Versions Compared

Old Version 45

changes.mady.by.user Gagan Jindal

Saved on

compared with

New Version Current

changes.mady.by.user Gagan Jindal

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Please provide any feedback regarding Scenario #1 in the comment form below or by clicking here.

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.

...

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

  • Research organization, Coordinating Center, and Data Site use standard-based interoperability to exchange information in a secure environment.
  • Researcher has approval from IRB to request data for a list of enrolled participants.
  • Research unique identifiers are used to request data to protect the identity of patients so there is a low risk of re-identification.
  • The Coordinating Center provides identity correlation across data sites using a network-wide ID.
  • The Coordinating Center has mapped the data sites that store relevant information for a given protocol/study.
  • All sites have executed a DUA authorizing the Researcher’s organization and its approved representatives to request and receive a minimum data set and use the data set for a research study.

Postconditions

  • Researcher has access to data set and is able to analyze/combine them for a specific research study.

Alternatives

  • DUA or study expired, the Researcher does not have access to the data anymore.
  • Information was sent electronically from data site to the Research Information System that combines the data sets.
  • The researcher could come from a data site. An academic might have access to EMR clinical data locally but not have the longitudinal data from administrative claims, and researchers at health insurers do not have access to EMR clinical data.

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

 

...