# Research Design, Compliance, and Data Management (RDCD)

> **NIH NIH P20** · UNIVERSITY OF LOUISVILLE · 2024 · $252,707

## 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 organization:** UNIVERSITY OF LOUISVILLE
- **Principal Investigator:** Maiying Kong
- **Activity code:** P20 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $252,707
- **Award type:** 1
- **Project period:** 2024-07-10 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10983876

## Citation

> US National Institutes of Health, RePORTER application 10983876, Research Design, Compliance, and Data Management (RDCD) (1P20GM155899-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10983876. Licensed CC0.

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