Clinical Trial Schedule of Activities Specification Using Fast Healthcare Interoperability Resources Definitional Resources: Mixed Methods Study.

ABSTRACT:

Background

Clinical research studies rely on schedules of activities (SoAs) to define what data must be collected and when. Traditionally presented in tabular form within study protocols, SoAs are critical for ensuring data quality, regulatory compliance, and correct study execution. Recent efforts, such as the Health Level 7 Vulcan SoA Implementation Guide, have introduced Fast Healthcare Interoperability Resources (FHIR) as a standard for representing SoAs digitally. However, current approaches primarily handle simple schedules and do not adequately capture complex requirements such as conditional branching, repeat cycles, or unscheduled events-features essential for many study designs, particularly in oncology.

Objective

This study aimed to extend SoA representation metho

SUBMITTER: Richardson A 

PROVIDER: S-EPMC12583939 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature