Data Types, Agreements, and Hand-off

Data Types, Agreements, and Hand-off2018-10-24T10:37:31-04:00
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).

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