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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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- It correlates with patient research unique identifiers supplied in the request with data-site-specific identifiers for each intended data site and it identifies four sites that store relevant data sets.
- The Coordinating Center System adds technical criteria corresponding to the approved data set to be supplied by each site.
- It submits separate requests to each of four data sites.
- Each data site receives a list of patients using the site local identifier and returns the matching set of records defined in the Data the Data Use Agreement.
- The Coordinating Center System processes the responses (success/failure) and the data returned from each data site and returns the data sets to Advanced Research Institute system (Research Information System)
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 |
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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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