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ClaudSkills / Science & Research / biology-medicine

Adverse Event Reporting Policy

Category: Science & Research  ·  Sub-category: biology-medicine  ·  Last updated:
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.

About this skill (catalog notes)

Adverse Event Reporting Policy includes a dedicated installation section. At roughly 1,974 words the SKILL.md is on the longer end of the catalog distribution.

License
Apache-2.0
Original author
CaseMark
Indexed lastmod
Catalog position
Science & Research · biology-medicine
Indexed related skills
10

How Adverse Event Reporting Policy fits the catalog

Adverse Event Reporting Policy sits in the Science & Research category under the biology-medicine sub-topic in the ClaudSkills catalog. There are 10 related skills indexed alongside it; comparing a few before installing usually reveals which fits your workflow best.

These notes are auto-generated from features detected in the SKILL.md file and from this catalog's structure — they aren't part of the source repository.

From the source SKILL.md

Drafts a binding AE reporting policy meeting FDA requirements and ICH standards for pharma, biotech, CROs, and healthcare organizations conducting or sponsoring clinical research.

What this skill does

Adverse Event Reporting Policy is a community-contributed Claude Code skill in the biology-medicine sub-category. It ships as a SKILL.md file that Claude Code auto-discovers under ~/.claude/skills/adverse-event-reporting-policy/ and loads when your prompt matches the skill's trigger.

When to invoke it: 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.

Who uses this skill

The Adverse Event Reporting Policy Claude Code skill is built for researchers, data scientists, academics, and analysts working with complex data and scientific literature. It's part of ClaudSkills (also referred to as Claude Skills or Claude Code Skills) — the open community-curated registry of 93,000+ SKILL.md files for Anthropic's Claude Code agent and the wider Claude ecosystem (Claude API, Claude Agent SDK).

How to install

Free

Manual install (2 steps)

mkdir -p ~/.claude/skills/adverse-event-reporting-policy
curl -L https://claudskills.com/skills/adverse-event-reporting-policy/SKILL.md \
  -o ~/.claude/skills/adverse-event-reporting-policy/SKILL.md

Or just download SKILL.md directly and drop it into ~/.claude/skills/adverse-event-reporting-policy/. Claude Code auto-discovers it on next session.

Skills live at ~/.claude/skills/adverse-event-reporting-policy/SKILL.md on macOS/Linux, or %USERPROFILE%\.claude\skills\adverse-event-reporting-policy\SKILL.md on Windows. See the full install guide for step-by-step instructions.

Telegram

📱 Install from your phone or desktop Telegram

Open @claudskills_bot on Telegram, tap Open Desktop App, and the desktop app installs this skill for you. Or share the bot link with a colleague — they get the same one-tap install. Learn more →

Pro

One-click install via the desktop app

The ClaudSkills desktop app installs any skill directly into ~/.claude/skills/ with one click — no terminal required. Pro starts at $9/mo or $149 lifetime.

Pro

For the full experience including quality scoring and one-click install features for each skill — upgrade to Pro.

Frequently asked questions

How do I install the Adverse Event Reporting Policy Claude Code skill?
Install via the ClaudSkills desktop app (one click) or copy SKILL.md from the source repository to ~/.claude/skills/adverse-event-reporting-policy/SKILL.md and restart Claude Code. Both flows are detailed at claudskills.com/install/.
What does the Adverse Event Reporting Policy skill do?
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.
Is this skill free to install?
Yes. ClaudSkills is an open registry — every skill keeps its source repository's license, and manual install via copy is free. ClaudSkills Pro ($9/mo, $79/yr, or $149 one-time) adds one-click install via the desktop app and a multi-signal Quality Score.
When should I use the Adverse Event Reporting Policy skill?
Use Adverse Event Reporting Policy when your Claude Code task falls under the Science & Research category — specifically in the biology medicine area. Claude Code auto-discovers installed skills and invokes the right one based on the task description, so you can also ask Claude directly (e.g. "use Adverse Event Reporting Policy" or describe the task and let Claude pick). Browse related skills at /category/science/.
What is a Claude Code skill and how does the Adverse Event Reporting Policy skill fit in?
A Claude Code skill is a SKILL.md file that lives under ~/.claude/skills/<name>/ and tells the Claude Code CLI agent how to perform a specific task (instructions, prompts, allowed tools). Skills are auto-discovered at session start. Adverse Event Reporting Policy is one of 67,000+ skills indexed in the open ClaudSkills catalog, classified under the Science & Research category. Learn more at /learn/what-is-a-claude-skill/.

Attribution & license

Cite this skill

If you reference this skill in a blog post, paper, or documentation, you can cite it as:

APA
CaseMark. (2026). Adverse Event Reporting Policy [Claude Code skill]. ClaudSkills. https://claudskills.com/skills/adverse-event-reporting-policy/
BibTeX
@misc{adverse-event-reporting-policy-2026,
  author    = {CaseMark},
  title     = {Adverse Event Reporting Policy [Claude Code skill]},
  year      = {2026},
  publisher = {ClaudSkills},
  url       = {https://claudskills.com/skills/adverse-event-reporting-policy/}
}

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