reconcile-dsur-annual-report-coverage

Solid

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.

AI & Automation 6 stars 0 forks Updated 6 days ago MIT

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Quality Score: 84/100

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Skill Content

# DSUR and Annual Report Coverage Reconciliation Build a source-located register of the periods declared by DSURs and US IND annual reports. Flag gaps and overlaps mechanically. Preserve, but never settle, the two live US-policy unknowns that motivated this workflow. **This skill reconciles dates. It never determines whether an IND filing obligation is satisfied.** ## Intended users and repeatable outcome Use this workflow for a clinical pharmacologist working with a regulatory safety reviewer to produce: 1. a document-period inventory with exact source locators; 2. same-format gap and overlap findings; 3. cross-format overlap findings labelled as potential duplicate coverage; 4. a list of records that could not be assessed; 5. both unresolved policy questions, visibly `UNKNOWN`; and 6. a draft human-review record with every disposition left `open`. ## Activate for - “Compare the DSUR and IND annual-report periods and flag uncovered dates.” - “Do these two successive DSURs overlap?” - “Which dates appear in both the DSUR and the annual report?” - “Reconcile our periodic-report calendar before the regulatory safety review.” ## Do not activate for | Request | Route | |---|---| | Decide whether a DSUR legally replaces an IND annual report | Regulatory counsel or the accountable regulatory owner must verify current primary authority | | Check DSUR section completeness or characterise safety signals | A qualified safety workflow; this skill reads period metadata only | | ...

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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