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Content Catalog

CTWise aggregates regulatory guidance and requirements from multiple authoritative sources to provide comprehensive clinical trial compliance coverage.

Data Architecture​

CTWise organizes regulatory content into three tiers:

Tier 1: Core Regulatory Requirements​

Universal requirements that apply to all clinical trials regardless of therapeutic area:

  • FDA Guidance Documents - U.S. Food and Drug Administration regulatory guidance
  • ICH Guidelines - International Council for Harmonisation (GCP, E6/E8/E9)
  • EMA Guidance - European Medicines Agency requirements
  • WHO Guidelines - World Health Organization clinical trial standards

Tier 3: Therapeutic Area Specific​

Requirements specific to therapeutic areas:

  • FDA Oncology Guidance - FDA Oncology Center of Excellence guidance for cancer clinical trials
  • FDA Psychiatry Guidance - Guidance for psychiatric and CNS clinical trials
  • FDA Rheumatology Guidance - Guidance for rheumatology clinical trials

Live Data​

The Rules Registry page shows real-time data from the CTWise regulatory rules engine, including:

  • Total rules by source and tier
  • Rule metadata including severity, therapeutic areas, and effective dates
  • Searchable catalog with keyword and source filtering

Update Frequency​

SourceUpdate FrequencyNotes
FDA General GuidanceDailyAutomated ingestion
ICH GuidelinesQuarterlyVersion-controlled
FDA OncologyMonthlySpecialized OCE guidance
EMA GuidanceMonthlyEU regulatory updates
WHO GuidelinesAnnualGlobal health standards

API Access​

Access the Rules Registry programmatically via the Search API:

Keyword Search (GET)​

curl "https://api.ctwise.ai/v1/rules?source=fda_oncology&query=oncology&limit=10" \
  -H "x-api-key: YOUR_API_KEY"

Semantic Search (POST)​

curl -X POST "https://api.ctwise.ai/v1/semantic-search" \
  -H "x-api-key: YOUR_API_KEY" \
  -H "Content-Type: application/json" \
  -d '{
    "query": "What are the FDA requirements for oncology clinical trials?",
    "sources": ["fda", "fda_oncology"],
    "limit": 10
  }'

Next: Browse the Rules Registry