Research Design, Compliance, and Data Management (RDCD)

NIH RePORTER · NIH · P20 · $252,707 · view on reporter.nih.gov ↗

Abstract

The Research Design, Compliance, and Data Management (RDCD) Core envisions itself as an unwavering beacon, dedicated to supporting LCTRC investigators with timely and robust statistical assistance on experimental design and data analysis, access to Electronic Health Records (EHR) databases to conduct C&T research, facilitation of clinical trials and creation of research databases, and guidance and resources on risk management, federal regulatory, and reporting compliance on human subjects’ research. The UofL RDCD Core is under the leadership of Dr. Maiying Kong, who is a professor in the UofL Department of Bioinformatics and Biostatistics (DBB), holds the Wendell Cherry Chair in Clinical Trial Research, and is the Director of Biostatistics Core at the UofL Brown Cancer Center (BCC). She has formed a talented team that includes four faculty members from the DBB, the UofL Health (ULH) Chief Medical Information Officer (Dr. Sunita Kasliwal) and her staff, and the Chief Director of the UofL Clinical Trial Unit (Rachel Sheppard) and her staff. The RDCD Core aims to foster close collaboration between these accomplished DBB members and the C&T researchers. While ULH possesses valuable access to two extensive EHR databases, Epic Cosmos and the Cerner Learning Health Network (LHN), availability of these databases to UofL C&T researchers has been restricted. The RDCD Core is taking proactive steps to establish a partnership with ULH to make these EHR databases accessible to UofL C&T researchers. In conclusion, the RDCD Core will harness a wealth of expertise and resources to bring its vision to fruition through the following Specific Aims: Specific Aim 1: Provide state-of-the-art statistical support in design, analysis, and dissemination of findings across a spectrum of basic science, translational, clinical, and population health studies. Specific Aim 2: Facilitate and provide guidance on the use of EHR and other large clinical datasets to ensure compliance with NIH and institutional data management policies to safeguard protected health information. Specific Aim 3: Provide guidance, resources, and training to enhance the competency of LCTRC researchers in conducting human subjects research. Impact: RDCD Core is an essential piece of a successful UofL CTR-D program. The successful execution of this core will establish a centralized resource and coordination hub to provide LCTRC investigators with essential support in research design, data analysis, compliance, and data management. Furthermore, through our partnership with ULH, we will make both national Epic Cosmos and the Cerner LHN EHR databases, and local EDW databases accessible, which will enable LCTRC investigators to conduct C&T research with heightened efficiency, precision, and put a direct focus on improving patient care.

Key facts

NIH application ID
10983876
Project number
1P20GM155899-01
Recipient
UNIVERSITY OF LOUISVILLE
Principal Investigator
Maiying Kong
Activity code
P20
Funding institute
NIH
Fiscal year
2024
Award amount
$252,707
Award type
1
Project period
2024-07-10 → 2029-06-30