The goal of the Johns Hopkins All Children’s Data Coordinating Center for Pediatric Multicenter Studies (DCC-PMCS, simplified to “DCC” throughout the rest of this document) is to provide study design, database design, statistical analysis plan development, data management, and analytic plan execution services and expertise for multicenter studies focused on child health and disease.

The DCC leadership and its senior advisors are experienced in review and execution of NIH DCC U-level awards and non-federal consortium grants/contracts for pediatric multicenter phase 3 clinical trials and prospective cohort studies. The DCC team provides systems and architecture including relational database structures with robust audit trail logging procedures, access restrictions at the user-level for data governance at the database, CRF or field level, and Standard Operating Procedures enhanced by work practice documentation for every phase of the research study related to DCC services (e.g., randomization schema, database editing and locking procedures, data export, and archival processes).

Led by a team comprised of a director, manager, and other key personnel, the DCC provides services that include:

• Study design consultation with a PhD-level Epidemiologist and Master’s-level Biostatisticians who work directly with investigators to ensure studies are designed with appropriate methodologies that meet the needs of the research aims/questions and are directly aligned with the data to be captured;

• Design and documentation/reporting of statistical analysis plans by a PhD-level Epidemiologist and Master’s-level Biostatisticians who work directly with study team members;

• Power and sample size calculations by a PhD-level Epidemiologist and Master’s-level Biostatisticians who work in collaboration with investigators to ensure the planned study is adequately powered to detect the anticipated effects based on research questions/aims and a priori statistical analysis plans;

• Design and implementation of relational database structure by the Database Design and Data Management team of the Health Sciences Research Informatics shared resource. Database Analysts assess each study for the appropriate database structure and work directly with investigators and the study team to provide adequate architecture congruent with the approved study protocol, and to program standing reports (see also data management services below);

• Case report form (CRF) development by database analysts with specific expertise in pediatric e-CRF construction based on best practices in the field of pediatric database design and in close collaboration with the study’s principal investigator and designees, experienced and SOCRA-certified pediatric clinical research coordinators/project managers in the Clinical Coordinating Center, and the study’s lead epidemiologist and biostatistician within the DCC to ensure a robust study design, protocol feasibility, optimal data capture, and rigorous statistical analyses and reporting;

• Data management services are provided by the Database Design and Data Management team of the Health Sciences Research Informatics shared resource and include testing, validating and optimizing data capture systems, monitoring and quality assurance checks for out of range values, automated reports to investigators and study team members (e.g., Trial Quality Monitoring Reports) providing up-to-date enrollment and retention rates, data completion rates and high level assessment of missing data structures, as well as collaboration with site-specific dedicated data entry personnel to ensure data accuracy, data completeness and integrity

• Prepare all SAP-specified analyses, tables, figures, and listings, along with methodological descriptions, in support of final study reports, presentations, and publications.

Investigators and Key Personnel

• Neil Goldenberg, M.D., Ph.D. (Co-Director) Professor of Pediatrics, JHU SOM; Associate Dean for Research at JHACH
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• Janet Holbrook, Ph.D. Professor of Epidemiology, JHU SPH; Johns Hopkins Center for Clinical Trials and Evidence synthesis; Co-Director, American Lung Association Airways Clinical Research Centers (ACRC) Data Coordinating Center
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• Collin Hovinga, Pharm.D. (external advisor and collaborating investigator) 
  Vice President of the Rare and Orphan Disease Programs at the Critical Path Institute overseeing C-Path’s Rare Disease Cures Accelerator-Data and Analytics Platform and the Critical Path for Rare Neurodegenerative Diseases public-private partnership.

• Doug Jabs, M.D., M.B.A.  Professor of Epidemiology, JHU SPH; Director, Center for Clinical Trials and Evidence Synthesis, JHU SPH
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• Meenakshi Devidas, Ph.D., M.B.A. (external advisor) Director, Global Analytics Unit; St. Jude Children’s Research Hospital

• Ernest Amankwah, Ph.D. Adjunct Associate Professor of Oncology 

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Additional team members:

• Nuredin Joehar, (Director of Clinical Data Strategy), M.B.A.\IT, PMP, CSM

• Jamie Fierstein, Ph.D (Epidemiologist)

• Maua Mosha (Sr. Biostatistician)

• Karly Anderson (Database Analyst)