Clinical Data Standards Hub
Your central intelligence dashboard. Monitor CDISC standards, track FDA guidelines, and access community tools in real-time.
Ask questions on CDISC, FDA & ICH guidelines in natural language
Latest Blog Posts
Stay current with CDISC updates, FDA guidance, and community insights.
AI Code Generator
Generate SDTM/ADaM SAS code, debug programs, and explain standards with AI.
Submit an Article
Share your expertise and contribute to the clinical programming community.
Share a Project
Publish open-source tools and programs for the community to discover and use.
Get Certified
Earn a clinical programming certificate and showcase your standards knowledge.
Latest from the Blog
CDISC, FDA & community insights
Upcoming Conferences
Major events for clinical programmers
USDM & DDF
Unified Study Definitions Model: The future of protocol digitization and automation.
Explore USDMCDISC Open Source Alliance
CDISC Foundations
Core CDISC data standards that form the foundation of all clinical data submissions. These guides define the structure, variables, and metadata for SDTM, ADaM, and Define-XML — essential reading for every statistical programmer.
Pinnacle 21 Updates
Live updates from Pinnacle 21 — the industry-standard validation tool for CDISC datasets. Track new releases, rule updates, and Dataset-JSON support. Critical for pre-submission compliance checks.
Therapeutic Area User Guides (TAUGs) provide domain-specific CDISC data standards for individual diseases and conditions. Use the search below to find the TAUG relevant to your study's therapeutic area.
Therapeutic Area User Guides (TAUGs)
48 GUIDESFDA Resources
Live-scraped links from the FDA Study Data Standards Resources page. These include the Data Standards Catalog, eCTD conformance rules, validation specifications, and official guidance documents critical for US regulatory submissions.