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
FDA 483 Inspection Intelligence
FDA inspection observations, classifications, and enforcement data:
- FDA 483 Observations -- Inspectional observations from Form 483s issued at facility inspections
- Inspection Classifications -- NAI/VAI/OAI outcomes for all FDA-inspected facilities
- Compliance Actions -- Warning Letters, Consent Decrees, and enforcement escalations
- Investigator Profiles -- FDA investigator inspection patterns and citation focus areas
| Source | Update Frequency | Coverage |
|---|---|---|
| FDA Data Dashboard API | Weekly (Mondays) | Inspections, citations, classifications |
| FDA Compliance Actions | Weekly | Warning Letters, Consent Decrees |
| FDA FOIA Reading Room | Monthly | Full observation text (PDF 483s) |
Learn more about 483 Intelligence →
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
| Source | Update Frequency | Notes |
|---|---|---|
| FDA General Guidance | Daily | Automated ingestion |
| ICH Guidelines | Quarterly | Version-controlled |
| FDA Oncology | Monthly | Specialized OCE guidance |
| EMA Guidance | Monthly | EU regulatory updates |
| WHO Guidelines | Annual | Global 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
}'