Rules Registry

The Rules Registry provides a real-time view of all regulatory rules and guidelines available in CTWise. This data is dynamically fetched from the CTWise Regulatory Rules Service (RRS) Engine.

Live Rules Catalog

All Sources

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Understanding the Data

Tiers

• Tier 1 (Core Regulatory): Universal requirements from FDA, ICH, EMA, and WHO that apply to all clinical trials
• Tier 3 (Therapeutic Area): Specialized guidance for specific therapeutic areas like oncology, psychiatry, and rheumatology

Severity Levels

Severity	Description
Critical	Must be addressed before IND submission
Major	Should be addressed to avoid protocol amendments
Minor	Recommended for best practices
Informational	Educational guidance

Status

• Active: Rule is currently in effect and enforced
• Inactive: Rule is deprecated or superseded

API Access

Access the rules registry programmatically:

# List all sources
curl -s "https://api.ctwise.ai/v1/catalog/sources" \
  -H "X-Api-Key: YOUR_API_KEY" | jq '.'

# Search rules by keyword (GET method)
curl -s "https://api.ctwise.ai/v1/rules?source=fda_oncology&query=oncology&limit=10" \
  -H "X-Api-Key: YOUR_API_KEY" | jq '.'

# Semantic search (POST method - natural language queries)
curl -s -X POST "https://api.ctwise.ai/v1/semantic-search" \
  -H "X-Api-Key: YOUR_API_KEY" \
  -H "Content-Type: application/json" \
  -d '{"query": "oncology trial requirements", "sources": ["fda_oncology"]}' | jq '.'

See the API Reference for complete documentation.