We suggest all UNC investigators request a consult with an analyst at NC TraCS to get started. An analyst will help you determine the best network for your project, assist you with refining your request, and let you know about data availability.
Depending on your project, you may also wish to explore i2b2@UNC, which allows you to query data from the UNC Health Care system and receive a count of patients meeting your criteria. Although it only contains UNC data, i2b2 allows you to familiarize yourself with the data you are looking for before approaching a CDRN.
We also suggest you begin developing a computable phenotype in preparation for a network request.
Each CDRN has a different mission, available data, and partners. An analyst at NC TraCS can help you determine the best network for your project.
PCORnet, or the National Patient Centered Clinical Research Network, contains 9 clinical research networks (CRNs) including the Stakeholders, Technology and Research (STAR) CRN. The STAR CRN includes Vanderbilt Health System (lead site); Meharry Medical College; Vanderbilt Healthcare Affiliated Network; Health Sciences South Carolina (includes Medical University of South Carolina); UNC-Chapel Hill; Duke University; Wake Forest Baptist Health, and Mayo Clinic. The STAR CRN was formerly known as the Mid-South CDRN.
The Accrual to Clinical Trials (ACT) Network is a growing national CDRN, which hosts a real-time platform allowing researchers to explore and validate feasibility for clinical studies across sites. To learn more about ACT and gain access, visit: tracs.unc.edu/act
Data available in the CDRN vary by network. Structured data are generally available in the following domains: patient demographics, encounter information, diagnoses, procedures, laboratory tests, medications, and patient vitals. More details:
PCORnet and STAR: Common Data Model v6.1
UNC Health Care System data in the CDRN dates back to 2004. Availability of historical data varies by health care system.
CDRNs can support a variety of observational and interventional studies, including, but not limited to, cross-sectional studies, health services research, comparative effectiveness studies, pragmatic trials, and clinic trials. Information about current projects:
A computable phenotype is a very specific list of inclusion and exclusion criteria used to identify patients for a study. Below is an example of the type of criteria included in computable phenotypes:
Can you pull data from the CDRN that will show me all patients between ages _____ and _____, who have been diagnosed with _______, but haven't had a ________ in the last 6 months, but have had ___ visits in the _____________ clinic over the past year? I also need to know if they're taking _____________, or have had any ___, ___, or ___ lab values over ___ mg/ml in the past year.
Computable phenotypes are important for any clinical data request, but they are especially important for CDRN requests. A strong computable phenotype will ensure you find expected and like populations across institutions.
UNC-Chapel Hill requires a UNC investigator generally a faculty member to be actively involved in a project in order for that study team to use UNC data.
Note: Although a de-identified data set cannot contain a birth date, it may contain the individual's age expressed in years, months, days, or hours, as appropriate, except for individuals who are aged 90 years or more. For persons aged 90 years and above, the age in a de-identified data set can only be stated as being within the category of age 90 or above.
The IRB approval process for PCORnet and the STAR CRN currently varies on a study-by-study basis.
Any requests for patient-level data whether de-identified, HIPAA-limited, or identified will need to go through a formal approval process that varies by network. Once submitted to the CDRN, requests will be routed through the approval process of that network.
Although we encourage UNC investigators to consult with a TraCS data analyst prior to reaching out to a CDRN, you may make a request directly to one of the CDRNs:
The STAR CRN includes a Stakeholder Advisory Committee which provides feedback on stakeholder engagement activities in CDRN-related projects. To learn more about this process and considerations when planning for stakeholder engagement, view the pdf.
Yes, we have the following materials available: