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. If you have any questions please contact the Director, Anderson Brabson at email@example.com
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 firstname.lastname@example.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 Laini Waters at email@example.com. All forms can be found below.
The remaining submission dates for 2018 are:
March 9 (submission deadline February 20)
April 13 (submission deadline March 27)
May 11 (submission deadline April 24)
Study Related Forms and Checklists
Documentation of Consent
Humanitarian Device Exemption (HDE) Checklist Local Coverage Determination (LCD) Checklist
TGH Emergency Use Checklist
USF IRB Checklist
TGH Study Application
TGH Emergency Use Form (Emergency or Compassionate Use)
Example of completed TGH application
Research Information Sheets
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.
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.
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 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 firstname.lastname@example.org within 24 hours of the SAE.
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.