Standards in Development

Foundational

For current versions of the standards, please visit the Standards Home Page.


Standard Sort descending Release Notes Projected Publication
ADaM Oncology Examples

Resolving Public Comments.

2023
ADaM popPK Implementation Guide v1.0

Resolving Public Comments.

2023
Analysis Results Metadata (ARM) Conformance Rules

In Development.

2023
Analysis Results Standard v1.0

In Development.

2024
CDASH v1.3

Preparing for Public Review.

2023
CDASHIG v2.3

Preparing for Public Review.

2023
Safety User Guide v1.0

In Development.

2024
SDTM for Observational Studies v1.0

In Development.

2023
SDTM v2.1

In Development.

2023
SEND Tumor Combinations v1.0

Resolving Public Comments.

2023
SENDIG v4.0

In Development.

2023
SENDIG-DART v1.2

Resolving Public Comments.

2023
SENDIG-Genotoxicity v1.0

Resolving Public Comments.

2023
Tobacco Implementation Guide v1.0

In Development.

2023

Data Exchange

For current versions of the Data Exchange standards, please visit the Data Exchange Page.


Standard Sort descending Release Notes Projected Publication
ODM v2.0

Resolving Public Comments.

2023

Therapeutic Areas

For current versions of the Therapeutic Area (TA) standards, please visit the TA Home Page.


Therapeutic Area Sort descending Release Notes Projected Publication
COVID-19 Therapeutic Area User Guide v2.0

Preparing for Public Review.

2023
Rare Diseases Therapeutic Area User Guide

Public Review runs through 26 June.

2023