Legal and IRB Matrix

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 ServiceIRB ApprovalAgreementsCiti TrainingSecurity Training
Using i2b2 de-identified toolNoneYou are required to complete the i2b2 Cohort Tool Access agreement.RequiredNone
Obtaining a de-identified data extract from i2b2NoneYou are required to complete the Data Use Agreement.RequiredRequired
Obtaining an identified data extract from i2b2You are required to contact the IRBYou are required to complete the Data Use Agreement.RequiredRequired
Using REDCap to store data with PHIYou are required to contact the IRBNoneRequiredRequired
Using a custom CTRI solution to store PHIYou are required to contact the IRBNoneRequiredRequired
Using OnCoreSee the Cancer Center Clinical Trials OfficeSee the Cancer Center Clinical Trials OfficeSee the Cancer Center Clinical Trials OfficeSee the Cancer Center Clinical Trials Office