UF Health Cancer Institute Protocol Activation Guide: A Sponsor’s Guide to Initiating Clinical Trials at the UF Health Cancer Institute » UF Health Cancer Institute Protocol Activation Guide » Cancer Institute » UF Health Cancer Institute

Protocol Activation Process at a Glance

After receiving the site acceptance letter and all required startup documents (final Protocol, IBs, ICFs, Budget, CTA, study manuals, IT requirements, etc.), the study enters the active queue.
All trials are reviewed by the relevant Disease Site Group (typically meet monthly). Once approved, initial development begins. Timelines vary by trial complexity and queue position.
Once development is completed (2-4 weeks), trial will be submitted to the calendar build team with MCA to follow.
Regulatory startup specialist initiates essential documents and ICF drafts (with UF-required language). Biosafety and Radiation Safety (HURRC) reviews begin if applicable. If using SIP: Our team sends registration invites and completes investigator profiles. Investigators delegate profiles to our institution. The Regulatory Manager will address SIP registration questions.
After MCA finalization, budget negotiation begins. Once finalized, the trial is sent to UF’s Clinical Research Hub (CRH) for QA, Division of Sponsored Programs (DSP) for contracting, and Scientific Review and Monitoring Committee (SRMC) for review (meets 2nd & 4th Thursdays; deadline 1 week prior).
Final step: IRB submission. UF IRB uses WCG for industry-sponsored studies; UF templates are required, and sponsors may not submit on our behalf. WCG has rolling submissions with no deadlines. The SIV can be scheduled at the time of IRB submission. We kindly request to not send any lab kits or supplies until the SIV date has been scheduled.

Guidelines

The email listserv for the Protocol Activation Team is Protocol_activation@cancer.ufl.edu. Once a Protocol Activation Coordinator (PAC) has been assigned, they should be included in all correspondence until study activation to ensure smooth and efficient processing. Emails sent to the PAC or listserv should receive a response within 24 to 48 business hours.

Please note that some details may vary slightly depending on the complexity of the study; however, the processes and guidelines outlined here represent the typical expectations for protocol activation. Information on this page is meant for use by study sponsors engaged with the UF Health Cancer Institute for study activation and is meant to be confidential.

Acronyms and committees

BSC: BioSafety Committee, responsible for establishing, monitoring, and enforcing policies and procedures for work involving biohazardous materials and/or recombinant DNA molecules (in accordance with NIH guidelines)
CRH: Clinical Research Hub, responsible for initial QA of the Medicare Coverage Analysis and final financial QA prior to activation
DSG: Disease Site Group, responsible for initial review and endorsement of opening the trial at UF
DSP: Division of Sponsored Programs, responsible for contracting. The budget must be finalized and MCA must be reviewed by CRH contracting can begin
HURRC: HUman Radioisotope and Radiation Committee, responsible for review of radiological procedures that are administered solely for experimental or research, use of an investigational radiological device or investigational radiopharmaceutical, and use of radiological procedures when these procedures are the subject of the investigation
IRB: Institutional Review Board, final review of the study to ensure participants are adequately informed and protected
SRMC: Scientific Review and Monitoring Committee, reviews the study prior to IRB submission for scientific rigor and clinical impact

Timelines

The UF Health Cancer Institute is committed to efficient study activation, with a goal of IRB approval within 3 to 5 months of receiving all study documents and manuals. Although the UF Health Cancer Institute does not have a formal accelerated activation process, below are some tips for sponsors to accelerate activation:

Reduce negotiation time: