review-company-core-data-sheet

Solid

Reviews the clinical pharmacology content of a Company Core Data Sheet (CCDS) — the sponsor's internal reference document that anchors all regional label variants. Checks that CP content is consistent with the authoritative evidence base, that it can support downstream regional labels (USPI, SmPC, JP PI), and that content differences between CCDS and regional labels are documented rather than silent. Use when reviewing a CCDS draft. Do not use for regional label review or for deciding what content to include.

Code & Development 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

# Company Core Data Sheet CP Content Review Company core data sheet — produce a source-linked finding register a qualified reviewer can act on. Every finding carries a locator, a severity, and a detection path. The register arrives open; only a named human may close an item. > **Skills review, reconcile, verify, structure and flag. Qualified humans > decide, approve, sign off, submit and act.** ## Who this is for Clinical pharmacology or pharmacometrics practitioners working in **Product information** who need a bounded, repeatable review of this L3 task — not a decision, not a draft to submit, and not a substitute for the accountable human owner. ## When to use this skill - "Review the CP sections of our CCDS" - "Is the CCDS consistent with our current evidence base?" - "Check whether the CCDS supports the Section 12 content in our USPI" ## When NOT to use this skill These are close neighbours. Route them elsewhere and say so: | Request | Why not this skill | Where it belongs | |---|---|---| | Review the USPI | Regional label | review-uspi-section-12-content | | Review the SmPC | Regional label | review-eu-smpc-cp-sections | | Review the JP PI | Regional label | review-japan-package-insert-sections-9-10-16 | | Decide what the CCDS should say | A content decision | Labelling owner | ## Required inputs Ask for these by artifact, not by category. If one is missing, say which check it disables rather than proceeding silently. | # | Input | Form | Role | |---|---|---|...

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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