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数据与复现
RE
regulatory-drafter
维护者 FreedomIntelligence · 最近更新 2026年4月1日
Draft regulatory submissions: FDA, EMA, ICH document preparation.
原始来源
FreedomIntelligence/OpenClaw-Medical-Skills
https://github.com/FreedomIntelligence/OpenClaw-Medical-Skills/tree/main/skills/regulatory-drafter
- 维护者
- FreedomIntelligence
- 许可
- MIT
- 最近更新
- 2026年4月1日
技能摘要
来自 SKILL.md 的关键信息
核心说明
- This skill assists regulatory affairs professionals by automatically generating sections of Common Technical Document (CTD) ，面向 raw data 、 literature. It focuses on accuracy，traceability，、 adherence to FDA/EMA guidelines。
- Drafting CTD Sections：Automatically generate Module 2.4 (Nonclinical Overview) 或 Module 2.5 (Clinical Overview)。
- Citation Management：When you need to synthesize multiple PDFs into coherent narrative ，支持 inline citations。
- Audit Trails：When every claim must be traceable back to source document。
- Drafting CTD Sections：Automatically generate Module 2.4 (Nonclinical Overview) 或 Module 2.5 (Clinical Overview). Citation Management：When you need to synthesize multiple PDFs into coherent narrative ，支持 inline citations. * Audit Trails：When every claim must be traceable back to source document。
原始文档
SKILL.md 摘录
Core Capabilities
- Document Synthesis: Ingests clinical study reports (CSRs) and literature to write narrative text.
- Citation Linking: Inserts hyperlinks or references to the source material.
- Style Compliance: Adheres to eCTD formatting standards.
Workflow
- Ingest Data: Point the agent to a folder of source PDFs/Data.
- Draft: Run the drafter with a specific section target (e.g., "Nonclinical Overview").
- Review: The agent outputs a Markdown/Word draft with annotations.
Example Usage
User: "Draft the Nonclinical Overview based on the toxicology reports in ./data/tox."
Agent Action:
适用场景
- **Drafting CTD Sections**：Automatically generate Module 2.4 (Nonclinical Overview) 或 Module 2.5 (Clinical Overview)。
- **Citation Management**：When you need to synthesi。
不适用场景
- Do not rely on this catalog entry alone ，用于 installation 或 maintenance details。
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