adverse-event-reporting-policy
adverse-event-reporting-policy is a Privacy & regulatory compliance skill for AI agents, published by CaseMark in the skills repository on GitHub. Skillspace rates adverse-event-reporting-policy D (59/100) and it passed the safety scan; the rating is based on static analysis only.
Drafts an Adverse Event Reporting Policy compliant with 21 CFR 312.32 (IND safety reporting), 21 CFR 314.80 (postmarketing), and ICH E2A, with multi-jurisdictional overlays (EMA, PMDA, Health Canada). Covers seriousness/causality frameworks, expedited reporting timelines, roles, documentation standards, training mandates, and QA mechanisms. Use when drafting or updating an adverse event reporting policy, pharmacovigilance policy, AE/SAE reporting SOP, or safety reporting framework for a pharmaceutical company, CRO, biotech, or clinical research institution.
- Grade
- D
- Quality
- 59 / 100
- Safety
- Passed
- GitHub stars
- 28
Unproven: rated by static analysis only, not yet compared head-to-head.
Our two independent classifiers differ on this skill's category, so treat the placement as provisional.
This rating describes the version of the repository we crawled; it may have changed since, so go by its current files.
Our review
- Architecture
- 84 / 100
- Maturity
- Basic: a single SKILL.md
- Security scan
- No issues found
- License
- Apache-2.0
- Adoption
- Adopted by 0 other repositories, in 1 collections
Not checked yet
- Not judged on the rubric yet (not a contender in its category)
- No blind task eval yet
- Scope (portable / vendor / repo-internal) not assessed; only the top of each category is read for scope
- Sibling files (scripts, references) not fetched; security scan covers SKILL.md only
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