We are excited you are pursuing research at Tampa General Hospital! Every day, researchers affiliated with Tampa General Hospital investigate new treatment opportunities for patients and discover new ways to advance the science that leads to evidence-based health care at a world-class level.
To assist in this essential component of our leading academic medical center, Tampa General offers a variety of resources available to research professionals.
Please review the Investigator Manual for more information, policies and procedures related to research at TGH.
Standard Study Submission Process
To submit a research study, ALL RESEARCHERS must email all appropriate, required documents to firstname.lastname@example.org.
The required documents are:
Informed Consent Forms
Data Collection Forms
FDA Approval Letter (Investigational Drug and Device Studies)
Investigator Brochure (Investigational Drug Studies)
Instructions for Use (Investigational Device Studies)
Device Manual (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 email@example.com. The supplementary TGH feasibility forms are:
Investigational Pharmacy Services Only Expedited Submission Process
To submit a research study that is ONLY utilizing Investigational Pharmacy Services at TGH, Complete the Abbreviated Research Study Proposal Form and email it along with the other required documents listed below to firstname.lastname@example.org. The OCR will then review the study on an expedited basis.
The required documents are:
- Abbreviated TGH Research Study Proposal Form for Use of Investigational Pharmacy Services Only
- Study Protocol
- PI CV
- Informed Consent Form
- Investigator Brochure
- TGH Drug Information Sheet
- FDA IND Approval Letter
- Pharmacy Manual
Clinical Laboratory Services Only
If your study is ONLY utilizing TGH for Clinical Laboratory Services, it may be eligible for an expedited process instead of the Standard Study Submission Process above. Please answer the questions below and email your answers to email@example.com. Further instructions will be provided by the OCR.
- Where are the labs being drawn, at a TGH facility or somewhere else? (if you are unsure if the location you have in mind is a TGH facility, view all TGH locations)
- Who is drawing the labs, a TGH employee or someone else?
Approval Process for Research
All research conducted at TGH, regardless of the investigator, must meet the same criteria for approval. (1) IRB approval (2) TGH OCR approval. TGH recognizes several IRB’s; however, our local IRB is the University of South Florida. Individuals who are not using one of the IRB’s that we recognize will need to submit an application to USF IRB. If the study is being conducted to meet educational requirements, the student’s school may require approval by their IRB as well as USF.
USF IRB – TGH Affiliate Approval
Effective October 10, 2018, for any study requesting TGH affiliate approval within the 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
All researchers must be credentialed to conduct or participate in research at Tampa General Hospital. You may submit your study for approval while completing the credentialing process. For more information, refer to the Credentialing section.
TGH Protocol And Informed Consent Form (ICF) Templates
TGH OCR will review all ICFs to ensure the TGH HIPAA authorization language and subject injury language are inserted. If your study requires the use of informed consent, the TGH ICF template may be used. If you are using the University of South Florida (USF) Institutional Review Board (IRB) for study oversight, please refer to their website for guidance.
TGH Investigational Pharmacy Introduction
For more information about TGH’s Investigational Pharmacy, please review the TGH IDS Information and Pharmacy Tour document. This document can be provided to Sponsors/Contract Research Organizations (CROs) if they seek more information about the Investigational Pharmacy.