reconcile-cross-document-facts

Solid

Maintains a register of clinical pharmacology values and claims across a programme's document thread — protocol, CSR, Module 2.7.2, briefing documents and label — and supports bounded privacy structure, ethics-submission, topline snapshot, and PD/biomarker context tracing. Use when a request spans documents or studies over time, asks where a changed value propagates, or traces declared PD/biomarker fields, synthetic privacy structures, ethics records, or topline facts across a programme. Example: "Where does this changed clearance value propagate across the CSR, Module 2.7.2 and the draft label?" Do not use for participant records, legal/privacy compliance, ethics approval or response adequacy, checking one report against its own outputs, verifying an analysis, drafting source documents, clinical meaning, causality, benefit-risk, disclosure wording, commitments, or deciding which conflicting value is correct.

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

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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

# Cross-Document Fact Reconciliation Maintain a register of the clinical pharmacology values and claims that travel along a programme's document thread — protocol, CSR, Module 2.7.2, briefing documents, health-authority responses, label — and reconcile each new or revised document against a baselined source-version record. Produce a register in which every fact carries its origin, every restatement carries its locator, and every conflict carries both sides — for a qualified clinical pharmacologist to disposition. **This skill reconciles and traces. It never edits a document, reruns an analysis, or decides which of two conflicting values is correct.** ## Who this is for Clinical pharmacology leads holding a programme's numbers together across studies · regulatory-facing CP reviewers preparing a submission or a meeting package · document owners who need to know what a changed source value breaks downstream. ## When to use this skill Use when the object is the **thread**, not a single document — several documents, often several studies, usually several versions in time: - "Reconcile the dose rationale across protocol, CSR, 2.7.2 and label" - "Does the clearance in the proposed label still match the CSR it came from?" - "We reran the NCA on Study 102 — what downstream documents restate those values?" - "Track every place we have stated the food-effect result, and when we stated it" - "Before this briefing package goes out, check nothing contradicts what we already told the...

Details

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

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