oversee-nca-dual-control-qclisted

Establishes whether an NCA quality-control pass was structurally sound, rather than assuming it from the words dual control. It classifies independence on an explicit scale - same script rerun through to different software entirely - and records whether the checker saw the primary results first, expresses scope as denominators of parameters, subjects and pipeline stages covered, and flags discrepancies resolved by the primary analyst alone, which returns the deliverable to single control exactly when dual control mattered. Use it to set up or review dual-control arrangements, assess CRO QC documentation, or build the oversight record. Example: "Please set up or review dual-control arrangements, assess CRO QC documentation." Do not use for verifying NCA parameters, for data-handling rules, for bioanalytical data quality, or to accept the deliverable.
malekokour/clinpharm-pmx-skills · ★ 6 · Data & Documents · score 77

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

# NCA dual-control oversight ## Who this is for The clinical pharmacologist accountable for an NCA deliverable produced by someone else — an internal analyst, a CRO, or a partner — who needs the independence of the check established rather than assumed. ## When to use this skill - Setting up or reviewing dual-control arrangements for an NCA deliverable. - Checking that an independent recomputation was genuinely independent. - Reviewing a CRO's QC documentation before accepting a deliverable. - Establishing what a QC pass did and did not cover. - Preparing the oversight record for a deliverable you will be accountable for. ## When NOT to use this skill - **Verifying the NCA parameters themselves** — use `verify-nca-outputs`. That skill performs the check; this one establishes whether the check was structurally sound. - **Data-handling rules** — use `review-blq-and-time-deviation-rules`. - **Bioanalytical data quality** — use `review-bioanalytical-report`. - **Accepting the deliverable.** Refused here — acceptance is the accountable human's. ## Operating modes | Mode | Question it answers | Minimum inputs | |---|---|---| | `INDEPENDENCE` | Was the second check actually independent? | QC documentation | | `SCOPE` | What did the QC cover, and what did it not? | QC documentation | | `RESOLUTION` | How were discrepancies resolved, and by whom? | QC records, discrepancy log | | `RECORD` | Is the oversight defensible in reconstruction? | full QC package | ## Procedure ###