When submitting a new protocol for review to the TGH Office of Clinical Research (OCR), you should first determine what type of study you will be conducting.
Please click on the study type for more information and to download the appropriate forms:
- Exempt (chart reviews)
- Expedited (minimal risk, observational, prospective survey, etc.)
- Emergency Use
- Humanitarian Device Exemption
- Prospective Study
Informed Consent Templates
If your study requires use of an informed consent, please select one of the templates below to use for your study submission. Click here for the required elements of informed consent.
Tampa General Hospital has specific injury statements that need to be included in all research informed consents for studies taking place at the hospital. These statements should be included in all Informed Consent documents.
- Adult Injury Statement
- Child Injury Statement
- Spanish Adult Injury Statement
- Spanish Child Injury Statement
The OCR at TGH requires notification of all patients enrolled in or participating in research at the hospital. The OCR must review this notification within 24 hours of enrollment via fax, hand-delivery or email to email@example.com. (download form)
The OCR at TGH requires notification of all clinical services rendered to research subjects at TGH that will be paid by the study sponsor within 24 hours of treatment. The OCR must receive this notification within 24 hours of treatment via fax, hand-delivery or email to firstname.lastname@example.org . For device studies, the OCR must receive the billing notification prior to on the day of the implant at the latest.
Adverse Event Reporting (Download Form )
The OCR at TGH requires the reporting of all study-related, TGH impatient adverse events, serious adverse events, and unanticipated adverse events in research subjects enrolled in all approved studies. The following form should be sent to OCR via fax, hand-delivery or email to email@example.com within 24 hours of the AE.
Documentation of Informed Consent (Download Form )
Additional TGH Forms
Financial Disclosure Form (complete if necessary)