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Please provide any feedback regarding Scenario #1 in the comment form below or by clicking here. |
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Max Researcher at Advanced Research Institute wants to conduct a study on drug safety for cardiac conditions that will require combining clinical and claims data to create an aggregated data set of complete records for individual patients. This will be secondary analysis and will not require any new data collection. Max will work with a Coordinating Center to access the data.
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The Research Information System combines the data such that Max Researcher can accomplish the goals of the protocol for the Human Nature study.
Title | Response |
Description | At the request of the researcher, data sets stored by a variety of data sites are aggregated for the purpose of supporting an approved data analysis protocol for a research study. |
Primary actor/participant | Researcher (end-user) using Research Info System |
Support actor/participant | Coordinating Center System, Data Site (Datamart) System |
Preconditions |
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Postconditions |
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Alternatives |
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Considerations | Researchers must access multiple, separate portals to obtain data to be linked. |
Data Elements Considered | Electronic data from multiple sites |
Purpose of the Data Collection | Clinical care, administrative purposes |
Purpose of Data Use | Analysis under a specific research protocol |
Terms of Transfer to the Data Holders | Usual care, Notice of Privacy Practices |
Terms of Transfer to Researchers | IRB approval |
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