WE ARE EXCITED THAT YOU ARE PURSUING RESEARCH AT TAMPA GENERAL HOSPITAL!
Study Submission
To submit a research study, please email all appropriate documents to research@tgh.org.
The required documents are:
- OCR Submission Form
- 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 Operational Review of Proposed Research
- Technology Operational Review of Proposed Research
Note: An abbreviated form is available for retrospective chart review studies with no informed consent, budget, contract, and/or Tampa General Hospital billable procedures or services. Additionally, these types of studies must be submitted to research@tgh.org before the study is activated. For your convenience, the submission form can be found here.
Credentialing
Researchers must be credentialed by the Office of Clinical Research to do research. You may submit your study for approval while completing the credentialing process. For more information, refer to the Credentialing section.
USF Protocol and Informed Consent Templates
TGH OCR will review all ICFs and add TGH HIPAA authorization language and subject injury language. If you are using University of South Florida (USF) Institutional Review Board (IRB) for study oversight, please refer to their website for guidance.
USF IRB – TGH Affiliate Approval
Effective October 10, 2018 for any study requesting TGH affiliate approval within 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.