Program Management

Working closely with the Principal Investigator from initial design to completion and publication, the team supports and oversees the conduct of the entire study, including activity at investigative sites internationally. The team is involved in protocol development; the design of Case Report Forms (CRF’s) with the Data Management Team; data checks and queries to review and confirm data integrity; review of site criteria and selection of sites; study-specific training and follow-up for protocol compliance; accurate and complete data collection at each site; and at study completion, the preparation of the database lock to allow for the statistical analysis and reporting.

The study team is also the center for communications with investigative sites, sponsors and collaborators, as well as the Operations Committee of Key Opinion Leaders (KOLs) and the Adjudication and Data Monitoring Safety Boards.