Chapter 09 · the living feed
Notes · Clinical trials.
The feed of writing relevant to clinical-trials practice. ICH E6(R3) principles-based GCP, ICH M11 structured protocols, AI in trial design and conduct. Filtered from the global archive.
View global notes archive →2026-03-27
ICH M11 structured-protocol: how AI changes the trial design layer.
The structured protocol template is becoming machine-readable. What that means for AI-assisted trial design, regulator review, and the eTMF lifecycle.
ICH M11clinical trialsstructured protocol
~7 min
2026-02-27
ICH E6 R3 principles-based GCP: the spirit, not the checklist.
R3 (Jan 2025) reframed GCP from prescriptive rules to outcome-based principles. What that means for sponsors, monitors, and auditors who built their muscle on R2.
ICH E6 R3GCPclinical trials
~7 min