The University of Michigan (U-M) Udall Center Biostatistics and Data Management Core provides vital biostatistical support, data management, and predictive analytics for the Udall Center. Core investigators also actively participate and contribute to the national Udall program and the wider Parkinson?s disease (PD) research community.
The specific aims of the Core are designed to ensure broad and reliable support of all Udall Center investigators, external collaborators, and the wider PD research community.
Aim 1 of the Core is to provide technical, computational, and biostatistical support of the Center projects, including design of experiments, statistical analyses using modern, state-of-the-art statistical models and analytic methods, result interpretation, and effective dissemination of research findings.
Aim 2 is to advance the methods and analytic capabilities and expertise in the Center. To enable complex analytics on heterogeneous Udall PD data (e.g., imaging, clinical, physiological, gate, genetics), we will implement and deploy techniques and protocols to represent and analyze multi-source neurodegenerative data and apply tools for data harmonization and visualization. We will offer training materials and educational opportunities for students, fellows, junior faculty, and research investigators, and community PD advocates. Core investigators will assist Udall scholars, collaborators, and trainees with formulation, testing and validation of appropriate research hypotheses, data collection, management, processing, visualization and interpretation. To ensure uniform formats and vocabularies that facilitate analyses and sharing of resulting data, the NINDS Parkinson?s Disease Common Data Elements (CDEs, CommonDataElements.ninds.nih.gov/PD.aspx) are used. Electronic case report forms (eCRFs) are incorporated into the 21 CFR Part 11-compliant web-based relational database OpenClinica. De-identified data are deposited into a Data Archive and the NINDS Data Management Resource (DMR). The NINDS DMR repository requires use of Global Unique Identifiers (GUIDs) that facilitate data aggregation without exposing/transferring Personally Identifying Information. Data standardization complies with NINDS Parkinson's Disease Biomarkers Program (PDBP) protocols for storage and access. U-M Udall Center clinical data will continue to be uploaded into the PDBP DMR to facilitate data aggregation and sharing with the broader community. The Center website will provide direct links to access summary statistics (data dashboard), manage community requests for samples and data, and disseminate research findings and computational protocols. The Biostatistics and Data Management Core will enhance the research, computational and analytic capabilities of the U-M Udall Center, facilitate PD-related research locally, and contribute unique clinical, biomarker and imaging data to national repositories for broad community use.
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