Investigator-Initiated Trial Concept Development Group

UFHCC PMO Group

The UF Health Cancer Center has a pre-review process for all cancer-relevant IITs categorized as “interventional treatment” or otherwise involving investigational drugs, devices or medical procedures.

This review, performed through the CDG, is mandatory for any IITs planning to utilize Cancer Center CRO resources including:

Concepts not meeting these specifications are exempt from this mandatory CDG pre-review, but may request this service.

The aims of this comprehensive review are to:

  • 1) improve the feasibility, scientific merit and ultimate success in completing cancer-relevant IITs
  • 2) shorten the timeframe from concept approval to protocol activation
  • 3) maximize staff and investigator effort in protocol development.

To submit for CDG pre-review, a concept must first be endorsed by the respective DSG research leader. The endorsed CDG pre-review form should then be submitted to PMO@cancer.ufl.edu for Project Management, Statistical, Budget and Scientific review to commence.  Reviewer comments will be provided to investigators along with scientific quality and feasibility assessments as endorsed by the Associate Director of Clinical Research (ADCR).

CDG Pre-Review Workflow

cdg diagram

Important Documents

For full details of the Cancer Center IIT Policy: Cancer Center Process for Investigator-Initiated Trial Review, Approval, Development and Activation

Contact

For information related to the CDG and the pre-review process, please contact the PMO Manager, Shannon Alford, MPH, CCRP at 352.294.8146 or salford@ufl.edu.