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

Preparing for Publication

Q3 2023
ADaM v3.0

In Development

2025
Analysis Results Metadata (ARM) Conformance Rules

In Development

2024
Analysis Results Standards v1.0

In Development

2024
CT Relationships for SDTM v1.7, SDTMIG v3.3, SDTMIG-MD v1.1

Public Review through 18 September

Q4 2023
Safety User Guide v1.0

In Development

2024
SDTM for Observational Studies v1.0

Public Review through 28 September

Q4 2023
SDTM v2.1

Resolving Internal Review Comments

Q4 2023
SDTM v2.2

In Development

2024
SDTMIG v4.0

In Development

2025
SEND Tumor Combinations v1.0

Preparing for Publication

Q3 2023
SENDIG v4.0

In Development

2024
Tobacco Implementation Guide v1.0

Resolving Internal Review Comments

Q4 2023

Therapeutic Areas

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