TGH Office of Clinical Research
USF Health · Office of Research

Forms

Study Types

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:
  1. Exempt (chart reviews)
  2. Expedited (minimal risk, observational, prospective survey, etc.)
  3. Registry
  4. Emergency Use
  5. Humanitarian Device Exemption
  6. Prospective Study

Injury Statements

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.

  1. Adult Injury Statement
  2. Child Injury Statement
  3. Spanish Adult Injury Statement
  4. Spanish Child Injury Statement

 

Patient Enrollment (Download Form )

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 using the online notification tool. (download form)
 

Patient Billing Notification Form (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 using the online notification tool.

Adverse Event Reporting (Download Form )

The OCR at TGH requires the reporting of unanticipated adverse events and all serious adverse events in research subjects enrolled in all approved studies. The following form should be sent to OCR via fax, hand-delivery or using the online notification tool within 25 hours of the AE.


Additional TGH Forms

  1. Conflict of Interest  (complete if necessary)