Pediatric Fungal Network's (PFN) STudy of Rare Invasive Fungal DisEases in Immunocompromised Pediatric Patients (STRIDE) Administrative Component

Children'S Hosp Of Philadelphia, Philadelphia PA

Investigators

Abstract

ADMINISTRATIVE CORE The Administrative Core of the Pediatric Fungal Network STudy of Rare Invasive Fungal DisEases in Immunocompromised Pediatric Patients (PFN-STRIDE) Rare Diseases Clinical Research Consortium will be based at Children’s Hospital of Philadelphia (CHOP) and led by PFN-STRIDE RDCRC Project Director/Principal Investigator Brian T. Fisher, DO, MSCE with support of his clinical research team. Dr. Fisher’s team at CHOP brings extensive clinical research experience, including work on previous Pediatric Fungal Network studies that will provide a foundation for the research projects within PFN-STRIDE. The Administrative Core’s overarching role will be to support execution of each of the proposed clinical research projects, and to ensure that all project and core teams work in concert toward the vision and goal of improving knowledge, advancing diagnostics, and improving clinical outcomes related to invasive fungal diseases in immunocompromised pediatric patients. The core’s central aims will be to initiate and manage subcontracts, funds allocation, data use agreements, and regulatory and clinical documents for all RDCRC participating clinical and research sites; to integrate and collaborate with the NIH’s Data Management and Coordinating Center (DMCC) cores to create and maintain data collection instruments, perform data cleaning, and establish data sharing standards and procedures for specimen collection, management and tracking; to facilitate monitor all proposed activities for the Career Enhancement Core, the Pilot/Feasibility Governance Core, Patient Advocacy Groups, and the External Advisory Committee; and integrate and collaborate with the NIH DMCC Engagement and Dissemination Cores to ensure RDCRC activities and accomplishments are communicated to key stakeholder groups. In addition to Dr. Fisher, the Administrative Core will consist of a clinical research coordinator responsible for regulatory and study site coordination; a clinical research project manager responsible for tracking project budgets and deliverables; and a data analyst and biostatistician team responsible for ensuring adherence to the data management plan and providing oversight for analysis planning and execution. The Administrative Core will be bolstered by the robust resources available within Children’s Hospital of Philadelphia’s Research Institute. Members of the core will work closely with each other, with RDCRC project and core leaders, and the members of the DMCC to ensure synergies within the components of the RDCRC and with the NIH Rare Disease Clinical Research Network.