On behalf of Carl I. Schulman, MD, PhD, MSPH, FACS
Executive Dean for Research
Dear Research Community,
In order to facilitate the approval process for clinical studies submitted to our partners at Jackson Health Systems (JHS), we are pleased to announce new tools to guide University of Miami (UM) investigators planning to conduct research activities at JHS.
Effective September 15th, the following forms and processes are being implemented
- Information Sheet for UM Investigators, Jackson Health System (JHS) Clinical Trials Office (CTO) and Clinical Research Review Committee (CRRC) Approval Process (click here)
Approval from the JHS-CRRC must be obtained for studies with any research activities (including recruitment of subjects, facilities use, or subject interventions such as tests, measurements, drug administration, surgery, or consenting subjects) occurring at a JHS facility or any studies that involve accessing JHS patient information prior to the use of any JHS resources.
In order to avoid delays on approvals, complete the JHS CTO Application, required JHS forms (see section JHS CTO), and work with the JHS CTO and JHS IT (if applicable) while waiting for IRB approval.
If assistance is needed to complete the JHS application or any JHS forms, contact JHS CTO inbox: JHS-CTO-Submissions@jhsmiami.org
Additional information can be found at Engaging Clinical Research
- PHT-UM Data Exchange Form (DEF) (click here)
A DEF must be submitted for studies with any research activities (including recruitment of subjects, facilities use, or subject interventions such as tests, measurements, drug administration, surgery, or consenting subjects) occurring at a JHS facility, or for studies that involve accessing JHS patient information prior to the use of any JHS resources.
The completed DEF (including the list of data variables) and CRF’s should be submitted to medresearch@miami.edu The PHT-UM Data Exchange Form (DEF) can be accessed click here. and an example of requested variables can be found here.
Sincerely,
Office of the Executive Dean for Research (EDR)
Jackson Health System (JHS) Clinical Trials Office (CTO) and Clinical Research Review Committee (CRRC)
