Standards in Development

Foundational

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


Standard Sort ascending Release Notes Projected Publication
Tobacco Implementation Guide v1.0

In Development.

2023
SENDIG-Genotoxicity v1.0

Public Review runs through 6 February.

2023
SENDIG-DART v1.2

Resolving Public Comments.

2023
SENDIG v4.0

In Development.

2023
SEND Tumor Combinations v1.0

Resolving Public Comments.

2023
SDTM v2.1

In Development.

2023
SDTM for Observational Studies v1.0

In Development.

2023
Safety User Guide v1.0

In Development.

2023
CDASHIG v2.3

In Development.

2023
CDASH v1.3

In Development.

2023
Analysis Results Standard v1.0

In Development.

2023
Analysis Results Metadata (ARM) Conformance Rules

In Development.

2023
ADaM popPK Implementation Guide v1.0

Resolving Public Comments.

2023
ADaM Oncology Examples

Resolving Public Comments.

2023
ADaM Metadata Submission Guidelines v1.0

Resolving Public Comments.

2023

Data Exchange

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


Standard Sort ascending 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 ascending Release Notes Projected Publication
Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0

Resolving Public Comments.

2023
Rare Diseases Therapeutic Area User Guide

In Development.

2023
Pediatrics User Guide v1.0

Preparing for Publication.

Q1 2023
COVID-19 Therapeutic Area User Guide v2.0

In Development.

2023