Clinical Trials Office

The mission of the IU Simon Comprehensive Cancer Center Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCCC translational clinical investigators. The CTO is a centralized resource to facilitate the development, completion and management of oncology clinical trials at IU Simon Comprehensive Cancer Center..

The CTO provides the following:

  • Protocol management, screening, monitoring, treatment administration, and reporting of adverse events.
  • Coordinates the scientific review (SRC) of proposed trials.
  • Assist in protocol development including IND/IDE management.
  • Initial and ongoing preparation of regulatory documents for submission to the IRB and other appropriate agencies.
  • Data collection and management.
  • Budget preparation and negotiation.
  • Investigator-initiated multicenter network.

The experienced support staff of the Clinical Trials Office provides essential services, which enable the clinical investigator to efficiently conduct clinical trials in an increasingly complex regulatory and financial environment. The CTO provides a comprehensive range of services. The complexity of both clinical and translational trials continues to increase at a time when the conduct of trials is under greater regulatory scrutiny. These services begin in the early stages of protocol development and continue throughout the study implementation, publication and long-term follow-up. There is a need to maximize the information yield of clinical trials and to assure human safety. The CTO facilitates the conduct of a successful clinical trials program of this magnitude by providing a professionally diverse, talented staff and highly efficient organization.