Legal and IRB Matrix

The Clinical & Translational Research Informatics (CTRI) team provides various tools and services to identify cohorts, perform data extracts, and electronic data capture for studies from the Clinical Research Data Warehouse (CRDW).

The Clinical & Translational Research Informatics Data Warehouse (CTRI-CRDW) has been granted IRB approval to act as a data bank for the Medical College of Wisconsin, providing an honest broker approach to disseminating data in both an de-identifed and identified fashion to Medical College of Wisconsin researchers. This is done by providing an environment that is centrally monitored by the MCW and F&CH IRB, and the MCW and F&CH Legal and Compliance departments.

Some of the tools provided the Clinical Research Informatics team do not require IRB involvement such as the de-identified i2b2 Cohort Discovery tool. Others such as identified extracts do require IRB involvement.

This chart should help you navigate the required agreements, training and certifications required.

Tool or Service	IRB Approval	Agreements	Citi Training	Security Training
Using i2b2 de-identified tool	None	You are required to complete the i2b2 Cohort Tool Access agreement.	Required	None
Obtaining a de-identified data extract from i2b2	None	You are required to complete the Data Use Agreement.	Required	Required
Obtaining an identified data extract from i2b2	You are required to contact the IRB	You are required to complete the Data Use Agreement.	Required	Required
Using REDCap to store data with PHI	You are required to contact the IRB	None	Required	Required
Using a custom CTRI solution to store PHI	You are required to contact the IRB	None	Required	Required
Using OnCore	See the Cancer Center Clinical Trials Office	See the Cancer Center Clinical Trials Office	See the Cancer Center Clinical Trials Office	See the Cancer Center Clinical Trials Office

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Legal and IRB Matrix

Legal and IRB Matrix