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

  • Not applicable. Data analyst will email results to investigator.
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

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

Protected Health Information (PHI) Data Agreement

Required by Regenstrief Institute, PIs sign on behalf of study team

Data Request Form

Data Dictionary Template

*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).