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Office of Research College of Medicine

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FORMS & TEMPLATES

CRH STUDY SUBMISSION FORMS

Always download and save the latest version of any form or resource from this website before compiling study documents.

BILLING GRID Version 09/14/2023

QC OnCore Calendar Checklist (Click to download) Version 05/26/21

Schedule of Events / Treatment Arm Details Template (Click to download)

All protocols that require an OnCore calendar need to have a Schedule of Events (SOE) that is in the form of a table listing the study visits as a timeline, and the procedures and events associated with each visit. If the protocol does not list the SOE in a table, this template must be used to provide one for during the OCR Intake process.

Drug Table Version 09/13/2023

Used to document all specifically-named drugs, biologics, nutritional supplements, or any other ingested/applied substances required by the study protocol.

DEVICE TABLE Version 04/25/2024

The Device Table documents all specifically-named, non-generic medical devices (investigational or non-investigational) required by the protocol. It is used by the Clinical Research Hub to help identify research billing and contractual risks associated with the use of protocol-required devices in research. Please note that the device table is NOT shared with the IRB or FDA.

DEVICE TABLE INSTRUCTIONS

On the Device Table, double click the grey boxes to access the drop-down options. If any of your drop-down selections has a single * or double asterisk **, carefully read and follow the associated guidance at the bottom of the form. This is especially important if your study billing plan includes billing patients/insurance in an IDE or CAS study as well as sponsor provided devices that are being provided at no charge.  

1) In the header, type in the Study Nickname (i.e. the name your study team uses to reference this protocol).

2) For each device, enter or select the

  • Name/Description of the device as it is referenced in the protocol
  • FDA Device Type (select from drop-down).
  • FDA # (for IDE or CAS Devices Only) – Confirm with FDA letter
  • Funding Source (select from drop-down)
  • Location of Device Use (select from drop-down and specify details in comments)
  • Does Shands Need to Purchase/Receive?
  • Storage Location (select from drop-down)

3) Please enter any information in the comments section that would provide clarity to any specifics related to this device/form.

OTHER FORMS & TEMPLATES

RESEARCH ORDER FORMS

As of 2020, study teams should be entering all UF Health research orders into Epic. In ADDITION to Epic orders, the following service areas still require paper research forms:

TRACKING LOG TEMPLATE FOR STUDY-FUNDED SERVICES – R99 Tracking Log Template (legacy studies only)

DEVICE STUDY MEDICARE PRE-APPROVAL FORMS – FCSO IDE Approval Submission Form (legacy studies only)

  • CASE MANAGEMENT – (Participant’s Insurance Coverage Determination): Call 352-265-0477

OTHER CLINICAL RESEARCH RESOURCES