Presentation (CTI)

OBJECTIVES: Evaluate whether eCOA training strategies and materials sufficiently prepare sites to support patient completion of PRO assessments within clinical trial ecosystems.
METHODS: Training materials and approaches across multiple studies were reviewed for accuracy, completeness, consistency, workflow alignment, and use during site start-up and site initiation. Findings were interpreted alongside insights from stakeholder implementation discussions to assess how training strategy supports required site and patient behaviors.
RESULTS: Training materials frequently contained inaccurate or incomplete instructions, inconsistent terminology, missing context, and misalignment across materials developed by different stakeholders. Quick-reference guides were useful in concept but often illustrated the same underlying problem: abbreviated materials intended to make training more accessible sometimes omitted or altered key information from full training materials, creating incorrect or misleading guidance for site use. More content was produced without sufficient harmonization or behavioral design to support required site and patient behaviors. Assessments across studies also showed that decisions about how, when, and by whom sites would be trained to use and support the eCOA ecosystem were often unresolved or embedded within broader initiation activities. Across sources, training tended to emphasize system functionality rather than preparing site staff to explain patient responsibilities, expectations, and importance within the trial, or to support the behaviors required for accurate PRO completion.
CONCLUSIONS: eCOA training risk is not solved by producing more materials alone. Effective training must be designed as a behavioral and execution strategy that prepares site staff and patients to perform and support required behaviors within the trial ecosystem. Training contributes to compliance only when it enables site staff and patients to understand, communicate, and carry out these behaviors as part of study execution. Improving compliance requires harmonized materials, earlier training strategy decisions, and training that aligns with how people—both site staff and patients—interpret and act on study requirements to support reliable data collection.