The Office of Clinical Research (OCR) is responsible for reviewing all UF Human Subjects Research projects that meet criteria for any of the following:
OCR DOES NOT need to review Quality Improvement Projects that are solely designed to improve quality of care or patient safety. For more information, see the IRB webpage on QA/QI vs Research.
OCR DOES NOT need to review Expanded Access or Compassionate Use Protocols (EAPs) unless a UF contract and/or UF Health Investigational Drug Services (IDS) is involved. Please note that the UF IRB must review all UF Expanded Access cases – see http://irb.ufl.edu/wp-content/uploads/Expanded-Access-of-a-Test-Article.pdf.
What Studies Need Contract Negotiation?
UF Human Subjects Research projects with:
- A non-federal external sponsor
- A federal sponsor, but with money flowing through a CRO or other institution
- A sponsor providing equipment, drugs, devices
- Confidentiality Disclosure Agreements
- Clinical Research Agreements
- Prime Agreements or Sub-contracts
- Other contracts/agreements – examples:
- Memorandum of Understanding
- Letter of Indemnification
- Data Use Agreement
- Termination Letters
- Non-Monetary Device/Drug Provisions
- HSR-related Service Agreements
What Studies Need Research Billing Compliance Review?
UF Human Subjects Research projects with study services performed in a
- Hospital Ancillary Department (e.g. Lab, Radiology)
- UF Health Setting (inpatient or outpatient)
What Studies Need Epic Upload?
- Studies that generate patient-based charges in Epic are uploaded to assist with the Research Billing Compliance workflows.
- Studies that use UF Health Investigational Drug Services (IDS) are uploaded to utilize Epic SmartGroups.
- Epic myChart Recruitment studies are uploaded to assist with recruitment efforts.
What Studies Need OnCore Entry?
- UF Cancer-related studies reviewed by the Scientific Review and Monitoring Committee.
- Any other UF Human Subjects Research studies that include at least one of the following:
- Prospective assignment of subjects
- Intervention with therapeutic intent
- Measurement of health or behavioral outcomes
- Collection of health-related biomedical or behavioral data or samples
- Data collected in a clinic, hospital, research space, or the UF Clinical Research Center
- Sponsor invoicing
- Billable patient care costs
When new studies are submitted to the OCR, they are entered into OnCore. As older “legacy” studies are submitted to OCR for an amendment or revision, they are also added. In addition, departments may choose to have other studies entered into OnCore to simplify the management of their research portfolio.
The Scope of a Study Build in OnCore
Several factors determine how much of the OnCore functionality is set up and used on a given study. For example, some legacy studies may only take advantage of the OnCore record or “shell”, while a newer study might also use the calendar, budget, and/or invoicing modules, depending on the nature of the study.
The chart below shows how OCR determines the scope of an OnCore project build for new studies.
Click image to enlarge