Investigator-Initiated Trial Concept Development Group
To submit for pre-review, a concept must first be endorsed by the respective DSG research leader. The endorsed pre-review form should then be submitted to PDO@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 investigation (ADCI).
CDG Pre-review Workflow
For full details of the UFHCC IIT Policy: UFHCC Process for Investigator-Initiated Trial Review, Approval, Development and Activation
For information related to the CDG, please contact Alisha Daniels, research manager, at firstname.lastname@example.org or 352.294.8568.
The UFHCC recognizes that a common barrier to successful trial completion is inadequate resource allocation. As a steward of limited resources, the UFHCC Feasibility Group (FG) is responsible for reviewing or providing feedback on the non-scientific aspects of a study being considered. The goal is to assist PIs and DSGs in ensuring adequate institutional, financial, personnel and patient resources are available. The UFHCC FG provides this information as a required component of the UFHCC CRO-managed protocol development and as a consultant to other UFHCC investigators. The FG issues a recommendation of feasible or non-feasible for each study reviewed to supplement DSG decision making.
FG meets every first and third Tuesday of the month and submissions for review are due the week prior to the meeting date by 12:00 pm. Protocols and budget drafts should be submitted to Protocol_Activation@cancer.ufl.edu.
Feasibility Group Members
|Associate Director for Clinical Investigation||Thomas George, M.D., FACP|
|Associate Director for Medical Affairs||Merry-Jennifer Markham, M.D.|
|Associate Director for Administration||Robert Houlihan, DHA, MBA, FACHE, CCRP, CRA|
|Administrative Director||Alison Ivey, R.N., MS, OCN, CCRP|
|Assistant Director of Clinical Operations||Leslie Pettiford, R.N., MS, OCN, CCRC|
|Assistant Director of Clinical Research Admin & Compliance||TBD|
|Manager, Project Management Office||Alisha Daniels, M.D., MHA, CCRC|
|Manager, Regulatory||Ashley Anderson, MBA, ACRP-CP|
Core Feasibility Group members represent voting members and are responsible for making recommendations on proposed trials. The complete membership listing of Feasibility Group Members is available in the FG Charter.
For information related to the Feasibility Group, please contact Alisha Daniels, research manager, at email@example.com or 352.294.8568.