oversee-nca-dual-control-qc

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

Phase 1 — Establish independence

Entry: QC documentation located.

1. Record who produced the primary analysis and who performed the check, and confirm they are different people. Record it as a fact from the documentation, not an assumption from the process description.
2. Record whether the checker had access to the primary analyst's outputs before producing their own. A "recomputation" performed with the original results visible is a reconciliation, not an independent check, and the two are worth very different amounts.
3. Record whether the checker used the same software, the same script, and the same derived dataset. Independence degrades along each axis: a second run of the same script on the same dataset by a different person tests operator error and nothing else.
4. Classify the check on an explicit scale — same script rerun · independent script, same dataset · independent script and independent derivation · different software entirely. State which was achieved rather than describing the process as "dual control".