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 email@example.com.
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 firstname.lastname@example.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 email@example.com before the study is activated. For your convenience, the submission form can be found here.
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.
TGH Informed Consent Form (ICF) Template
TGH OCR will review all ICFs and add TGH HIPAA authorization language and subject injury language. If your study requires use of an informed consent, the TGH ICF template may be used. If you are using 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: Compassionate Use