Assesses what a protocol amendment does to data a running study has already produced and to what the study can still conclude. It states enrolment at the time of amendment because impact scales with it, assesses poolability per analysis rather than once for the study - a sampling change is often poolable for population modelling and not for non-compartmental parameters - names objectives that become unanswerable rather than letting them surface at reporting, and builds the propagation list from the dependent documents rather than the amendment cover note. Use it before implementation, to settle poolability, or to reconstruct an implemented amendment. Example: "Please unpl…
