What is the difference between “Cohort Mode” and “De-Identified Mode”?
- 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.
What are the prerequisites for accessing Cohort Mode?
What are the prerequisites for accessing De-Identified 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 PHDataHelp@umich.edu.
Can I access DataDirect off-site?
Yes, DUO authentication enables DataDirect access both from campus and off-campus; however, the individual will need to log on through a university VPN.
When I enter a diagnosis in the search field, several ICD codes are displayed. How do I know which one/s to select?
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.
How do I share a query?
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.
Is there a variable for “reason for visit”?
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 following this link.
Does encounter data contain any physician notes from discussions with the patient?
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 for Clinical & Translational Research (DOCTR) following this link.
I have a HUM# from an IRB approved study. The IRB does not specifically state we will be using DataDirect, can I still use this HUM for using the tool? Do I need a specific IRB only for using the self-serve DataDirect tool?
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.
Are echocardiograph interpretations available through DataDirect?
Currently, echocardiograph interpretations aren’t available through DataDirect. However, the DOCTR team can do a custom pull (fee for service) for them following this link.
VIDEO: How do I connect to Precision Health DataDirect? (campus-wide)
How do I use the U-M Box to secure store research data?
Research data can be sensitive and needs to be stored in a HIPAA secure online environment. Using a properly configured Shared U-M Box account, you can securely store patient health data. A shared account is not tied to an individual’s uniqname and will remain in place should any collaborator leave the project.
Check out the full guide!