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 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

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 research@tgh.org with any questions.