clinical-study-designer
Clinical study design skill for medical device trials including IDE studies and post-market studies
npx skills add a5c-ai/babysitter --skill clinical-study-designer --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# Clinical Study Designer Skill ## Purpose The Clinical Study Designer Skill supports design of clinical studies for medical devices, including IDE studies, post-market studies, and registries, ensuring scientific rigor and regulatory acceptance. ## Capabilities - Study design selection (RCT, single-arm, registry) - Endpoint definition guidance - Sample size calculation (superiority, non-inferiority, equivalence) - Protocol template generation - Informed consent template generation - CRF design assistance - Statistical analysis plan development - Randomization strategy - Blinding methodology - Interim analysis planning - Adaptive design support ## Usage Guidelines ### When to Use - Designing clinical trials - Calculating sample sizes - Developing protocols - Planning statistical analyses ### Prerequisites - Clinical objectives defined - Target population identified - Comparator strategy determined - Regulatory pathway established ### Best Practices - Select design appropriate for objectives - Ensure adequate statistical power - Plan for missing data - Include clinically meaningful endpoints ## Process Integration This skill integrates with the following processes: - Clinical Study
- Purpose
- Capabilities
- Usage Guidelines
- When to Use
- Prerequisites
- Best Practices
- Process Integration
- Dependencies
- Configuration
- Output Artifacts
- Quality Criteria
What does the clinical-study-designer skill do?
Clinical study design skill for medical device trials including IDE studies and post-market studies
How do I install it?
Run `npx skills add a5c-ai/babysitter --skill clinical-study-designer --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From a5c-ai/babysitter, a repository with 1,642 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.