FDA PRO guidance treats a patient-reported outcome instrument as validated evidence. Any change to the wording, the response set, the skip logic, or the scoring rule is a change to the evidence trail, and the regulator expects a version…
Category: Digital forms
1 min read
0
SDC Form Building: 5 Best Practices for Clinical Forms
SDC-based clinical form building follows five practices in production. 1. Item-to-StructureDefinition linkage. Every item references […]