With the launch of the enhanced Analytics Core (ACReS) request system on 3/17/2021, the Office of Clinical Research and the Center for Research Informatics are pleased to announce the launch of the pre-IRB consultation service for clinical research data and informatics requests.
The service is required for requests for data on 500 or more UCM patients. If you wish to obtain data from the Clinical Research Data Warehouse (CRDW) on less than 500 patients or your project has informatics or information technology (e.g. virtual machines, commercial stats packages, new software/hardware, etc.), this consultation process is suggested but not required. This is not applicable if you are conducting a clinical trial.
Prior to submitting your IRB application, please submit a request for consultation at https://bsdfeasibilityconsult.uchicago.edu/ and proceed with self-scheduling office hours with a member of the Center for Research Informatics’ (CRI) Clinical Research Informatics team. The consultation process provides faculty and their research teams with an opportunity to optimize their data or informatics request and streamline the various processes that are often required when conducting clinical research with clinically-derived datasets or informatics requirements. At the conclusion of the consultation, a letter from the CRI will be provided for inclusion with the IRB submission. (Note: If you already have an approved IRB approved protocol that meets the criteria above or have already submitted an ACReS request, please submit for feasibility consultation and schedule office hours if you haven’t yet been in contact with a CRI team member.)
The benefits of this new process are:
- A more complete data request, informed IRB and/or Data Use Agreement submission and streamlined regulatory review
- Formalizes CRI role as source of clinical data when appropriate
- Provides research team with best practices and data/technical solutions in addition to direct connections to non-CRI resources
- Supports BSD IRB in issues related to availability/accessibility and storage of data.
We will continue to partner with UCM and the enhanced ACReS system and our colleagues in the IRB, Privacy office, University and UCM legal, and URA. With the enhanced service, we are also pleased to provide a streamlined technological solution as well, with auto-ticketing of clinical research requests within ACReS post-consultation, eliminating the need for duplicate submissions in disparate systems.
This flow diagram was created to help guide your decision-making. If you have questions or comments regarding this service, please contact Walt Stadler, Beth Martell, or Julie Johnson. If you need to reach a member of the Clinical Research Informatics team in the CRI, please email email@example.com. We look forward to partnering with you to optimize your research and appreciate your support and patience as we transition.