepare a meeting agenda.
- Suggests budget negotiation techniques
- Details the necessary discussions with site staff and investigator — the drug, protocol, access to source documents, case report forms (CRFs), and regulatory and sponsor obligations.
- Describes site assessment criteria.
- Presents selection recommendation procedures and documentation.
Volume 1-An Overview of Drug Development
Volume 2-Identifying and Screening Investigators
Volume 3-Conducting the Pre-study 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 Knowledge