Requesting Data Extracts & IRB Requirements


What is the general process of requesting data extracts or informatics support?

  1. Investigators or a designated delegate are required to submit a service request through the CCTS Service Request System. A confirmation email will be received when the request is received and assigned to the CCTS Biomedical Informatics (BI) Core. 
  2. The BI Core Manager will follow up with requester when the request is received. Requests are processed in the order they are received, but investigators should inform the CCTS BI Core team of any critical deadlines.
  3. The Data Request Authorization (DRA) form is sent to the investigator for completion. The BI Core Manager will review this form and send back a PDF copy with additional instructions.
    • Requests are reviewed for technical and regulatory feasibility by the CCTS BI Core Team.
    • The investigator will be contacted to gather additional requirements or approvals, as needed.
  4. A technical consultation may be required. The CCTS (BI) Core Manager will contact the PI to set up a meeting time.
  5. If the project is feasible, the CCTS BI Core team will review and agree on a project plan, timeline, and estimated costs with the investigator prior to data extraction.
  6. The CCTS BI Core team will contact the investigator with any updates during the time of project execution and send a notice when the project is complete. A signed IDUA may be required prior to receiving results.

Are there any costs associated with this process?

The first hour of consultation and requirements gathering, as well as requests for counts that require 1 hour of work or less, are free of charge.  Subsequent hours of service and data extraction will incur an hourly fee. Estimated costs will be established and approved by the investigator prior to data extraction. Please call (312) 413-7316 for additional information on the cost structure.

The CCTS BI Core will also work with investigators who are awaiting funding or seeking informatics support on a grant. Requests for provisional cost waivers will be evaluated on a per-project basis.

What are the IRB Requirements? 

(Note: After your completed DRA form is reviewed, you will receive a pdf copy with a personalized summary of your requirements and next steps.)

For projects without approved protocol:

The pdf copy of your Data Request Authorization (DRA) form should be submitted to IRB with your protocol.

  • The CCTS Biomedical Informatics Core Manager will email you a PDF copy of the DRA form after it is reviewed.
  • Submit the DRA form in OPRS Live under other documents
  • Update protocol to indicate the source of data requested (i.e. CCTS - CRDW – Clinical Research Data Warehouse/UIC CIRCLE)
  • Ensure your protocol document lists all data elements requested – this should match your DRA form

Once the IRB application is approved, submit the approved DRA form, updated protocol document, and a copy of IRB approval letter to the CCTS Biomedical Informatics Core Manager.

​For projects with prior approved protocol:

Complete the Data Request Authorization (DRA) form and submit IRB protocol documents to CCTS Biomedical Informatics Core Manager.

  • If not already stated, update the protocol to indicate the source of data requested (i.e. CCTS - CRDW/UIC CIRCLE) and ensure your protocol document lists all data elements requested (this should match your DRA form)
  • Submit IRB amendment with completed DRA form – you will retrieve a PDF copy of the DRA form that can be uploaded to OPRS Live.
  • Once the IRB application is approved, submit the approved DRA form, updated protocol document, and a copy of IRB approval letter to the CCTS Biomedical Informatics Core Manager

OR

If the protocol document already lists all requested data elements and source of data, the CCTS Biomedical Informatics Core Manager will review these items to determine if further IRB approval is required.

  • If all requirements are met, no additional IRB approval will be required.
  • If it is determined that additional IRB approval is required:
    • Submit IRB amendment with the completed DRA form – you will retrieve a PDF copy that can be uploaded to OPRS Live.
    • Once the IRB application is approved, submit the approved DRA form, updated protocol document, and a copy of IRB approval letter to the CCTS Biomedical Informatics Core Manager.

 

See other UIC CIRCLE FAQs