Clinical Trials Office
The CTO assists in the start-up, execution and completion of a clinical research projects, in compliance with FDA requirements. The CTO maintains a staff of well-trained study coordinators, who can be assigned to support specific trials where Children’s Hospital is a site. The CTO also assists with developing and negotiating budgets, coordinates IRB submissions, assists in the submission of IND and IDE applications to the FDA, maintains a database of Hospital trials and expertise, and ensures that the knowledge and the expertise needed to comply with regulatory requirements are available. Located on the A-level of the Main Building, the CTO works with faculty on industry- and investigator-initiated clinical research projects; performs for-cause and not-for-cause educational audits for trials not undertaken by CTO study coordinators; and facilitates contact between principal investigators and sponsors or contract research organizations interested in conducting trials at the Hospital.