prepare-safety-committee-exposure-input

# 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...