CERID RESEARCH SUPPORT UNITS
Database Management Unit
Unit Director: Kimberley Buckner
Members of this unit have expertise with the use of REDCap® (Research Electronic Data Capture). REDCap® provides investigators with a software tool that facilitates the development of a specific research database according to the particular research project. REDCap® is now a collaborative international consortium and includes over 300 institutions across the world.
The primary activities of this unit include development of study databases utilizing REDCap® software. In conjunction with the Statistical Analysis Unit, this unit is also responsible for development of the data dictionary to ensure an appropriate mapping from the case report form to the electronic database, and consistency for statistical analysis. The unit is also in charge of providing data security for the clinical data during data collection, transmission, and storage.
Data Quality Unit
Unit Director: Mohammad Tahboub
Members of this unit assure the identification of eligible patients based on study criteria in both the screening and enrollment processes. The unit ensures data validity through the generation and response to data quality queries and data quality rules in REDCap®. Discrepancies at any level of data quality generate queries that will be corrected by the study coordinator who collected the data from the patient’s medical record. After discrepancies are resolved, a final verified study database is compiled.
Regulatory & Compliance Unit
The primary activities of this unit include development of study consent forms and other regulatory documents; serving as liaison with the Institutional Review Board (IRB) and research offices at the different sites; preparing all documents required for IRB submissions; reporting protocol deviations and severe adverse events to the IRB; verification of IRB approvals including all study documents and at all clinical sites, verification of amendments at all clinical sites to ensure appropriate protocol, consents and other documents are being used; and assuring that all relevant IRB correspondence (continuing review and amendments) and study status changes are communicated in real-time to all sites. The unit is also in charge of credentialing all research staff at participating facilities.
Statistical Analysis Unit
Unit Director: Stephen Furmanek
This unit performs real-time descriptive and inferential statistical analysis and visualization of study data using R, ArcGIS, and SaTScan software. Real-time data visualization with graphical outputs such as boxplots, histograms, and maps are developed. This team is also responsible for examination of aggregate data to identify potential site variations. These results can then be shared with other units that can identify reasons for such variation, and can then guide the development and implementation of a corrective process.
Unit Director: Subathra Marimuthu
As samples of clinical material are obtained as part of clinical studies, the clinical investigator will need to create and maintain a biorepository. Members of this unit develop and implement procedures for study supplies, specimen processing and maintenance, and analysis. The unit tracks and ships specimens, including documentation of receipts, and stores study specimens and their locations within REDCap®.
Community Engagement Unit
Unit Director: Dawn Balcom, DNP
The primary role of this unit is to maintain open lines of communication between the Center and the different community stakeholders. One of the Center’s goals is to perform research that can improve the health of the Louisville community. The community needs to be aware of the Center’s activities, and the Center needs to be aware of the research needs of the community. This unit will facilitate the articulation of a shared research plan with our community stakeholders.
Information Technology Unit
Unit Director: Matthew Grassman
Exchange of electronic data using computers and other physical devices is an important activity of the clinical research operation. To secure the proper maintenance of computers, software, and networks among members of the Center, we created an information technology unit. Members of this unit determine then implement plans for optimal functioning of employee technology, detailed inventory of hardware and software, and respond to technology issues as needed by utilization of an IT help-ticket system.
Unit Director: Eman Abbas
This unit address the human resources elements of the Center and ensures compliance with local, state, and federal policies and procedures. The unit also is in charge of hiring new employees, processing payroll, management of employee leave requests, schedules and calendar management.
Unit Director: Daniel Kapp
This unit is involved in contract negotiations and financial compliance. The unit also monitors study payment milestones.