reconcile-reference-safety-information
SolidCompare supplied CCDS, CCSI, RSI, periodic-report, and regional-label reference safety lists and versioned change records, preserving list divergence with both locators. Use when a clinical pharmacologist or safety/labeling reviewer needs a mechanical reconciliation of reference safety information. Example: "Reconcile the CCDS, RSI and regional-label safety lists and preserve every divergence with locators." Do not use to decide whether a discrepancy requires a local label or RSI change, author binding label language, determine filing obligations, or characterise a safety signal.
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Quality Score: 84/100
Skill Content
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
reconcile-cross-document-facts
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.
reconcile-dsur-annual-report-coverage
Compares declared reporting periods across Development Safety Update Reports (DSURs) and US IND annual reports, flagging calendar gaps, same-format overlaps, and potential cross-format duplicate coverage while preserving the source status of every period. Use this skill when a regulatory or safety reviewer asks which reporting dates are covered, whether successive periodic reports leave a gap, or where a DSUR and an IND annual report cover the same dates. Example: "Please a regulatory or safety reviewer asks which reporting dates are covered." Do not use it to decide whether a DSUR satisfies 21 CFR 312.33, whether an IND filing obligation is met, or whether a safety conclusion is adequate.
spec-reconcile
Reconcile objective contradictions among accumulated specs, current truth, ADRs, and optional implementation evidence in Codex.