fhir4pharma: Digitalizing Clinical Trial Protocols with FHIR
Clinical trials rely heavily on the Schedule of Activities (SoAs), the detailed roadmap that dictates what data must be collected and precisely when. Traditionally, this roadmap is presented as a static, tabular chart within the study protocol. However, real-world research is rarely static. Patients miss visits, unexpected events occur, and complex study designs (like in oncology) require multiple treatment cycles and conditional branching.
