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 email@example.com 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.
Please contact firstname.lastname@example.org with any questions.