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.

Define-XML User Guide & Specs SDTM Implementation Guides ADaM Implementation Guides Controlled Terminology Metadata Submission Guidelines

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.

Mar 2025

PMDA Published Validation Rules Version 6.0

Jun 2024

Community 4.1.0 Released — Dataset-JSON Support

Rules

Validation Rules Update (FDA/PMDA)

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 GUIDES

Acute Kidney Injury Alzheimer's Asthma Breast Cancer By Disease Area Cardiovascular CDAD Colorectal Cancer COPD COVID-19 Crohn's Disease Diabetes Diabetes Type 1 - Exercise and Nutrition Diabetes Type 1 - Pediatrics and Devices Diabetes Type 1 - Screening, Staging and Monitoring of Pre-clinical Type 1 Diabetes Diabetic Kidney Disease Duchenne Muscular Dystrophy Dyslipidemia Ebola Heart Failure Hepatitis C Huntington's Disease Influenza Kidney Transplant Lung Cancer Major Depressive Disorder Malaria Multiple Sclerosis Nutrition Pain Pancreatic Cancer Parkinson's Disease Pediatrics Polycystic Kidney Disease Post Traumatic Stress Disorder Prostate Cancer Psoriasis Published User Guides QT Studies Rare Diseases Rheumatoid Arthritis Schizophrenia Traditional Chinese Medicine - Acupuncture Traditional Chinese Medicine - Coronary Artery Disease-Angina Traumatic Brain Injury Tuberculosis Vaccines Virology

FDA 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.

eCTD Resources

Official FDA

Data Standards Catalog

Official FDA

Study Data Technical Conformance Guide

Official FDA

(eCTD) - Providing Submissions in Electronic Format using the eCTD Specifications

Official FDA

(eCTD) - Submission Standards for eCTD v3.2.2 and Regional M1

Official FDA

(eCTD) - Submission Standards for eCTD v4.0 and Regional M1

Official FDA