validate_trial_report

Checks Clinical Study Reports (CSR) for ICH-E3 compliance.

Skills
Scientific
0

What it does and how to use it

A skill that teaches Claude Code to do scientific tasks well. It is packaged knowledge the model uses whenever it is relevant.

Install the skill (command above).
In Claude Code, describe what you need - the skill turns on by itself when the context fits.
No commands to memorize: you talk in plain language and the skill does the rest.

Install (Claude Code)

mkdir -p .claude/skills/validate-trial-report && curl -fsSL https://doutorai.pt/data/lib/skills__validate-trial-report.md -o .claude/skills/validate-trial-report/SKILL.md

Paste this command into the terminal, in your project folder, and the component installs automatically.

Content

#!/usr/bin/env python3
"""
Validate clinical trial reports against ICH-E3 structure.

Checks Clinical Study Reports (CSR) for ICH-E3 compliance.

Usage:
    python validate_trial_report.py <csr_file.md>
"""

import argparse
import json
import re
from pathlib import Path


ICH_E3_SECTIONS = {
    "title_page": "Title Page",
    "synopsis": "Synopsis (2)",
    "toc": "Table of Contents (3)",
    "abbreviations": "List of Abbreviations (4)",
    "ethics": "Ethics (Section 2)",
    "investigators": "Investigators and Study Administrative Structure (Section 3)",
    "introduction": "Introduction (S

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