assess-protocol-amendment-impactlisted

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 unplanned deviations, sampling schedule adequacy, analysis plan amendments specifically." Do not use for unplanned deviations, sampling schedule adequacy, analysis plan amendments specifically, or to approve the amendment.
malekokour/clinpharm-pmx-skills · ★ 6 · Data & Documents · score 77

Install: claude install-skill malekokour/clinpharm-pmx-skills

# Protocol amendment impact assessment ## Who this is for A clinical pharmacologist assessing what a protocol amendment does to the data a running study has already produced, and to what the study will be able to conclude. ## When to use this skill - Assessing a proposed amendment before it is implemented. - Establishing whether data before and after an amendment can be pooled. - Reviewing an amendment's effect on the analysis plan and the objectives. - Reconstructing, after the fact, what an implemented amendment changed. - Preparing the clinical pharmacology position on an amendment for governance. ## When NOT to use this skill - **Deviation and compliance impact** — use `review-study-conduct-pk`. A deviation is unplanned; an amendment is deliberate, and the analysis differs. - **Sampling schedule adequacy** — use `review-pkpd-sampling-schedule`. - **Analysis plan amendments specifically** — use `review-pk-analysis-plan`, which handles the unblinding-timing question those carry. - **Approving the amendment.** Refused. ## Operating modes | Mode | Question it answers | Minimum inputs | |---|---|---| | `POOLABILITY` | Can pre- and post-amendment data be analysed together? | current and proposed protocol | | `OBJECTIVES` | What can the study still conclude? | protocol, objectives, enrolment status | | `PROPAGATION` | What else must change? | protocol, analysis plan, other documents | | `RECONSTRUCT` | What did an implemented amendment actually change? | protocol ver