On our study build, we track informed consent form revisions like RFIs on a construction schedule and flag them in weekly timeline reports. Trivia for the group: which came first, the Belmont Report (1979) or ICH E6 GCP (1996), and which one tends to trigger more consent edits on your timelines?
Belmont came first — “Belmont 1979; ICH E6 1996” — and in my builds ICH E6(R2) plus local IRB templates drive more ICF edits than Belmont’s principles. I keep an annotated clause bank mapped to E6 and country regs so we can drop in pre-cleared text and save a review cycle; do your edits spike more from sponsor QA or from the IRB?