🛠️ Mason: [Protocol Amendment Rationale Drafter]#590
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Pull request overview
Adds a new expert prompt template in the clinical medical-writing domain for drafting rigorous rationales supporting clinical trial protocol amendments, and updates prompt indices/docs so it’s discoverable.
Changes:
- Added
Protocol Amendment Rationale Drafterprompt YAML underprompts/clinical/medical_writing. - Generated/added the corresponding rendered prompt documentation page under
docs/prompts/.... - Updated prompt listings in
overview.mdand global docs indices (TOC, index, clinical).
Reviewed changes
Copilot reviewed 6 out of 6 changed files in this pull request and generated 1 comment.
Show a summary per file
| File | Description |
|---|---|
| prompts/clinical/medical_writing/protocol_amendment_rationale_drafter.prompt.yaml | New prompt template (persona + required inputs + evaluators). |
| prompts/clinical/medical_writing/overview.md | Adds the new prompt to the medical-writing overview list. |
| docs/table-of-contents.md | Adds the new prompt doc page to the global TOC. |
| docs/prompts/clinical/medical_writing/protocol_amendment_rationale_drafter.prompt.md | New rendered documentation page for the prompt. |
| docs/index.md | Adds the new prompt doc page to the main docs index list. |
| docs/clinical.md | Adds the new prompt doc page to the clinical landing page list. |
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| testData: | ||
| - input: | ||
| amendment_summary: "Addition of a lower dose cohort (Cohort C) and modification of inclusion criteria to allow patients with mild renal impairment." | ||
| safety_signals: "Increased incidence of Grade 3 neutropenia in the original dose cohorts (A and B)." | ||
| scientific_objectives: "Explore efficacy at a reduced dose to optimize the therapeutic index; expand real-world applicability by including mild renal impairment." | ||
| ethical_considerations: "Reduces risk of severe toxicity for new enrollees. Requires re-consenting existing subjects regarding the newly identified risk profile." | ||
| regulatory_guidance: "ICH E4 Dose-Response Information to Support Drug Registration; FDA Guidance on Pharmacokinetics in Patients with Impaired Renal Function." |
💡 What
Added a new expert-level prompt template:
protocol_amendment_rationale_drafter.prompt.yamlunderprompts/clinical/medical_writing.🎯 Why
Fills a critical gap in the
clinical/medical_writingdomain for drafting comprehensive, scientifically rigorous rationales for clinical trial protocol amendments.📊 Impact
Provides an authoritative "Principal Medical Writer and Clinical Trial Strategist" persona to synthesize safety signals, scientific objectives, ethical considerations, and regulatory guidance into a structured, highly defensible rationale. The repository's documentation indices have also been updated to reflect the new addition.
PR created automatically by Jules for task 849603794454286691 started by @fderuiter