John D. Sorkin, M.D., Ph.D., Co-Leader
Telephone: 410-605-7119
E-mail: jsorkin@grecc.umaryland.edu Michael Terrin, M.D., M.P.H., Co-Leader
Telephone: 410-706-6139
E-mail: mterrin@epi.umaryland.edu
The Biostatistics and Informatics Core will gather data from the UM-OAIC research cores and studies, provide and manage a centralized data system for the storage of study data, and perform analyses that combine data across research cores and studies. Research Core 5 will be a focal point for all UM-OAIC research and will promote synergy among studies and research cores producing a Center that is more than the sum of its parts. The aims of Research Core 5 that complement the other research cores are: 1. Assist UM-OAIC researchers in the design and conduct of their studies, and the analysis and interpretation of their data: A. Centralized information system for the acquisition, storage, and review of data. B. Informatics resources for study coordination, including a subject registry, protocol and data tracking system, data management, and safety monitoring. C. Merge data across UM-OAIC studies to identify predictors of disability and successful rehabilitation. D. Insure the confidentiality, physical security, and logical integrity of all data.
2. Teach UM-OAIC faculty, trainees, and staff statistical methods, epidemiologic principles and basics of study design.
Research Core 5 will support researchers by helping them design and execute their studies and by managing and helping to analyze study data. The Core will perform power calculations (including allowance for subjects lost to follow-up), and randomize subjects. Research Core 5 will also provide a centralized, user-friendly, secure, regularly backed-up, data management system called GERI. GERI will be used to store, review, and access data generated by UM-OAIC researchers, and research cores. The Tracking, Adjudication, Medication databases and the Adverse Event Reporting System will assist researchers and leadership to manage UM-OAIC studies. A series of bi-weekly reports will (1) document completeness of the data and identify missing data elements, (2) facilitate data verification by listing new subjects and data added to the database since the last report, (3) examine study data looking for extreme, and possibly erroneous values using exploratory data analysis and bivariate correlations of related data, and (4) review entry of subjects into each research protocol to determine if entry keeps up with recruiting goals. Research Core 5 will assist the Safety Monitoring Board with overseeing UM-OAIC studies.
|
