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.

2022
ADaM popPK Implementation Guide v1.0

In Development.

Q4 2022
Analysis Results Standard v1.0

In Development.

2023
Conformance Rules for SDTMIG-Medical Devices v1.1

In Development.

Q4 2022
Safety User Guide v1.0

In Development.

2023
SDTM v2.1

In Development.

2023
SDTMIG-Medical Devices v2.0 and Conformance Rules

In Development.

2023
SENDIG v3.2

In Development.

2023
SENDIG-Dermal Ocular v1.0

In Development.

2023
SENDIG-Genotoxicity v1.0

In Development.

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.


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

In Development.

2023
Pediatrics User Guide v1.0

Public Review runs through 25 August.

Q4 2022
Rare Diseases Therapeutic Area User Guide

In Development.

Q4 2022
Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0

Preparing for Public Review.

Q4 2022