|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.
|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
|Limited Data Set||Data Use Agreement
Required by the U.S. code of federal regulations, Principal Investigators (PIs) sign on behalf of study team
|Protected Health Information (PHI)||Data Agreement
Required by Regenstrief Institute, PIs sign on behalf of study team
*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).