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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  There will be a grace period in which TGH will accept outdated TGH applications.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  Any packets submitted with outdated documents or incomplete packets will be returned and will not be processed.

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.

Research Study Proposal

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  

Nursing Feasibility and Support Letters

Nursing support letter for clinical research studies:
Nursing support letter for nursing studies:

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.
TGH OCR will review all ICFs and add TGH HIPAA authorization language and subject injury language.