https://healthdev.ou.edu/research/research-support Parent Page: Research Support id: 33827 Active Page: Clinical Research Data Warehouse (CRDW) id: 33150

Clinical Research Data Warehouse

The Clinical Research Data Warehouse (CRDW) is a partnership between OU College of Medicine, Oklahoma Shared Clinical and Translational Resources (OSCTR), and OU Health. The CRDW is working to connect electronic medical records (EMRs) to research and quality improvement/quality assurance (QI/QA) communities. The CRDW supports OUHSC's ability to compete for grants by allowing access to inpatient and outpatient EMRs. CRDW also helps improve care for patients by supporting the facilitation of meaningful local surveillance programs. CRDW is committed to avoiding undesirable work-arounds which create risk for duplicate data entry, poor data quality, and poorly managed smaller databases.

Some of the frequently requested services to CRDW include: 

  • Feasibility assessments in preparation for research
  • Static patient eligibility for research (patient pools)
  • Rolling patient eligibility
  • Clinical outcomes for retrospective investigations
  • Administrative outcomes for quality improvement
  • Program evaluation

Investigators who would like to request support from CRDW should submit a request form:

Request CRDW Support

Find us on GitHub!

Please note, many projects requesting data from CRDW will require approval from the Clinical Research Informatics Oversight Committee (CRIOC). This is in addition to the typical processes including relevant regulatory review (IRB).If your project involves any of the following, we recommend also submitting a CRIOC review request form as early as possible in your data extraction process: 

  • projects involving sharing of Electronic Health Record (EHR) data outside of OU Health/University of Oklahoma Health Sciences (note: Norman campus is considered external for EHR records use)
  • projects involving a large number of records to review
  • projects involving a novel method for accessing or storing data

CRDW researcher workflow

After you submit a request (use the button link at the top of this webpage), you will be contacted by a member of the CRDW analytics team to set up a meeting to discuss your data needs. Please note, the CRDW provides support in access to data; however, we do not advise on statistical analysis plans or methodology. For support with methodology, please check out resources at BBMC (for Pediatrics investigators) and OSCTR

At this meeting, we will discuss your request and learn more about how we can address your study's needs. Topics of conversation will include:

  • Inclusion criteria and how this can be identified in EMR (e.g., ICD codes, CPT codes, visit locations, medication lists, etc.). 
    • If IRB is already approved, it can be helpful to have examples available to review so we can validate and verify we are identifying the correct data.
  • Timelines/deadlines
  • IRB considerations

For some projects, we may need to send your team files to specify some criteria. For instance, we may send you an ICD range or all medications that have a certain set of characters and request that you define which are the appropriate to use by choosing True/False for each type.  

The time it will take to process your request will vary widely depending on several factors including existing workloads, deadlines, how complicated a request is, how responsive your team is about questions, and needing to do additional processing to access data.  CRDW is obligated to prioritize projects that contribute funding to support our mission.

Once we have assembled your data, we will meet with you to verify we have correctly retrieved data that meets the needs and the IRB-approved specifications of your project.  

If your project will require use of a larger dataset, or if you are sharing any data outside of OUHSC/OU Health (even in aggregate), you must also submit a request to the Clinical Research Informatics Oversight Committee at https://redcap.link/crioc_review .

About CRDW data ingestion process

The Research Electronic Data Capture (REDCap) system and REDCap Survey are powerful software programs created by Vanderbilt University and supported by the REDCap Consortium to facilitate Institutional Review Board (IRB)-approved clinical research and basic research. Data collected in the course of the research are managed by the program, and can be analyzed by commonly used statistical packages, including SAS, Stata, SPSS, and R.

REDCap is a browser-based, metadata-driven electronic data capture software created by Vanderbilt University. The REDCap Consortium is composed of nearly 900 active institutional partners from more than 70 countries. Programming, networking or database experience is not needed to use REDCap. It is designed to use simple interfaces that handle these details automatically. REDCap is secure and web-based: you can input data or build an online survey or database from anywhere in the world over a secure web connection with authentication and data logging. REDCap allows multi-site access for research that uses multiples sites and institutions. OUHSC maintains three instances of REDCap: the Biomedical and Behavior Methodology Core Customization Instance , the Enterprise Instance, and the Development Instance.

 

The REDCap system provides functionality and features to enable researchers to rapidly develop databases and online surveys. These databases, data entry forms, and surveys are intuitive, easy to use tools for collecting data, including data validation.

The design, use, and maintenance of REDCap are managed by the Biomedical and Behavioral Methodology Core (BBMC). The BBMC supports and enhances study design, data capture, and analytics for Pediatrics research.

REDCap has a flexible and fine-grained authorization matrix, allowing different members of the study team to have different levels of access (none, read-only or edit) to data entry forms, and access to database management and data export tools. There are provisions to restrict access to data export to allow export of de-identified data only. Advanced features of the system include branching logic for dynamic data entry form generation, file uploading, data importing, and embedded calculated database fields.

REDCap enforces authorization granted to each user by providing and/or enabling certain functions, tabs, links and buttons according to granted privileges.

REDCap includes a full audit trail, recording all operations on the data, including viewing and exporting. The audit log records operation, date and time, and the user performing the operation, permitting review of the audit trail as necessary.

REDCap enforces data integrity protection by design; all “databases” created by users are logical data sets on top of a relational database with built-in integrity protection controls. Additionally, REDCap can help to ensure data quality through use of Double Data Entry mode, forms and records locking and electronic signatures.

CRDW Data Sources

  • Legacy EHR systems:
    • Centricity/Athena
    • Billing and Claims
    • Meditech
  • Epic 
  • Dozens of departmental sources
  • Biomedical Research Data
  • Provider data
  • External agencies (Oklahoma State Department of Health, Oklahoma Department of Human Services, etc.)
  • Administrative cost

National Registry Projects CRDW Supports

  • Oncology Research Information Exchange Network (ORIEN)
  • Oncologic Outcomes in Renal Cell Carcinoma
  • N3C (National COVID Cohort Collaborative)
    • Investigators who would like access to the N3C Enclave should reach out to us!

Example IRB Protocol Language for Projects using CRDW data

Data will be obtained from (*list data sources here*), (*some/all*) of which currently reside as data sources in the OUHSC Clinical Research Data Warehouse (CRDW). The CRDW is managed by the Biomedical and Behavioral Methodology Core (BBMC; https://ouhsc.edu/bbmc/). Data from these systems will be queried to: (*modify as needed: identify eligible participants and extract clinical information to support recruitment and/or analysis*). 


Eligible participants will be meet the following conditions for inclusion: (*list age, gender, race, ethnicity, diagnosis, visit/admission, location of care, or other requirements*). Data extracted to support this study will include: (*select all that apply: patient identifiers, demographics, appointment/visit information, labs, medications, orders, provider notes*), and other relevant clinical documentation. Information will be released to authorized study personnel via (*select the preferred method of delivery: a csv file, REDcap, write to secure file server, other*).

Projects using OU Health EHR data that sharing outside of OUH/University of Oklahoma Health Sciences

If you are using data from EHR (Epic, Centricity/athenaFlow, Meditech, GE Centricity Billing or Scheduling), and the project involves sharing outside of University/OUH for any reason in any form, please also submit the details about your project to the Clinical Research Informatics Oversight Committee (CRIOC) for review. Even if data to be shared are only in aggregate, please follow this process. Most researchers working with Office of Research Administration for a Data Use Agreement or Data Sharing Agreement will be referred to CRIOC, but you do not need to wait for this to initiate the process.

CRDW can work on assembling your request prior to CRIOC approval, but if your project will require CRIOC approval, we will be unable to release any data with PHI until approval is obtained.

CRDW Contact Info

  General Inquiries bbmc@ouhsc.edu 
William Beasley, Ph.D. BBMC Director of Informatics whb4@ou.edu
Ashley Thumann, MHA EHR Liaison, Senior Data Analyst    Ashley-Thumann@ouhsc.edu
Arnold Kanagwa, MS Sr. Data Scientist Bingi-A-Kanagwa@ouhsc.edu
Geneva Daniel, MS, MHR      Sr. Data Scientist Geneva-Daniel@ouhsc.edu