oversee-nca-dual-control-qc

Solid

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.

Data & Documents 6 stars 0 forks Updated 6 days ago MIT

Install

View on GitHub

Quality Score: 84/100

Stars 20%
28
Recency 20%
100
Frontmatter 20%
70
Documentation 15%
100
Issue Health 10%
80
License 10%
100
Description 5%
100

Skill Content

# 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 ###...

Details

Author
malekokour
Repository
malekokour/clinpharm-pmx-skills
Created
1 weeks ago
Last Updated
6 days ago
Language
Python
License
MIT

Similar Skills

Semantically similar based on skill content — not just same category

Code & Development Solid

review-blq-and-time-deviation-rules

Reviews the data-handling rules that determine what an analysis dataset contains - BLQ method, actual-versus-nominal times, and exclusions. It records the censored proportion alongside the BLQ method because the choice only matters in proportion to it, checks the quantification limit in the plan against the bioanalytical report, requires sampling and dosing deviations to be handled by distinct rules, classifies each exclusion by whether it can be applied without seeing the result, and reconciles collected minus excluded against analysed. Use it for an analysis plan before derivation, or afterwards to establish what was actually applied. Example: "Please an analysis plan before derivation." Do not use for NCA parameter verification, for NCA dual-control oversight, for the modelling plan as a whole, for assay validation, or to decide which handling method is correct.

6 Updated 6 days ago
malekokour
Testing & QA Listed

cx-control-testing

Use to test whether a support control actually operates, the way an auditor would test it, rather than confirming it exists on paper. Trigger for "test our controls", "does this control actually work", second-line assurance over support, control effectiveness testing, preparing for an internal audit, or a control that passed review and then failed in practice.

1 Updated 2 weeks ago
rulebase-co
AI & Automation Listed

linmas-controls-compliance-reviewer

Controls and compliance review skill for evidence review, control mapping, audit preparation, and framework gap analysis.

2 Updated 1 months ago
TanKimGwan