For Researchers

To submit a research study, ALL RESEARCHERS must email all appropriate, required documents to research@tgh.org.

The required documents are:

• Research Study Proposal Form (RSPF)
• Study Protocol
• Study Budget
• IRB Application
• Informed Consent Forms
• Data Collection Forms
• Contractual Agreements
• FDA Approval Letter (Investigational Drug and Device Studies)
• Investigator Brochure (Investigational Drug Studies)
• TGH Drug Research Information Sheet (Investigational Drug Studies)
• Instructions for Use (Investigational Device Studies)
• Device Manual (Investigational Device Studies)
• TGH Device Research Information Sheet (Investigational Device Studies)
• Additional Documents as Appropriate

The OCR will review the study documents and may contact you to ask questions about how you plan to operationalize the study.

There are supplementary forms for studies impacting TGH departments/units or using any TGH services. These forms are not required for initial submission; however, the OCR recommends submission of the appropriate supplementary forms to expedite turnaround for study approval. If you are uncertain, please contact us at research@tgh.org.

The supplementary TGH feasibility forms are:

• TGH Unit Operational Review of Proposed Research
• TGH Imaging Feasibility Form (TGH main hospital and TGH Outpatient Center)
• Technology Operational Review of Proposed Research
• TGH Outpatient Imaging Intake Form

To submit a research study that is ONLY utilizing Investigational Pharmacy Services at TGH, complete the Abbreviated Research Study Proposal Form and email it along with the other required documents listed below to research@tgh.org. The OCR will then review the study on an expedited basis.

The required documents are:

• Abbreviated TGH Research Study Proposal Form for Use of Investigational Pharmacy Services Only
• Study Protocol
• PI CV
• Informed Consent Form
• Investigator Brochure
• TGH Drug Information Sheet
• FDA IND Approval Letter
• Pharmacy Manual

If your study is ONLY utilizing TGH for Clinical Laboratory Services, it may be eligible for an expedited process instead of the Standard Study Submission Process above. Please answer the questions below and email your answers to research@tgh.org. Further instructions will be provided by the OCR.

• Where are the labs being drawn, at a TGH facility or somewhere else? (if you are unsure if the location you have in mind is a TGH facility, view all TGH locations)
• Who is drawing the labs, a TGH employee or someone else?

All research conducted at TGH, regardless of the investigator, must meet the same criteria for approval. (1) IRB approval (2) TGH OCR approval. TGH recognizes several IRB’s; however, our local IRB is the University of South Florida. Individuals who are not using one of the IRB’s that we recognize will need to submit an application to USF IRB. If the study is being conducted to meet educational requirements, the student’s school may require approval by their IRB as well as USF.

USF IRB – TGH Affiliate Approval

Effective October 10, 2018, for any study requesting TGH affiliate approval within the USF BullsIRB system, the affiliate approval process will proceed as follows:

• Studies will be reviewed at TGH and provided approval to proceed to IRB via the eIRB.

• Once a study is USF IRB approved, the study submitter must submit all IRB approved documents to research@tgh.org

• TGH will re-review the study and provide a TGH institutional approval letter.

• Research may not commence at TGH until a TGH OCR Final Approval Letter is granted

All researchers must be credentialed to conduct or participate in research at Tampa General Hospital. You may submit your study for approval while completing the credentialing process. For more information, visit our Credentialing page.

TGH OCR will review all ICFs to ensure the TGH HIPAA authorization language and subject injury language are inserted. If your study requires the use of informed consent, the TGH ICF template may be used. If you are using the University of South Florida (USF) Institutional Review Board (IRB) for study oversight, please refer to their website for guidance.

• TGH Protocol Template: Biomedical
• TGH Protocol Template: Social Behavior
• TGH Protocol Template: Chart Reviews
• TGH Specific Protocol Supplement
• TGH Informed Consent Template: General
• TGH Informed Consent Template: Compassionate Use
• TGH Informed Consent Template: Survey Research
• TGH ICF Instructions

For more information about TGH’s Investigational Pharmacy, please review the TGH IDS Information and Pharmacy Tour document. This document can be provided to Sponsors/Contract Research Organizations (CROs) if they seek more information about the Investigational Pharmacy.