Submit a New Study to WCG


I.     Complete a UF Cover Letter

All submissions from UF and UF Health (aka Shands) researchers to WCG must include a copy of our new web-based UF Cover Letter.  Completion of this online form will email you a document that you download, sign, and include in your submission to WCG.  You must include the new UF Cover Letter with your submission to WCG to ensure:

A. that the paperwork approved by WCG complies with UF specific requirements. For example- UF requires certain language in the Informed Consent form that WCG does not necessarily require in consent forms for other institutions. Of considerable importance is that the Consent includes our relevant local language.

B. that UF and its research related offices are properly notified about the status of your research.  For example, the new UF Cover Letter includes an institutional number that enables us to sync WCG data (eg approval date) with UF systems.

Failure to complete and include our UF Cover Letter can result in compliance issues for you later, the least of which may be having to revise your paperwork and resubmit to WCG (which will obviously include a fee).

NOTE 1: Sometimes sponsors complete the paperwork and submit it to WCG on your behalf. It is incumbent upon you, the PI, to insure that the UF Cover Letter is included with the submission. The administration is not likely to absolve you in a compliance situation if your excuse is “the sponsor submitted it for me”.

NOTE 2: DEVICE TRIALS: Since UF Health is responsible for acquiring, storing, and billing for devices researchers must contact UF Health prior to submitting to WCG in order to facilitate the hospital’s acquisition and compliant billing of the devices. UF Health’s Research Billing Office (RBO) must authorize device trials before implementation.  For more information visit

Gainesville: or email

Jacksonville: UF Health/Jacksonville Supply Chain Services at (904) 244-4227 and/or the Value Analysis Facilitator at (904) 244-4524.

 II.  Informed consent templates

Informed consent forms must contain UF approved template language.  Please review the requirements at

NOTE 1: WCG or your sponsor may have their own version of the consent. You will use either template and edit the relevant portions consistent with your answers on the UF Cover Sheet.

NOTE 2: If WCG or your sponsor writes your informed consent for you, it is still your responsibility to ensure that the approved consent form has the relevant UF language.

NOTE 3: Please note that informed consent requirements regarding local language apply to all consents (including pregnant partners).

NOTE 4 IMPORTANT: effective June 2024 (announcement), UF’s longstanding FLA process to determine the cost language for informed consents has been discontinued.  Going forward, researchers pick one of four approved cost templates to put in the informed consent form.  Please review the workflow diagram of the new process.  In order to enroll subjects, researchers must get an IRB approved consent form AND CRH/ORA activation.

III.  Submit your study to CRH or Jax ORA

Before you can enroll any subjects on a clinical trial you must not only obtain IRB approval, but also have your study activated by either:

These offices work with researchers to ensure budgets, billing, and cost language is appropriate in informed consent forms.  CRH/ORA review is independent of IRB review – you can initiate either first or simultaneously.

IV.   Submit to HURRC (if applicable)

Research involving exposure of humans to ionizing radiation requires additional specific approval from the Human Radioisotope and Radiation Use Committee (HURRC). For HURRC process please see

Contact: Jason Timm (392-7359) via e-mail at

VI.  Submit to the Investigational Drug Service (IDS) / Pharmacy (if applicable)

If your protocol involves drugs, biologics, or other agents you must complete both of the following steps:

A. Submit a copy of the sponsor’s protocol and Investigator Brochure (if available) to the UF Health Investigational Drug Service Pharmacy prior to submitting the study to WCG. You may submit by email to the following address: or by campus mail to: HSC Investigational Drug Service Pharmacy, Box 100316, Gainesville, FL 32610-0316.  Please include current protocol, Investigator Brochure, and Pharmacy Manual (if available).

B. When submitting your new study to WCG, please add as a contact within the initial submission form. This will ensure that IDS is automatically notified of all of the approvals for your project: Initial, Continuing Review, as well as other amendments. Failure to add IDS as a contact may result in your project/treatment being delayed while pharmacy verifies project or revision approvals. Further, if IDS is unaware of updated approvals or documentation, dispensing may occur on outdated information leading to protocol deviations and/or risks to patient safety.

VII.     Obtain Institutional Biosafety Committee Review (if applicable)

If your study involves Human Gene Therapy, you MUST

A. Notify Michael Mahoney at (352) 294-2744 prior to submitting the study to WCG.

B. Submit a copy of your project to the Institutional Biosafety Committee (IBC) at UF. You may not use the IBC at WCG. A project that needs IBC review cannot begin until it has the approval of both the UF IBC and IRB. Click here IBC Cover Letter for additional information about submitting paperwork to the UF IBC. For more information, contact UF IBC, Box 112190, UF, Gainesville, FL 32611.

VII.   Submit to WCG

Working with WCG Brown Bag Slides, presented by Jacob Johnson, July 22, 2020