Publications

Standard/Therapeutic Area Version Published Date
Glossary v18.0
Rare Diseases Therapeutic Area User Guide
ADaM Conformance Rules v5.0
Basic Data Structure for ADaM popPK Implementation Guide v1.0
CDASHIG v2.3
CDASH Model v1.3
COVID-19 Therapeutic Area User Guide v2.0
Dataset-JSON v1.0
CT-XML v1.2 (Controlled Terminology)
ODM v2.0
TMF Reference Model v3.3.1
SENDIG-DART v1.2
SENDIG-Genetox v1.0
SEND Conformance Rules v5.0
Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0
ADaM Metadata Submission Guidelines v1.0
Pediatrics User Guide v1.0
ADaM Examples of Traceability v1.0
Exchange Mechanism 1.0.2
Diabetes Type 1 Therapeutic Area User Guide - Screening, Staging and Monitoring of Pre-clinical Type 1 Diabetes
SDTMIG v3.4
ADaMIG for Medical Devices v1.0
SDTM v2.0
ADaM Conformance Rules v4.0
ADaM Structure for Occurrence Data Implementation Guide v1.1
ADaMIG v1.3
SDTM and SDTMIG Conformance Rules v2.0
ADaMIG for Non-compartmental Analysis Input Data v1.0
Pancreatic Cancer Therapeutic Area User Guide v1.0
CDASH Model v1.2
CDASHIG v2.2
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
Conformance Rules for Define-XML v2.1
SENDIG v3.1.1
SDTM Metadata Submission Guidelines v2.0
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
SDTM v1.8
SENDIG-Animal Rule v1.0
Nutrition Therapeutic Area User Guide 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
SDTM v1.7
SDTMIG v3.3
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
Virology Therapeutic Area User Guide v2.1
Influenza Therapeutic Area User Guide v1.1
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
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
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
Dataset-XML v1.0
SDTMIG-AP v1.0
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
ADaM v2.1
XML Schema Validation for Define.xml White Paper
LAB v1.0.1