For Researchers | TGH Office of Clinical Research

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 health system, 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

Required Documents

To submit a research study, ALL RESEARCHERS must email all appropriate, required documents to

The required documents are:

The OCR will review the study documents and may contact you to ask questions about how you plan to operationalize the study.

Supplementary Forms

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

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 The OCR will then review the study on an expedited basis.

The required documents are:

Clinical Laboratory Services Only - Expedited Submission Process

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 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

  • 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, visit our Credentialing page.

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

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.

Study Management

The Office of Clinical Research (OCR) at TGH requires notification of all patients enrolled in or participating in research at any TGH location. The patient & status must be kept current in the EPIC & Clinical Trial Management System (CTMS).  The informed consent form must be scanned into EPIC within 24 hours of enrollment. 

The TGH OCR requires notification within 24 hours of all research related clinical services at TGH. All patient visits and procedures must be updated in CTMS within 24 hours. For device studies, the information must be updated in CTMS on the day of the implant.

The TGH OCR requires the reporting of all study-related, TGH inpatient serious adverse events  (SAEs) for research subjects enrolled in all approved studies. The following form should be sent to OCR via fax or email to within 24 hours of the SAE.

Serious Adverse Event Reporting Form 


Financial Disclosure Form   – This form is to be completed if PI or key personnel has a financial interest in the study or with the study sponsor.


Tip sheet for research coordinators  
EPIC Access Request for Monitors 
Visit cover sheet 
Information sheet cover sheet 
Consent cover sheet 
EPIC order set 

Please contact with any questions.