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Clinical Reports Drafting

Builds safety-bounded draft structures for clinical, trial, and safety reports and runs offline deterministic checks on structure and provenance.

Docs & OfficeAdvanced33,0303,248AI score 9/10Last updated: Aug 9, 2026

What it does

  • Routes each artifact to the correct reporting guidance: CARE 2013 for case reports, ACR/CAP/CLIA boundaries for diagnostic scaffolds, CONSORT 2025 for trial results, SPIRIT 2025 for protocols, ICH E3 for CSRs, and ICH E2A/E2B(R3)/E2D(R1) for safety reporting.
  • Generates blank, fail-closed JSON templates from assets/ and requires every populated field to trace back to a verified source-fact ID in a provenance manifest.
  • Runs dependency-free, offline Python scripts to check CARE structure, trial-report structure, aggregate adverse-event tables, terminology schemas, de-identification process documentation, traceability, and internal consistency.
  • Hard-blocks diagnosis, treatment or dosing advice, image/lab interpretation, causality or reportability decisions, signing, filing, and any use of real PHI; every output keeps a "DRAFT — not for clinical use or submission" banner.

Who it's for

  • Medical writers and researchers preparing case reports or journal manuscripts
  • Clinical research and regulatory staff scaffolding trial results reports, protocol reporting checks, or CSR drafts
  • Pharmacovigilance and data teams assembling aggregate safety tables and de-identification documentation

Examples

  1. Run python3 scripts/generate_report_template.py --type case-report --output ./case-report-draft.json, populate only verified facts, then run validate_case_report.py to surface missing CARE items.
  2. Feed an aggregate AE CSV plus metadata to format_adverse_events.py to produce a Markdown table that states denominators and missingness explicitly.
  3. Check a randomized-trial manuscript skeleton against CONSORT 2025, then run provenance_validator.py and consistency_checker.py before handing off to statistical and safety reviewers.

· · · Install guide · · ·

Try it now, no install

Paste this into Claude to use the skill without installing anything.

Read the instructions in this file and follow them to help me:
https://raw.githubusercontent.com/K-Dense-AI/scientific-agent-skills/HEAD/skills/clinical-reports/SKILL.md

What I want: (describe your task here)

If Claude can't open the link, open it yourself and paste the contents instead.

If it works for you, download the ZIP below and install it. Then it runs on its own — no pasting each time.

Install in the Claude app (no terminal)
  1. Download the ZIP with the button below.
  2. In Claude, open Settings → Capabilities and turn on 'Code execution and file creation'. (one time)
  3. Go to Customize → Skills → + → 'Upload a skill' and upload the ZIP.
Download ZIP
Install in Claude Code

Let Claude do it — paste this into Claude Code

Install the skill I found on Claude Skill Mart.
Copy the skills/clinical-reports folder from the GitHub repo K-Dense-AI/scientific-agent-skills into my ~/.claude/skills/clinical-reports/.
When it's done, tell me in one line what this skill can do.

Install with a command instead

git clone https://github.com/K-Dense-AI/scientific-agent-skills.git && mkdir -p ~/.claude/skills && cp -r scientific-agent-skills/skills/clinical-reports ~/.claude/skills/

This is a third-party skill. Check the source repository before installing.

  1. Open your terminal.
  2. Clone the repository: git clone https://github.com/K-Dense-AI/scientific-agent-skills.git
  3. Create the skills folder: mkdir -p ~/.claude/skills
  4. Copy the skill: cp -r scientific-agent-skills/skills/clinical-reports ~/.claude/skills/
  5. Confirm Python 3.11+ is available for the optional scripts: python3 --version (no extra packages needed).
  6. Restart Claude Code and try a prompt like "Create a CARE-compliant case report draft structure."
  7. Use only synthetic, de-identified, or aggregate data with a verified source-fact manifest — never real patient records — and route every draft to qualified reviewers.