Generate a full clinical trial protocol document (ICH E6(R2)/FDA-style) for a drug or medical device, including background, objectives/endpoints, study design, population/eligibility, intervention details, assessment schedule, statistical analysis plan with sample-size justification, safety monitoring, and regulatory/ethical sections. Use when users say "generate a clinical trial protocol", "draft a protocol for [drug/device]", "write up the study design as a protocol document", "create an FDA submission protocol", "help me write section X of a trial protocol", or "calculate the sample size for this trial". Produces a stakeholder-ready Markdown deliverable, not a feasibility score.
87%
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Low
Low-risk findings worth noting
The skill exposes the agent to untrusted, user-generated content from public third-party sources, creating a risk of indirect prompt injection. This includes browsing arbitrary URLs, reading social media posts or forum comments, and analyzing content from unknown websites.
The required workflow uses tools like `search_clinical_trials` and `PubMed_search_articles` to ingest external trial and literature data where outsider-authored text can be encountered.
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