UF Human Subjects Research usually requires additional submissions, reviews, and approvals before the study can start. Depending on the specifics of the research protocol, these additional reviews might include:
Federal
- FDA (US Food and Drug Administration)
- GCP (Good Clinical Practice)
- Medicare Pre-approval for FDA Investigational Device Exemption (IDE) Studies
Institutional Review Board (IRB)
- IRB-01 Gainesville Health Science Center
- IRB-02 Behavioral/NonMedical
- IRB-04 Western IRB (WIRB) for industry-supported clinical research
- sIRB Single/Central/Ceded IRB for NIH Multisite studies
Office of Clinical Research (OCR)
- Clinical Research Billing Compliance (RBC)
- ClinicalTrials.gov Applicability
- Informed Consent Financial Language Assessment
- OnCore Clinical Research Management System Set-up
UF Health Cancer Center
- Cancer Data Integrity and Safety Committee (DISC)
- Cancer Investigator-Initiated Trial (IIT) Think Tank
- Cancer Scientific Review and Monitoring Committee (SMRC)