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- Cohort Mode is used to define a cohort (group of patients/subjects of interest) based on inclusion criteria by filtering against defined data fields and provides aggregate counts only for patients who meet that criteria allowing the researcher to understand how many patients meet the criteria to be included in their research group.
- De-Identified Mode allows users to access de-identified patient health data for a defined cohort. These cohorts can initially be assembled using Cohort Mode.
- Level-1 password
- Completion of HIPAA Training through MyLinc
- Active certification of PEERRS: Human Subjects Research Protections through MyLinc
- Enrollment in DUO Authentication
- Investigators are required to go through IRBMED (not HSBS) and attain, at a minimum, a self-determination for not regulated research
- U-M faculty position, or U-M staff/student with a faculty sponsor. Faculty are responsible for uploading uniqnames for their staff/students into DataDirect.
- Sponsored users will not be granted access until a signed paper attestation, from both the faculty and the person sponsored, is emailed to [email protected].
Yes, DUO authentication enables DataDirect access both from campus and off-campus; however, the individual will need to log on through a university VPN.
Determining which codes meet your inclusion criteria is a clinically informed decision to be made by your research team. Several different codes can be associated with a diagnosis/procedure. Consulting with a clinician who specializes in this area or reviewing the charts of patients known to have the diagnosis/procedure can assist in this determination.
In the upper right corner of the screen, there is a drop down option. Select “Share Your Query” within that menu. Sharing your query with team members can be used to reach a consensus on DataDirect inclusion selections. Your team members must also be authorized to use DataDirect.
Unfortunately, currently DataDirect does not capture reason for visit (follow-up or whether initiated by patient). However, the DOCTR team can do a custom pull (fee for service) for them.
DataDirect encounter data does not contain physician notes. If you are interested in physician notes, you can retrieve those through a custom pull (fee for service) from the Data Office.
As long as the HUM# allows for access to clinical data, then it does not have to specifically mention use of DataDirect. However, it is important to list in section 25 of the IRB application which variables you are interested in so it integrates with the DataDirect domains and it will control access on some level this way.
Currently, echocardiograph interpretations aren’t available through DataDirect. However, the DOCTR team can do a custom pull (fee for service).
Use of patient health data for research is a privilege that comes with great responsibility. Researchers are required to securely store patient health data in a HIPAA-configured location that has been set up to store sensitive data. Michigan Medicine prohibits the use of personally owned devices for storing patient data. Even if you believe most or all of the patient identifiers have been removed, the Data Office still requires that data be stored securely on HIPAA-aligned servers.
CLICK HERE for details regarding HIPAA safeguards when storing patient health data in U-M Dropbox.
The Data Office for Clinical & Translational Research, a unit of the Medical School Office of Research, fosters the translation of data into research that improves clinical outcomes by bridging the gap between personal health data and clinical research.