Page History

Max Researcher at Advanced Research Institute obtains approval from the Advanced Research Institute‘s IRB for the Human Nature protocol.

Using the list of approved patients identified by their research unique identifier, Max loads the list into the Research Information System and submits the list in an electronic request to the Coordinating Center. The request specifies the patients enrolled in the protocol using the research unique identifier, assigned by Coordinating Center.

Advanced Research Institute has a Data Use Agreement with a set of Data Sites. The agreement specifies that various data sites (i.e., covered entities) will provide a "minimum data set" of health information to be used in the Human Nature research study (a study containing only data analysis one protocol).

Once the Coordinating Center System receives the request for data sets from Advanced Research Institute (on behalf of Max Researcher), it does the following:

1. It correlates 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.
2. It adds a technical criteria corresponding to the approved data set to be supplied by each site.
3. It submits separate requests to each of four data sites. 
   • Each data site will receive a list of patients using the site local identifier and return the matching set of records defined in the Data Use Agreement.
4. 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.

Core Issue: Combining data sets from multiple sites governed by data use agreements.