Research Design, Compliance and Data Management Core
Research Design, Compliance and Data Management Core (RDCDC) provides expertise and infrastructure to support the design and conduct of clinical and translational research in North Dakota.
Our services include expertise in research design (including power analysis and proper
statistical
methods and education), project management and clinical operations support (covering
the full spectrum of study conduct with a focus on training around research regulations
and compliance), and data management (including EHR access, data set curation, validation,
storage, safeguarding, etc.).
Main Objectives
- Provide comprehensive statistical support
- Lead project management and clinical operations activities
- Offer data management support
- Develop and cultivate training and connections
Collaborations
Resources
- Statistical Training Materials
- Database Access
- Science Podcast
- Other
Faculty
Junguk Hur, PhD - Core Lead
Dr. Junguk Hur is an Associate Professor and researcher for the Biomedical Sciences Department and serves as the Director of the Computational Data Analysis Core for the Host-Pathogen Interaction CoBRE at UND. He is highly experienced in the field of bioinformatics, with a focus on developing computational methods to understand human diseases and to identify new therapeutic targets through integrative bioinformatics approaches that emphasize the advanced analysis of various high-throughput Omics data and integration with biological and clinical data. This includes expertise in RNA-Seq, ChIP-Seq, metabolomics, lipidomics, and metagenomics to enhance the integrative data analysis of big data. Dr. Hur's research interests include computational modeling of diabetic neuropathy, high-throughput Omics data analysis in neurological disorders, biomedical literature mining, and systems pharmacology modeling of drug adverse events.
Lora Black, RN, MPH - Core Co-Lead
Lora Black is the Executive Director of Clinical Research at Sanford Research. She has oversight for clinical research performed across the whole of Sanford Health. The principal catchment area of Sanford encompasses 200,000 square miles of rural and frontier geography in the upper Midwest. The Clinical Research department functions as the central Clinical Trials Office for Sanford, providing resources to investigators for the completion of study-related activities, from initial concept and protocol development to regulatory submissions and coordination of subject activities during a trial. Ms. Black’s experience includes an extensive knowledge of all facets of clinical research. As such, she is positioned to fill the role of the RDCDC Co-Lead due to her expert-level knowledge of clinical site operations, best practices, and regulatory standards. Additionally, she has substantial experience in protocol development as well as management of multi-site interventional trials.
Marilyn Klug, PhD - Core Co-Lead
Dr. Marilyn Klug is a Professor for the Department of Population Health at UNDSMHS. She has been active in medical research for 30 years. She has contributed as a methodologist for the design and analysis of studies of multiple diseases common in ND, including fetal alcohol spectrum disorder, dementia, and amyotrophic lateral sclerosis. She is familiar with multiple statistical and graphics programs and has taught statistics to students and residents in the medical field. She has developed analytical approaches to several challenging biostatistical questions, including mining and restructuring of large data sets, multiple adjustments and relationships of data, propensity matching, creation and validation of scales, estimation of fitted curves, meta-analysis, and simultaneous equations and structural modeling.
Mark Williamson, Phd - Statistician, Core Coordinator
Dr. Mark Williamson is a Research Assistant Professor, biologist, and statistician with a broad background in scientific and statistical methodology. His current and past epidemiological research includes cancer, neurological disease, and radon.
Kent Ripplinger, MS - Data Navigator
Kent Ripplinger serves as the joint data registries navigator for the TRANSCEND project, along with his current appointment as National Covid Cohort Collaborative (N3C). He has over 20 years of experience in Data Services coordination and expertise in creating complex datasets and teaching people to use them.
Research Project Managers
The RDCDC Project Managers are responsible for providing multi-faceted support for investigators, including particular attention to the oversight or research involving human subjects. Miranda Leitheiser and Cassy Garry, two experienced project managers from Sanford Research—who also were vital members of the previous Dakota-based CTR, the DaCCoTA—will support the RDCDC in this capacity.
TRANSCEND Navigator
The Navigator serves as the primary contact for the CTR at the point of investigator entry. The Navigator connects and guides applicants with potential collaborators, TRANSCEND cores, and other resources. Jamie Scholl, the previous DaCCoTA Navigator, will cover this role with 75% effort, with the remaining 25% of her effort allocated to the Professional Development Core.