Share on Facebook Share on Twitter Share on Google Plus Share on Pinterest Share on Linkedin

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 credentialing is handled by the Office of Clinical Research.  All other credentialing applications are handled through the Human Resources Department. Please contact Laini Waters at lwaters@tgh.org for your credentialing packet.

After you have received the appropriate credentials you must submit your study to the OCR. Please submit all appropriate forms and documents to research@tgh.org. All forms can be found below.

Study Related Forms and Checklists

TGH Applications

Research Information Sheets

Research Info Sheet for Device/Procedure Studies  
Research Info Sheet for Drug Studies  

IRB Forms and Templates

If your study requires use of an informed consent, please select one of the templates below to use for your study submission. Click here for the required elements of informed consent.

Emergency Use 

TGH Required ICF Language

Tampa General Hospital has specific language that must be included in all research informed consent forms for studies taking place at the hospital. The required injury and HIPAA language should be included in all Informed Consent documents. For any questions regarding the injury language, please contact the Office of Clinical Research.

Injury Statements

Greenphire – If a stipend is paid by with a ClinCard, the following language needs to be inserted into the Cost section of the ICF. “A company called ‘Greenphire’ will manage travel reimbursement and a ClinCard, which is a debit card, will be provided to you. When you complete a visit, the amount outlined in this Informed Consent Form will be automatically approved and added onto your ClinCard. The study staff will provide you with additional information about how the ClinCard works. In order for Greenphire to be able to reimburse you using the ClinCard, Greenphire will collect the following information about you: your social security number (required), your name (required), birth date (required), address (required), and contact details (cell phone number and/or email address – optional). By choosing to use the ClinCard service you are authorizing the release of this information to Greenphire.”

Study Management Forms

The Office of Clinical Research (OCR) at TGH requires notification of all patients enrolled in or participating in research at the hospital. The patient status update in the MERGE Clinical Trial Management System (MERGE) and the scanning of the consent form must be completed within 24 hours of enrollment.  Please call the OCR manager at 813-844-4211 for any questions related to MERGE or to request access.

The TGH OCR requires notification within 24 hours of all research related clinical services at TGH that will be paid by the study sponsor. All patient visits and procedures must be updated in MERGE within 24 hours. For device studies, the information must be updated in MERGE 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 research@tgh.org within 24 hours of the SAE.

Serious Adverse Event Reporting Form 

Additional TGH Forms

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.

    EPIC Forms