WE ARE EXCITED THAT YOU ARE PURSUING RESEARCH AT TAMPA GENERAL HOSPITAL!
TGH OCR has transitioned to an online Research Study Proposal Form! To submit a research study, complete the Research Study Proposal Form below. TGH OCR requires that current available versions of the study documents be attached to the Research Study Proposal Form. TGH OCR is aware that not all documents may be available at the time of submission. Submitters should always reference this website to obtain the correct documents prior to submission. If you have any questions or concerns, please contact email@example.com.
Access the online research study proposal form by clicking the link below.
Documents to Submit (If Available)
- Study Protocol (Required)
- 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)
- TGH Unit Operational Review of Proposed Research
- Additional Documents as Appropriate
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 ¨C 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 firstname.lastname@example.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.