adverse-event-reporting-policy
Drafts an Adverse Event Reporting Policy compliant with 21 CFR 312.32 (IND safety reporting), 21 CFR 314.80 (postmarketing), and ICH E2A, with…
Skill by casemark
Chalk Labs
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Install
Works with Claude Code, Claude apps, Codex, Cursor, Gemini CLI, GitHub Copilot, VS Code, OpenCode, Goose, Windsurf. Read the repository before you give any tool access to your data.
npx agentmarket install skill/cslawyer1985-adverse-event-reporting-policy
Asks which of your tools to add it to (Claude Code, Codex, Cursor, VS Code, Windsurf, Gemini CLI, Claude Desktop) and shows the change first. See https://agentmart.dev/cli.
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About
Use cases: testing, research
Reviews
Write a reviewNo reviews yet. Installed it? Reviews come from verified installers only. How reviews work
Permissions
What this skill can do and what it asks for, from its SKILL.md. Checked Oct 25, 2026.
- Tools
- No tools found
- Secrets
- None asked for
- Install scripts
- None found
Network hosts it talks to 1
codeload.github.com· found in install command
Files it touches
~/.claude/skills/adverse-event-reporting-policy
What's inside
- Skill name
adverse-event-reporting-policy- Description
- 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.
- License
- unknown
- Metadata
- author: casemark
- Instructions
- 248 lines in SKILL.md · view on GitHub
Files (2)
- LICENSE.txt
- SKILL.md
The license isn't open source, so the instructions aren't shown here. Read SKILL.md on GitHub
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Signals
- Stars
- 21
- Forks
- 4
- Open issues
- 1
- Last commit (this folder)
- Aug 4, 2026 (2 months ago)
From GitHub (fetched Oct 24, 2026).
Details
- License
- License unknown
- Repository
- github.com/CSlawyer1985/legal-skillhub
- Website
- skill.chenshi.ai/
- First seen
- Oct 24, 2026
- Last checked
- Oct 24, 2026
- Source
- GitHubgithub-graphql
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adverse-event-reporting-policy skill. Agent Mart. https://agentmart.dev/skills/cslawyer1985-adverse-event-reporting-policy (last updated 2026-10-24)