Protocol Activation Process at a Glance
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:
- Master contract on file so that contract language is already agreed upon
- Agree to all site fees as-is
Parallel processing:
- Allow Site Initiation Visit to occur prior to IRB approval if need arises
Reduce extra administrative tasks:
- No amendments to be processed during the activation period
- Provide Medicare Coverage Analysis justifications with the budget
Frequently requested documents
Supporting documentation for institutional fees
Investigational pharmacy fees
Site Evaluation (SEV) Virtual Tours
Hematologic Malignancies
Solid Tumors
Other site documents
Site Profile
Electronic Medical Record Questionnaire (EMRQ)
UF Required Cost and Injury Language
UF FWA and SIP Facility ID
Commonly Requested Standard Operating Procedures (SOPs) and Policies:
Informed consent
Investigational Pharmacy
- CTSI IDS – Destruction and Return of Investigational Medications
- CTSI IDS – Medication Storage and Temperature Monitoring
- CTSI IDS – Ordering and Dispensation of Investigational Drugs
- Main IDS – Investigational Medications Destruction and Return
- Main IDS – Investigational Products Storage and Temperature Monitoring
Site Visits
Note: All SEVs are conducted remotely. Sponsors are permitted one on-site visit per year, inclusive of the SIV.
- Monitoring Visits Policy
- Site Evaluation Visits (SEVs) Policy
- Site Initiation Visits (SIVs) Policy
- SOP- Site Visits
- SOP- SIV Meetings
- Space Policy for Monitors
Other SOPs and Policies
- Clinical Trial Kits Policy
- Disaster Recovery Plan
- Electronic Signatures Policy
- Ophthalmology Memo
- PI Responsibilities and Oversight
- SOP- Access to EMR
- SOP-Data Capture and Entry
- SOP- Electronic Regulatory Files
- SOP- Emergency Preparedness
- SOP- External Safety Reports
- SOP- Maintenance of Hospital Equipment
- SOP- Master DOA Log
- SOP- Radiologic Response Assessment
- SOP- Research Lab Results
- SOP- Retention of Source Documents
- SOP- Subject Review and Verification
Our Team
Kiara Barker MPH
Ashley D Anderson MBA, ACRP-CP
Protocol Activation Coordinators
Finance/Budget/Post-Award Team
Regulatory Manager
