prepare-escalation-committee-packagelisted

Assembles the exposure content a safety or escalation committee decides from, derived from the governing rule rather than from whatever data happens to be available. It reports subjects dosed, evaluable, and with the parameter as three distinct denominators, presents every parameter with its precision at the current sample size, states the implication for the next dose level rather than leaving the committee to extrapolate from the current one, and makes what the pack cannot show a named section rather than a footnote. Use it to assemble or review an escalation pack before committee. Example: "Please assemble or review an escalation pack before committee." Do not use for the escalation design itself, for interim look permissions, for committee minutes, or to make or recommend the escalation decision.
malekokour/clinpharm-pmx-skills · ★ 6 · Code & Development · score 77

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

# Escalation committee package preparation ## Who this is for A clinical pharmacologist assembling the exposure data a safety or escalation committee will decide from — and who has to make sure the pack supports a decision rather than merely describing what happened. ## When to use this skill - Assembling the PK content of an escalation-committee pack. - Reviewing a pack before it goes to committee. - Checking that the pack answers the question the protocol says the committee must decide. - Establishing what the committee could not have known from the pack it received. - Preparing the exposure section for a safety review meeting. ## When NOT to use this skill - **The escalation design itself** — use `review-escalation-schema`. That reviews the rules; this assembles the data a decision under those rules needs. - **Interim look permissions** — use `review-interim-blinded-pk`. - **Committee documentation and minutes** — use `document-safety-committee-decisions`. - **Making or recommending the escalation decision.** Refused. This skill assembles and stops. ## Operating modes | Mode | Question it answers | Minimum inputs | |---|---|---| | `ASSEMBLE` | Is everything the decision requires present? | protocol rules, cohort data | | `SUFFICIENCY` | Can the committee decide from this? | pack, protocol rules | | `PREDICTION` | How does observed exposure compare with predicted? | cohort data, predictions | | `GAPS` | What will the committee not know? | pack | ## Procedure #