The Udall Center Biostatistics and Data Management Core will provide vital biostatistical support and data management for the Udall Center and contribute to the national Udall program and wider Parkinson's disease research community. The two specific aims of the Core are designed to ensure broad and reliable support of all Udall Center investigators, as well as external collaborators and the wider Parkinson's community. The first specific aim of the Core is to provide computational and statistical support of the Center projects, including design of experiments, statistical analyses using modern, state-of-the-art statistical models and methods, and interpretation of analyses leading to dissemination of research findings in manuscripts and scientific presentations.
The second aim i s to develop a federated database for imaging, clinical, and biomarker data that supports the research studies, collaborative interactions within the Center and nationally across all Udall Centers, and ensures that data management and quality controls are applied for all projects. Core investigators will assist Udall investigators, collaborators, and trainees with formulation, testing and validation of appropriate research hypotheses, and 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, (www.CommonDataElements.ninds.nih.gov/PD.aspx) will be used. Electronic case report forms (eCRFs) will be incorporated into the 21 CFR Part 11-compliant web-based relational database OpenClinica (see Facilities and Resources for more information on OpenClinica). De-identified data will be deposited into the Imaging Data Archive (IDA) and the NINDS Data Management Resource (DMR). The IDA data management service (http://ida.loni.usc.edu) will utilize the established PPMI data schema (www.ppmi-info.org). The NINDS DMR repository requires the use of a Global Unique Identifier (GUID) that facilitates data aggregation without exposing/transferring Personally Identifying Information. Data standardization will comply with NINDS Parkinson's Disease Biomarkers Program (PDBP) protocols for storage and access. Clinical data will be entered into the PDBP DMR via the ProFoRMS interface in order to broadly share data with investigators through the NINDS PDBP DMR. The Center web-site 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 impact of the Biostatistics and Data Management Core will be to enhance the success of the Udall projects, to facilitate PD-related research locally, and to contribute unique clinical, biomarker and imaging data to national repositories for broad community use.