The CRDS team assists UW investigators with developing data queries and securely delivering both de-identified data and patient-specific data from the UW Health Enterprise Data Warehouse (EDW). This data can be used to support your research including feasibility assessments, recruitment of participants, pilot studies, and retrospective analyses.
The CRDS team handles two types of requests: Feasibility Counts and Data Requests. Feasibility Counts are simple requests for count level data, i.e., “How many patients in the UW Health EDW meet criteria X, Y, and Z?” You may be likely to use CRDS if your feasibility counts require complex data queries (for example multi-term or conditional queries), if you want to access data that is not available in i2b2, or if the patient data contains protected health information (PHI).
Data Requests involve more detailed level data than simple feasibility counts, and may require IRB approval or waiver depending upon whether the request contains only de-identified data, a limited data set, or fully identified data.
Meet the CRDS Director:
CRDS is led by the director of Clinical/Health Informatics within the ICTR BMI group, Eneida Mendonça, MD, PhD, associate professor of Biostatistics and Medical Informatics.
She leads a team of three to four data analysts and two SMPH IT staff. Current CRDS team members include Lisa Gress, Yiqiang Song, Gabriel McMahan, Debbie Yoshihara, and Tom Mish.
Working with CRDS
Using the Consult Form to Get CRDS Services
- Submit a BMI Consult form and select “I need assistance from the Clinical Research Data Service (CRDS) team” under the Preparatory to Research Activities heading.
- Pick the most accurate description of your data needs and provide any additional information requested, including IRB review status and project funding if available.
- Fill out as much of the optional Data Elements section at the end of the form as you can.
Do I need IRB approval?
IRB approval is required for data requests that require identifiable private information and that meets the federal definition of research. The UW-Madison Health Sciences Institutional Review Board (HS-IRB) website has more guidance, e.g., Does My Research Need IRB Review? and Change in Personnel guidance.
Activities preparatory to research
De-identified data requests to determine study feasibility or plans for participant recruitment do NOT require IRB review. Active participant recruitment DOES need IRB approval.
How do I request clinical data?
Clinical data can be requested through the BMI consult form. The more preparation you do, the better we can help you with your data request. To help you fill out the optional Data Elements section of the consult form, begin by creating a detailed description of the patients who are relevant to your research question, including dates of service, demographics, diagnoses, procedures, treatments, and lab tests and determining exact ICD9, ICD10 and CPT codes for your query. Other elements to consider include:
- Inclusion and exclusion criteria
- Inclusion Date Range
- Study population (age, gender, race, ethnicity)
- Data elements needed
- Define the constraints (filters)
- “Medical home” here
- Department restrictions
- Data format for delivery
What should I expect after I've submitted my request?
Step 1: Initial review
We start by evaluating requests to make sure your request is clear, complete, and feasible for us to fulfill. We’ll also verify that the primary requester or the PI is an authorized UW investigator.
Step 2: Fulfillment
Once you and your colleagues are verified as authorized users and IRB approval is confirmed, we can fulfill your data request. When the data is ready, we will email you with instructions for accessing your data.
Step 3: Working with your data
After your request is fulfilled, CRDS members are available to help you better understand and work with your data. This may involve assistance with data visualization and identifying caveats in the clinical data.
How will I access and analyze my data?
Accessing your data
Once your data request has been fulfilled, you’ll receive an e-mail with access to your requested data via REDCap. The REDCap environment protects private patient data, provides data backup, and enables collaboration with colleagues.
What if I need more informatics support?
The CRDS team can also help you work with your data. Complete the BMI Consult form if you want to:
- Get help managing your data.
- Get informatics support for grant applications.
- Be introduced to other informatics experts.