| Basic Data Structure for ADaM popPK Implementation Guide v1.0 |
|
| ADaM Conformance Rules v5.0 |
|
| CDASH Model v1.3 |
|
| CDASHIG v2.3 |
|
| COVID-19 Therapeutic Area User Guide v2.0 |
|
| CT-XML v1.2 (Controlled Terminology) |
|
| ODM v2.0 |
|
| Dataset-JSON v1.0 |
|
| TMF Reference Model v3.3.1 |
|
| SEND Conformance Rules v5.0 |
|
| SENDIG-DART v1.2 |
|
| SENDIG-Genetox v1.0 |
|
| Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0 |
|
| ADaM Metadata Submission Guidelines v1.0 |
|
| Pediatrics User Guide v1.0 |
|
| Glossary v17.0 |
|
| 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 |
|
| ADaM Conformance Rules v4.0 |
|
| ADaMIG for Medical Devices v1.0 |
|
| SDTM v2.0 |
|
| 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 |
|
| SDTMIG v3.4 |
|
| 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 |
|
| CDASHIG v2.1 |
|
| CDASH Model v1.1 |
|
| ADaMIG v1.2 |
|
| SENDIG-Animal Rule v1.0 |
|
| Nutrition Therapeutic Area User Guide v1.0 |
|
| SDTM v1.8 |
|
| 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 |
|
| Duchenne Muscular Dystrophy Therapeutic Area User Guide v1.0 |
|
| CDASHIG v2.0 |
|
| 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 |
|
| Pain Therapeutic Area User Guide v1.1 |
|
| Diabetic Kidney Disease Therapeutic Area User Guide v1.0 |
|
| 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 |
|
| SDTMIG v3.2 |
|
| SDTM v1.4 |
|
| Asthma Therapeutic Area User Guide v1.0 |
|
| 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 |
|