Members of this unit maintain REDCap™ (Research Electronic Data Capture) – a central data collection platform with independent systems fully customized for individual functionality, security and data input satisfying HIPAA and FERPA compliance – to produce custom-built electronic databases and provide data security for the clinical data during data collection, transmission, and storage. REDCap™ is a collaborative international consortium that includes over 300 institutions across the world.
Research & Diagnostic Laboratory
As the University of Louisville’s only Clinical Laboratory Improvement Amendments (CLIA) certified in-house laboratory, our dual support model Laboratory performs applied research and provides quality-assured diagnostic testing services to 14 Louisville-area hospital systems in less than 24 hours.
Unit members coordinate all management practices for the Biorepository including Standard Operating Protocols for collected samples and designated lab references in REDCap™. Staff manage the collection, processing and release of more than 60,000 clinical human specimens of urine, blood (plasma and buffy coat), sputum, oral, nasopharyngeal swabs and clinical isolates for use in clinical and applied research.
Members of this unit oversee Quality Management Systems to ensure the real-time and retrospective accuracy, consistency, compliance, and validity of data inputs for the study life cycle through the generation and response to data quality queries and data quality rules in REDCap®. Quality control is performed at all levels, and queries generated from discrepancies in data quality are corrected immediately.
Responsible for transforming raw data into interpretable results, the biostatistics team uses the newest technologies to perform every step of the analysis process through real-time descriptive and inferential statistical analysis of study data using R, ArcGIS, and SaTScan software. Additionally, the team provides real-time data visualization with graphical outputs such as boxplots, histograms, and heat maps.
Exchange of electronic data using computers and other physical devices is an important activity of the clinical research operation. The informatics unit oversees the information technology infrastructure to support Medical Research Informatics solutions that facilitate the secure processing, communication, and storage of data. Unit members maintain three database production systems; support basic technology needs for Center employees through central ticketing system; and develop innovative technologies to advance data and information management systems.
The administrative team coordinates with all primary and secondary administrative operating units, managing core office operations; providing Human Resource support for staff recruitment, onboarding, VISA processing, scheduling, and professional development; and ensuring compliance with local, state, and federal policies and procedures related to personnel management.
Regulatory & Compliance
As the liaison to the UofL Institutional Review Board (IRB) and 10 Louisville-area health partners, unit members ensure protection of the Center and participating patients by completing all regulatory submission requirements and maintaining all compliance policy, procedure and guideline requirements.
Managing overall receiving, acknowledgement, reconciliation, and reporting of generated revenues from multiple funding sources, this unit is involved in contract negotiations and financial compliance as well as monitoring study payment milestones.
The marketing unit promotes the activities of CERID to all audiences in Louisville, the US, and internationally through study materials, public awareness, news stories and stakeholder engagements. The marketing unit director also serves as the Managing Editor for the University of Louisville Journal of Respiratory Infections and the Journal of Refugee & Global Health as well as coordinates the Center’s clinical research training conferences.
In support of our mission to improve the overall health of the Louisville community and beyond, the Community Outreach unit serves as a liaison for the needs of the community and the research activities of the Center by pursuing an open dialogue with community members and stakeholders to facilitate the articulation of a shared research plan with the greatest impact.