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🛠️ Mason: [Protocol Amendment Rationale Drafter]#590

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fderuiter wants to merge 2 commits intomainfrom
genesis-architect-protocol-amendment-849603794454286691
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🛠️ Mason: [Protocol Amendment Rationale Drafter]#590
fderuiter wants to merge 2 commits intomainfrom
genesis-architect-protocol-amendment-849603794454286691

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💡 What
Added a new expert-level prompt template: protocol_amendment_rationale_drafter.prompt.yaml under prompts/clinical/medical_writing.

🎯 Why
Fills a critical gap in the clinical/medical_writing domain 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

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@fderuiter fderuiter marked this pull request as ready for review March 18, 2026 23:58
Copilot AI review requested due to automatic review settings March 18, 2026 23:58
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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 Drafter prompt YAML under prompts/clinical/medical_writing.
  • Generated/added the corresponding rendered prompt documentation page under docs/prompts/....
  • Updated prompt listings in overview.md and 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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Comment on lines +58 to +64
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."
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2 participants