Data Type | Required Documentation | Approved Storage Method |
Aggregate level counts | Request for Review Preparatory to Research Required by Regenstrief Institute and managed by Indiana CTSI’s Feasibility Request Form. Feasibility Template |
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De-identified data at a patient-specific level | Terms of Access Required by Regenstrief Institute, include a copy of the TOA to the study team, no signature needed TOA template Data Request Form |
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Limited Data Set | Data Use Agreement Required by the U.S. code of federal regulations, Principal Investigators (PIs) sign on behalf of study team Data Request Form Data Dictionary Template |
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Protected Health Information (PHI) | Data Agreement Required by Regenstrief Institute, PIs sign on behalf of study team Data Request Form Data Dictionary Template |
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*Slashtmp Critical can also be used to send protected health information (PHI) to the Data Core (e.g. a patient list).
**An institution and/or department may have its own HIPAA approved internal server for data storage (e.g. Regenstrief Institute, Indiana CTSI ResNet, or Indiana CTSI Biostatistics).