reconcile-cross-document-facts
SolidMaintains 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.
Install
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-reference-safety-information
Compare 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.
data-reconcile
Reconcile any two record sets (A vs B) and triage the discrepancies — match line-by-line on a shared key, or heuristically on amount + date, then classify every unreconciled item (category, materiality, probable cause, suggested action) into a reconciliation working paper (.xlsx). Use whenever the user wants to "reconcile A to B", "reconcile the bank to the ledger", "reconcile the invoice tracker to the accounts", "tie out", "match these two lists/exports", "find the differences between", "what doesn't match", "reconciliation working paper", or "discrepancy triage". Presets for common recurring reconciliations (invoice tracker vs accounting records, bank vs cashbook, fund administrator vs internal records, payments/PRF vs bank); generic for anything else. NOT budget/variance analysis, and NOT deal/asset analysis (that is out of scope).
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.