Office of Sponsor and Regulatory Oversight

Division Of Basic Sciences - Nci

Investigators

Abstract

The following activities were accomplished: 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. Establishing the pharmaceutical part of the Office 4. Advisory Board . 5. Support contract activities had been developed and in process of contract solicitation. 6. Processes and procedures for protocol review, manufacturing deviations had been developed. 7. QMS system has been developed. 8. Regulatory submission have been maintained. 9. Agreements templates had been developed with Tech Transfer. 10. eTMF contract had been established and work began on transition of data and documents.