OnCore CTMS Protocol and Subject Data Migration
Our client, a Cancer Consortium, had been working on implementing a CTMS for a few years. The initial goal was to streamline and centralize processes across multiple institutions, improve tracking and reporting, for protocol, review, and subject data. Although work had been in progress, the pace, as well as the strategy was insufficient to meet the goal to have in place prior to an upcoming National Cancer Institute (NCI) Cancer Center Support Grant (CCSG) renewal.
A critical success factor for this project was the successful migration of protocols and subjects from various source systems. Our client reached out to us for a candidate that would bring the necessary project management leadership, as well as the analytical and technical capabilities required for the migration. At the time our consultant was brought on, there was very little in place regarding design decisions, tools, or processes, but a deadline was quickly approaching.
Our consultant quickly assessed the situation and developed a Data Migration Strategy, Plan and Approach which outlined a path forward. This plan brought many important components together to form a cohesive strategy that allowed for executive leadership visibility, organization, and accountability. It included our required minimum footprint (MFP), source data fields including mapping and translations to MFP, necessary pre migration data prep, post migration clean-up, a quality assurance plan, and finally automated data migration tools (data migration macros using excel and python scripting), a migration team, and processes to meet the deadline.
Coordinating communication and data validation across over 60 teams, the Ballista Consultant managed a team upward of 10 individuals to assist with technical components, data review and entry, and quality assurance. Successfully and on time, over 3000 protocols and 45,000 subjects were migrated meeting the requirements for the Cancer Consortium’s reporting needs. Additionally, the IRB reviews, DSMC/DSMB reviews, SRC approvals, and Investigational Drug/Device data for the 3000 protocols were also migrated to further meet regulatory and reporting requirements.