Resources The following resources are in place to assist and support sponsored research at any stage of a clinical trial. For recently hired research coordinators, please review Clinical Research 101 and contact the Clinical Research Office to initiate the next steps required for your role at University of Florida College of Medicine-Jacksonville. The lists below contain web links to the different tools needed during the life of a clinical trial. UF College of Medicine Faculty and Staff Office of Research Affairs Portal (Password protected) Facilities and Administrative (F&A) or Indirect Costs (IDC) Institutional Review Board (IRB) OnCore (Clinical Trial Management System) Financial Conflict of Interest (FCOI) 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. 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. 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. 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. Industry Sponsors Clinical Trials.gov Clinical Trial Science Institute Facilities and Administrative (F&A) or Indirect Costs (IDC) Financial Conflict of Interest (FCOI) Education and Training Office of Research Affairs Training Portal Institutional Review Board Training Participant Payment This section contains documents that are important for you. Please enter the password that was included in your confirmation email. If you have any issues please email email@example.com. Password View Documents and Links Additional Services Clinical and Translational Science Institute EPIC Scientific Committee Review UF clinical trials: Biorepository (Coming Soon) Service facilities (Coming Soon) Pharmacy Pathology Imaging Nursing Cancer Center For more information about the Clinical Research Office at the UF College of Medicine- Jacksonville, email firstname.lastname@example.org.