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Study Submission

The Office of Clinical Research (OCR) is here to provide physicians and study teams with resources and information on how to conduct research at TGH.

The OCR recognizes that the clinical research environment is fluid and we anticipate our services to evolve to meet the needs of our clinical research colleagues. Please visit our site often and contact our office directly for information on how we can meet your individual requests. 

The first step is to make sure you have completed the TGH research credentialing process.  All student and TGH staff  research  credentialing is handled by the Office of Clinical Research.  For more information, refer to the CREDENTIALING section.

To submit a research study, utilize the appropriate forms and documents below. Send the completed research proposal package to research@tgh.org.

As of November 13, 2018, TGH has a new submission process.  There will be a grace period in which TGH will accept outdated TGH applications.  This grace period will end on December 31, 2018. 

Beginning on January 1, 2019 TGH requires that submission packets include the new and most current versions of all documents listed below.  Submitters should always reference this website to obtain the correct documents prior to submission.  Any packets submitted with outdated documents or incomplete packets will be returned and will not be processed.

USF IRB – TGH Affiliate Approval

Effective October 10, 2018 for any study requesting TGH affiliate approval within USF eIRB system, the affiliate approval process will proceed as follows:

  1. Studies will be reviewed at TGH and provided approval to proceed to IRB via the eIRB.
  2. Once a study is USF IRB approved, the study submitter must submit all IRB approved documents to research@tgh.org
  3. TGH will re-review the study and provide a TGH institutional approval letter.

Research may not commence at TGH until a TGH institutional approval letter is granted.

Approvals Required to Start Study Activities 

For all studies conducted at TGH using any TGH resources, data (e.g., medical record information) and/or facilities, two written approvals are required prior to starting the study: 

  1. Institutional Review Board (IRB) approval; and
  2. TGH OCR approval

TGH Research Study Proposal Form

TGH has two (2) research study submission options:

  • Option #1 - PRE-SUBMISSION
    • The PRE-SUBMISSION is a helpful option that allows your study to be reviewed early on in the TGH intake process.  The PRE-SUBMISSION is not mandatory but encouraged. The benefit of this option is to assist in identifying areas and items of clarification that can be addressed early on in the study intake and review process. 
    • Examples of studies applicable to PRE-SUBMISSION Option Include: Drug Studies; Device Studies; Sponsor Studies; Pre-Grant Request; Protocol Development; any studies with a contract, budget and/or informed consent.
  • Option #2- COMPLETE SUBMISSION
    • The COMPLETE SUBMISSION is required for all studies and must include all documents outlined in TGH Research Study Proposal Form.
    • Examples of studies that must go directly to the COMPLETE SUBMISSION Option Include: Retrospective Chart Review; Quality Improvement Studies; or any study with NO informed consent, budget and/or contract.
    • Studies submitted under Option #1 must proceed to Option #2, Complete Submission, once all study documents are available.
For emergency use or compassionate use studies, please contact research@tgh.org for further directions.

Research Information Sheets

TGH Drug Research Information Sheet  
TGH Device/Procedure Research Information Sheet  

TGH Unit Awareness & Support 

  1. Studies that involve TGH inpatient/outpatient units and/or departments or require TGH bedside nursing support and/or ancillary support: an assessment must be completed. Submit the following documents:   
  1. Nursing Research Study (Principal Investigator is a Nurse):  All nursing research studies must be submitted to Mary Kutash, TGH Advanced Nurse Research Specialist (mkutash@tgh.org).  Submit the following:    
  • Study documents (e.g. Chart Review Studies)

OR

You may submit the TGH Research Study Proposal Form with or without the TGH Unit Awareness & Support documentation at initial submission; however, all required documents are needed to proceed through the TGH review and approval process.

TGH Informed Consent Form (ICF) Template

TGH OCR will review all ICFs and add TGH HIPAA authorization language and subject injury language. If your study requires use of an informed consent, the TGH ICF template may be used. If you are using University of South Florida (USF) Institutional Review Board (IRB) for study oversight, please refer to their website for guidance.
TGH OCR will review all ICFs and add TGH HIPAA authorization language and subject injury language.