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Informed Consent Form Clinical Trial

Category: General  ·  Sub-category: general-misc  ·  Last updated:
Drafts an IRB-ready Informed Consent Form (ICF) for FDA-regulated clinical trials compliant with 21 CFR 50.25, 50.27, and ICH-GCP. Use when drafting or revising consent documents for Phase I–IV trials, IND studies, or other FDA-regulated protocols requiring IRB submission.

About this skill (catalog notes)

Informed Consent Form Clinical Trial includes a dedicated installation section. The SKILL.md runs to about 822 words, in the catalog's typical mid-range.

License
Apache-2.0
Original author
CaseMark
Indexed lastmod
Catalog position
General · general-misc
Indexed related skills
10

How Informed Consent Form Clinical Trial fits the catalog

Informed Consent Form Clinical Trial sits in the General category under the general-misc 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

Produces a plain-language ICF (≤ 8th-grade reading level) covering all 21 CFR 50.25 required elements, HIPAA authorization, and ethics-compliant framing for research subjects.

What this skill does

Informed Consent Form Clinical Trial is a community-contributed Claude Code skill in the general-misc sub-category. It ships as a SKILL.md file that Claude Code auto-discovers under ~/.claude/skills/informed-consent-form-clinical-trial/ and loads when your prompt matches the skill's trigger.

When to invoke it: Use when drafting or revising consent documents for Phase I–IV trials, IND studies, or other FDA-regulated protocols requiring IRB submission.

Who uses this skill

The Informed Consent Form Clinical Trial Claude Code skill is built for Claude Code users and developers across all disciplines looking for general-purpose AI assistance. 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/informed-consent-form-clinical-trial
curl -L https://claudskills.com/skills/informed-consent-form-clinical-trial/SKILL.md \
  -o ~/.claude/skills/informed-consent-form-clinical-trial/SKILL.md

Or just download SKILL.md directly and drop it into ~/.claude/skills/informed-consent-form-clinical-trial/. Claude Code auto-discovers it on next session.

Skills live at ~/.claude/skills/informed-consent-form-clinical-trial/SKILL.md on macOS/Linux, or %USERPROFILE%\.claude\skills\informed-consent-form-clinical-trial\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 Informed Consent Form Clinical Trial Claude Code skill?
Install via the ClaudSkills desktop app (one click) or copy SKILL.md from the source repository to ~/.claude/skills/informed-consent-form-clinical-trial/SKILL.md and restart Claude Code. Both flows are detailed at claudskills.com/install/.
What does the Informed Consent Form Clinical Trial skill do?
Drafts an IRB-ready Informed Consent Form (ICF) for FDA-regulated clinical trials compliant with 21 CFR 50.25, 50.27, and ICH-GCP. Use when drafting or revising consent documents for Phase I–IV trials, IND studies, or other FDA-regulated protocols requiring IRB submission.
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 Informed Consent Form Clinical Trial skill?
Use Informed Consent Form Clinical Trial when your Claude Code task falls under the General category — specifically in the general misc 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 Informed Consent Form Clinical Trial" or describe the task and let Claude pick). Browse related skills at /category/general/.
What is a Claude Code skill and how does the Informed Consent Form Clinical Trial 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. Informed Consent Form Clinical Trial is one of 67,000+ skills indexed in the open ClaudSkills catalog, classified under the General 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). Informed Consent Form Clinical Trial [Claude Code skill]. ClaudSkills. https://claudskills.com/skills/informed-consent-form-clinical-trial/
BibTeX
@misc{informed-consent-form-clinical-trial-2026,
  author    = {CaseMark},
  title     = {Informed Consent Form Clinical Trial [Claude Code skill]},
  year      = {2026},
  publisher = {ClaudSkills},
  url       = {https://claudskills.com/skills/informed-consent-form-clinical-trial/}
}

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