Clinical Data Management and Data Standards
Headed by Erin Crecelius, The Clinical Data Management & Standards team partners with the Sponsor Operations team to provide centralized data management for investigator-initiated treatment trials. Their services include:
- Electronic case report form (eCRF) development
- EDC database builds using FDA-supported CDASH standards
- Clinical data quality review and monitoring
- Reporting and analysis dataset generation
The team works closely with Principal Investigators and study teams to maintain high data quality throughout the entire trial lifecycle.
The group includes Clinical Data Management Associates (CDMAs), an eCRF Developer, and an SDTM Programmer. CDMAs are assigned to studies based on research pods, while the eCRF Developer and SDTM Programmer provide support across all trials managed by the Clinical Trials Office (CTO).
Clinical Trial Systems and Reporting
Headed by Mary O’ Dwyer, the Clinical Trial Systems & Reporting team administers and supports several key clinical trial platforms, including:
- OnCore
- Advarra EDC
- Florence eBinder
These systems integrate with Epic and other institutional platforms to support regulatory, clinical, financial, and sponsor operations. When applicable, they also support compliance with 21 CFR Part 11 requirements for FDA-regulated records. The team also:
- Supports internal leadership, research funders, and public reporting needs
- Manages ClinicalTrials.gov registration and results reporting for Lineberger-sponsored investigator-initiated trials
- Produces data, analytics, dashboards, and operational reports