majiayu000 Regulatory Document Drafter
This skill generates compliant drafts for regulatory submissions, emphasizing auditability and adherence to guidelines (ICH, FDA).
When to use this skill
- When asked to write sections of an IND, NDA, or CSR (Clinical Study Report).
- When responding to "Request for Information" (RFI) from health authorities.
- When the user requires "reasoning" or "thinking" to be visible (Anthropic style).
How to use it
- Analyze Context:
- Identify the specific regulatory document type (e.g., "Module 2.5 Clinical Overview").
- Retrieve relevant guidelines (e.g., "FDA Draft Guidance on X").
- Thinking Block (Internal Monologue):
- Before writing, outline the strategy in a
<thinking>block. - Assess potential risks or claims that require citation.
- Before writing, outline the strategy in a
- Drafting:
- Use formal, objective regulatory language (e.g., "The data suggest..." instead of "We proved...").
- Insert placeholders for data references
[Link to Table 14.2.1].
- Audit Trail:
- Append a "Compliance Check" section listing which guidelines were consulted.