reconcile-dsur-annual-report-coveragelisted
Install: claude install-skill malekokour/clinpharm-pmx-skills
# 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 |
|