Publications

Standard/Therapeutic Area Version Published Date
COVID-19 Therapeutic Area User Guide v1.0
Crohn's Disease Therapeutic Area User Guide v1.0
Diabetes Type 1 Therapeutic Area User Guide v1.0 - Exercise and Nutrition Modules
Controlled Terminology Relationships v1.0 for SDTM v1.4 and SDTMIG v3.2
Diabetes Type 1 Therapeutic Area User Guide v2.0 - Pediatrics and Devices Modules
CDASH SAE Supplement v2.0
SENDIG v3.1.1
SEND Conformance Rules v3.0
SDTM Metadata Submission Guidelines v2.0
Conformance Rules for Define-XML v2.1
Glossary v15.0
ADaM Conformance Rules v3.0
Heart Failure Therapeutic Area User Guide v1.0
Psoriasis Therapeutic Area User Guide v1.0
Acute Kidney Injury Therapeutic Area User Guide v1.0
Conformance Rules v1.1 for SDTMIG v3.2 and v3.3
CDASH Model v1.1
CDASHIG v2.1
ADaMIG v1.2
ADaMIG v1.2 Release Package
Nutrition Therapeutic Area User Guide v1.0
SDTM v1.8
SENDIG-Animal Rule v1.0
BRIDG 5.3.1
Traditional Chinese Medicine - Coronary Artery Disease-Angina Therapeutic Area User Guide v1.0
Confirmed Data Endpoints for Exchange (CoDEx) for SENDIG v3.1 Data
Define-XML v2.1
Lung Cancer Therapeutic Area User Guide v1.0
CDAD Therapeutic Area User Guide v1.0
ADaM Conformance Rules 2.0
SDTMIG for Medical Devices v1.1
HIV Therapeutic Area User Guide v1.0
PTSD Therapeutic Area User Guide v1.0
SDTMIG v3.3
SDTM v1.7
Colorectal Cancer Therapeutic Area User Guide v1.0
Huntington's Disease Therapeutic Area User Guide v1.0
Vaccines Therapeutic Area User Guide v1.1
SENDIG - Developmental and Reproductive Toxicology (DART) v1.0
SENDIG-DART v1.1
SDTM v1.6
CDASHIG v2.0
Duchenne Muscular Dystrophy Therapeutic Area User Guide v1.0
CDASH Model v1.0
Confirmed Data Endpoints for Exchange (CoDEx) for SENDIG v3.0 Data
Influenza Therapeutic Area User Guide v1.1
Virology Therapeutic Area User Guide v2.1
Prostate Cancer Therapeutic Area User Guide v1.0
Schizophrenia Therapeutic Area User Guide v1.1
Malaria Therapeutic Area User Guide v1.0
Ebola Therapeutic Area User Guide v1.0
Diabetic Kidney Disease Therapeutic Area User Guide v1.0
Pain Therapeutic Area User Guide v1.1
Major Depressive Disorder Therapeutic Area User Guide v1.0
Rheumatoid Arthritis Therapeutic Area User Guide v1.0
Kidney Transplant Therapeutic Area User Guide v1.0
SDTM v1.5
SENDIG v3.1
Breast Cancer Therapeutic Area User Guide v1.0
CTR-XML v1.0
Tuberculosis Therapeutic Area User Guide v2.0
ADaMIG v1.1
ADaM Basic Data Structure (BDS) for Time-to-Event (TTE) Analyses v1.0
ADaMIG v1.1 Release Package
ADaM Structure for Occurrence Data (OCCDS) v1.0
COPD Therapeutic Area User Guide v1.0
Alzheimer's Therapeutic Area User Guide v2.0.1
Diabetes Therapeutic Area User Guide v1.0 - Supplement for ADaM
Traumatic Brain Injury Therapeutic Area User Guide v1.0
Dyslipidemia Therapeutic Area User Guide v1.0
CDISC Standards in RDF
SDTMIG-PGx v1.0 (Impending Deprecation)
Chronic Hepatitis C Therapeutic Area User Guide v1.0
Analysis Results Metadata (ARM) v1.0 for Define-XML v2.0
QT Studies Therapeutic Area User Guide v1.0
Cardiovascular Studies Therapeutic Area User Guide v1.0
Diabetes Therapeutic Area User Guide v1.0
Multiple Sclerosis Therapeutic Area User Guide v1.0
Define-XML v2.0
Dataset-XML v1.0
SDTMIG-AP v1.0
ODM-XML v1.3.2
SDTM v1.4
Asthma Therapeutic Area User Guide v1.0
SDTMIG v3.2
Polycystic Kidney Disease (PKD) Therapeutic Area User Guide v1.0
Parkinson’s Disease Therapeutic Area User Guide v1.0
Protocol Toolset v1.0
SDTMIG for Medical Devices v1.0
Metadata Submission Guideline (MSG) for SDTMIG
ADaM Examples in Commonly Used Statistical Analysis Methods
SENDIG v3.0
CDASH v1.1
Study Design in XML Version 1.0
PRM v1.0
ADaMIG v1.0 Release Package
ADaMIG v1.0
ADaM v2.1
XML Schema Validation for Define.xml White Paper
LAB v1.0.1