prepare-safety-committee-exposure-inputlisted

Prepares the exposure contribution to a safety signal review - whether an event tracks exposure, and what the available data could have shown either way. It justifies the exposure metric against the event mechanism rather than defaulting, counts affected subjects lacking PK data and states the bias direction since those cases are usually the sickest, reports stratum event counts before any rate because a rising percentage across two three and four events is not a relationship, and reports the observed exposure range alongside any negative finding so no relationship observed is distinguished from could not have observed one. Use it for a signal review or periodic safety discussion. Example: "Please a signal review or periodic safety discussion." Do not use for escalation decision packs, for submission exposure-safety sections, for nonclinical margins, for committee documentation, or to judge causality or recommend a dose change.
malekokour/clinpharm-pmx-skills · ★ 6 · Code & Development · score 77

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

# Safety committee exposure input ## Who this is for A clinical pharmacologist asked what exposure has to say about a safety signal — for a safety committee, a signal review, or a benefit–risk discussion where the question is whether exposure explains anything. ## When to use this skill - Preparing the exposure contribution to a safety signal review. - Assembling exposure evidence for a periodic safety discussion. - Answering whether an observed event tracks exposure. - Establishing what exposure data can and cannot say about a signal. - Preparing exposure input where a dose change is being considered by others. ## When NOT to use this skill - **Escalation-decision packs** — use `prepare-escalation-committee-package`. That answers a dose-escalation question; this answers a signal question. - **Exposure–safety in a submission** — use `review-ctd-2734-exposure-safety`. - **Nonclinical margins** — use `review-exposure-safety-margins`. - **Committee documentation** — use `document-safety-committee-decisions`. - **Judging causality, or recommending a dose change.** Refused. Causality assessment belongs to pharmacovigilance and the accountable physician. ## Operating modes | Mode | Question it answers | Minimum inputs | |---|---|---| | `SIGNAL` | Does this event track exposure in the available data? | event data, exposure data | | `INDIVIDUAL` | What was the exposure in the affected subjects? | case data, exposure data | | `POWER` | Could this data have detected a relat