Office of Sponsor and Regulatory Oversight

Division Of Basic Sciences - Nci

Investigators

Abstract

As part of establishing the office the following activities were accomplished: 1. Gap analysis and need assessment is an ongoing activity. 2. Safety reporting for Serious Adverse Events (SAEs) that meet the Suspected and Unexpected Serious Adverse Reactions (SUSAR) had been established, including processes and procedures for reporting other adverse event for collaborators. 3. Clinical Monitoring activities are being established. 4. Advisory Board had been established and had its inaugural meeting. 5. Support contract activities had been initiated. 6. Processes and procedures for protocol review, manufacturing deviations had been developed. 7. QMS system is being developed. 8. Regulatory submission have been maintained. 9. Agreements templates had been developed with Tech Transfer.