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The CCTS Enterprise Data Trust (EDT) integrates the Biomedical Informatics (BMI) team and the Institute for Biomedical Informatics (IBI) team in the development of clinical data sets that researchers can use to expedite research here at UK. The IRB recognizes the CCTS Enterprise Data Trust (EDT) as a third party “honest broker” (pdf) in the approved protocol approved protocol number 45668, “Umbrella IRB for Use of Health Information in the CCTS Enterprise Data Trust- UK HealthCare dataset.” The protocol addresses the appropriate procedures for providing access to clinical data stored within the EDT to researchers when certain types of research are conducted, including training and documentation requirements.  Additional datasets are being added to the Enterprise Data Trust for research purposes. Each dataset will be linked to the main IRB protocol, but each will have specific information that must be communicated regarding data availability, HIPAA privacy concerns, and risk considerations.

Regardless of which dataset the researcher uses, the same process is used for obtaining access the data stored within the CCTS EDT. The steps are listed below:

1. Complete a CCTS Biomedical Informatics Service Request Form for a consultation to determine feasibility. 

   • Researchers will select which dataset is needed.

   • Researcher will indicate if deidentified or dataset with protected health information (PHI) is needed. This will help determine if an IRB is required.

   • Data Use Agreement must be signed by the requester. If a student, the PI must sign as the sponsor. The signed form can be uploaded as a PDF or JIF document without the project manager signature.

   • The HIPAA Refresher Training must be viewed and marked “yes I have reviewed” on the application.

2. If a deidentified dataset is needed from UKHealthCare, VIZIENT, formerly University HealthSystem Consortium (UHC), Humana, TRUVEN, KY Claims, KASPER, or Appalachian Patient Stroke Recovery and Research Registry  dataset then you will not need to get an individual IRB approved. The researcher can use the EDT umbrella IRB associated with that dataset if they are employed by the Covered Entity.

3. Once all requirements have been met, approval is granted by the Project Manager.

   • Data extracts can be completed and released to researcher.

The EDT has multiple data sets available to CCTS members, and a consultation can be scheduled for study feasibility regarding a data extraction by completing the CCTS Service Request Form.