The Research Support and Statistics Core (Core A) is responsible for the overall integration of the statistics, data management, and administrative functions of this SCCOR. The Core will be led by SCCOR Director, Jane Newburger, Core Co-Principal Investigator, David Wypij, and co-investigator in biostatistics, Kimberlee Gauvreau. Key support personnel in this Core will be a programmer (Ludmila Kyn), administrator (Kathleen Alexander), data manager (Donna Donati), and research assistant (Carolyn Jun). This staff, which will support all the projects in the SCCOR, is in a centralized data coordinating center on the second floor of the Bader Building at Children's Hospital, in close proximity to the SCCOR project investigators. This Core willbe a resource to project investigators in addressing issues that may result from the study of patients or the use of patient-based materials. The purposes of the Research Support and Statistics Core are as follows: (1) In collaboration with Project Leaders, to support final protocol development during the Planning Phases of clinical studies, including refinement of study designs, eligibility criteria, baseline and outcome measures, power and sample size calculations, randomization methods, statistical analysis plans (including early stopping rules) and ethical considerations; (2) To assist in overall study coordination of clinical projects, including coordination of patient follow-up, training of study personnel, quality control and quality assurance, development of Case Report Forms and Manuals of Operations, database development, data entry, database checks and updates, and maintenance of blinding and firewalls. (3) To perform interim statistical analyses and study monitoring (including adverse event monitoring and Data and Safety Monitoring Board reports). (4) To plan and perform final data analyses, support publication and abstract preparation, and create final data sets for archival purposes. (5) To plan and analyze ancillary studies, such as mechanistic studies or analyses of the association of clinical variables with laboratory analyses; and (6) To provideadministrative support as needed for research excellence in the SCCOR. In summary, Core A provides the infrastructure necessary to facilitate the conduct of clinical research projects, translational research and basic research in this SCCOR.
Showing the most recent 10 out of 43 publications
