Clinical Trial Protocol Generation

Turns a trial concept into an actual protocol DOCUMENT, grounded in real precedent-trial and regulatory-database lookups plus a genuine statistical sample-size calculation.

This skill is a downstream step, not a replacement for tooluniverse-clinical-trial-design. That skill answers "is this trial feasible, and what should endpoint/population/comparator/effect-size/duration/regulatory-pathway be?" (a 0-100 feasibility score with evidence grading). This skill takes those six answers — freshly run or already available from a prior tooluniverse-clinical-trial-design report — and drafts the actual protocol sections around them. Do not re-derive feasibility scoring, endpoint selection reasoning, or regulatory-pathway strategy here — call tooluniverse-clinical-trial-design for that and consume its output.

When to Use This Skill

• "Write me a clinical trial protocol for [drug/device]"
• "Generate an FDA submission protocol for our Phase 2 study"
• "Draft the statistical analysis plan / sample size section"
• "I have the feasibility assessment — now turn it into a protocol document"
• "What sample size do I need for a [proportion/continuous/survival] endpoint?"

NOT for (use other skills instead)