Office of Sponsor and Regulatory Oversight

Division Of Basic Sciences - Nci

Investigators

Abstract

The following activities were accomplished: Sponsor regulatory obligations were executed: 1. Safety reporting for Serious Adverse Events (SAEs) that meet the Suspected and Unexpected Serious Adverse Reactions (SUSAR), including processes and procedures for reporting other adverse event for collaborators. 2. Clinical Site Monitoring activities . 3. Safety oversight structures. 4. Pharmaceutical Support. 5. Regulatory submissions and communications 6. Processes and procedures for protocol review and approval 7. QMS system 8. Agreements review and approval 9. Medical writing activities.