clinical_trial_reporting

The International Council for Harmonisation (ICH) E3 guideline defines the structure and content of clinical study reports (CSRs) for regulatory submission.

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/clinical-trial-reporting && curl -fsSL https://doutorai.pt/data/lib/skills__clinical-trial-reporting.md -o .claude/skills/clinical-trial-reporting/SKILL.md

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

Content

# Clinical Trial Reporting Standards

## ICH-E3: Structure and Content of Clinical Study Reports

The International Council for Harmonisation (ICH) E3 guideline defines the structure and content of clinical study reports (CSRs) for regulatory submission.

### CSR Overview

**Purpose:**
- Provide comprehensive description of study design, conduct, and results
- Support regulatory decision-making
- Document evidence of safety and efficacy

**Audience:**
- Regulatory authorities (FDA, EMA, PMDA, etc.)
- Medical reviewers
- Statistical reviewers
- Clinical pharmacology reviewers

**Length:** Typic

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