Resources The Office of Research Affairs provides services to University of Florida College of Medicine – Jacksonville faculty, residents and fellows to support their research and scholarship activities in the areas of health disparities and health services research. Office of Research Affairs Portal To better drive the aims in our growing research ecosystem, the Office of Research Affairs portal, serves as a web-based "central doorway" for UF faculty and staff to access the Office of Research Affair's enhanced, research related services and resources. The goal of the portal is to connect investigators to the specific resources they need while improving the real-time analysis and tracking of research activities. To access the portal link, please follow the instructions below: Log in using the same username and password for logging into a UF Computer. Please note, umc\ must be added in front of the username if on a non-UF Computer. If you have any questions or require further assistance, please contact the Office of Research Affairs at (904) 244-9478. Office of Research Affairs Portal Office of Research Affairs Training Portal To ensure all research related training needs are available for new and current UF Jacksonville employees, the Office of Research Affairs Training Portal provides web-based access to trainings specific to employees’ research related roles and responsibilities, while improving the real-time analysis and tracking of research training activities. The Training Portal takes approximately two minutes to complete. Upon completion, the employee will receive emails containing access to their required and comprehensive trainings. If you have any questions, please contact the Office of Research Affairs at (904) 244-9478. Office of Research Affairs Training Portal Office of Research Affairs Resource Manual The purpose of the research manual is to provide guidance and instruction for research related activities conducted at University of Florida - Jacksonville, UF Health Jacksonville and UF Jacksonville Physicians, Inc (to be referred to as UF-Jax). The policies and procedures in this research manual encompass virtually all administrative aspects of preparing, conducting, and closing research projects. It also includes ready access to all of the forms and other required documentation as well as a wealth of other information, such as myUFL resources and required training, links to fee schedules and contact information. Active Enrollment Clinical Trial Portal The Active Enrollment Clinical Trial Portal is a tool designed for departmental research staff to provide information on all clinical trials actively enrolling patients at University of Florida College of Medicine – Jacksonville. The purpose of the "Active Enrollment Clinical Trial Portal" is to ensure all recruitment efforts are utilized by making the study information available on Departmental websites, the principal investigator's profile page, and the UF College of Medicine – Jacksonville Clinical Trial Search Page. Please provide information at the Active Enrollment Clinical Trial Portal. When a study is submitted through the portal, the Office of Research Affairs Regulatory Manager will review and work with the submitter to finalize the study information. Once finalized, the study information will be published on the department’s website, the principal investigator’s profile page, and the UF College of Medicine – Jacksonville Clinical Trial Search Page. Checklist for Clinical Study Agreements (CTA Checklist) The Checklist for Clinical Study Agreements (CTA Checklist) is an Office of Research Affairs document required for UF-JAX human subject clinical research that is in the early stages of communication with the study sponsor. The CTA Checklist assists the Office of Research Affairs with contract negotiations, initiates the study build in OnCore, and promotes compliance with all UF policies and applicable state and federal guidelines. To begin working on your CTA Checklist, please click on the link above. Once the CTA Checklist is complete you will receive an email. Please attach the completed (pdf) CTA Checklist to the corresponding study-specific UFIRST Agreement. Informed Consent (IC) Financial Language Assessment (FLA)- CRO-JAX FLA Form The Informed Consent (IC) Financial Language Assessment form (FLA) or CRO-JAX FLA is used to ensure consistency in the financial language found in (1) a Human Subjects Research study’s Informed Consent Form (ICF), and (2) any applicable contract/award/agreement budget and billing plan. In addition, the CRO-JAX FLA will: Provide the study team with UF-approved Costs and Subject Injury language for the study’s Informed Consent Form. Help ensure that study participants are properly informed regarding the study Costs and Subject Injury coverage before they consent to join a study. Decrease the need for changes/corrections to the Informed Consent Form after patients have already enrolled. Minimize the possibility of billing non-compliance by ensuring that the study’s billing plan conforms to research billing regulations. CRO-JAX FLA The Office of Research Affairs (DSP-JAX) is required to approve the ICF Financial Language Assessment (FLA) to ensure the Informed Consent Form (ICF) cost, payment, and injury reimbursement language is consistent with the applicable finalized/negotiated CTA and Budget terms. (It is not required for the CTA to be fully executed before ICF/FLA review begins.) DSP-Jax signed CRO-JAX FLA form * must be included with all new IRB submissions. It is the department’s responsibility to red-line the ICF template in accordance with UF's IRB policy. The red-lined ICF/FLA terms must be consistent with the completed CRO-JAX FLA Form, the UF Cover Sheet and the applicable finalized/negotiated CTA/Budget terms. The department must send the red-lined ICF and the completed CRO-Jax FLA Form to ORA/DSP-JAX for FLA review before the ICF is reviewed/approved by sponsor. Upon sponsor approval of UF's ICF/FLA terms, DSP-JAX will return a signed CRO-JAX FLA Form to the department so it may be included with their IRB submission. Medicare Qualifying Studies The Medicare Qualifying Studies Form* (CMS Billing Verification Form) is a required tool to verify if trial is Medicare qualifying. This form must be completed and signed by ORA prior to study entered into EPIC research module. Please access the link for instructions on the submission and approval processes. Research Study Initiation Request Form In order to determine costs for various clinical trial budget line items, the PI or their research administrator must prepare the Research Study Initiation Request Form* (RSIRF). The final request must be completed and approved prior to enrolling patients. The RSIRF form is required regardless of sponsor (industry, federal government, foundation, state). Please access the link for instructions on the submission and approval processes. OnCore Clinical Research Management System OnCore is a web based Clinical Research Management System that integrates with EPIC and serves as a single, centralized tool for managing multiple aspects of a clinical trial. For example, OnCore is used for protocol management, regulatory assistance, study calendar management, enrollment and visit tracking, financials and billing, reporting and auditing. It ensures financial management, data integrity, compliance and provides consistent and customized reporting features. For the UF College of Medicine-Jacksonville campus, OnCore is managed through a collaborated effort between the Office of Research Affairs and the Office of Clinical Research in Gainesville. If your department is not using OnCore, and need to begin the onboarding process please submit an ORA Portal request. Learn more about our OnCore training OnCore training courses Login to OnCore Office of Research Affairs Internship Portal The Office of Research Affairs Internship Portal is for individuals interested in an unpaid position at the University of Florida College of Medicine – Jacksonville. The portal is designed to collect important information about the potential volunteer/intern to better understand where they are in their career path and what areas of research they are interested in exploring. For University of Florida College of Medicine – Jacksonville Study Teams: If you have a need for additional personnel to assist in at least one project, please complete the Intern Request Form (Intranet) *. Once completed, ORA staff will work with you and your study team to connect you with a qualified intern candidate. The following request forms takes less than five minutes to complete. If you have any questions or require further assistance, please contact the Office of Research Affairs at ora@jax.ufl.edu. Office of Research Affairs Internship Portal Request Form Volunteer to Request to Observe Patient Care Record of Volunteer Service UFCOM-J Request to Observe Patient Care Office of Sponsored Programs The University of Florida Office of Sponsored Programs offers a full range of financial, information and administrative assistance for identifying, obtaining and administering external research funding. Grant Opportunities Sign up to get information about grants available through UF. Research Related Policies and Standard Operating Procedures UF Policy Destroying Expired Kits Instructions for Volunteering Instructions for Student Internships Recorded Trainings Industry Sponsored Clinical Trial Agreement Trainings * Non-Disclosure Agreement Trainings * Contact If you have questions, feel free to contact the Office of Research Affairs at (904) 244-9478 or email ora@jax.ufl.edu. * Please note that this resource can only be accessed from a computer on the UF Health Jacksonville campus or by utilizing the employee VPN. If you have any questions or require further assistance, please contact the Office of Research Affairs at (904) 244-9478.