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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​

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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​

SeverityDescription
CriticalMust be addressed before IND submission
MajorShould be addressed to avoid protocol amendments
MinorRecommended for best practices
InformationalEducational 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  • Inactive: Rule is deprecated or superseded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.