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 | 2024 | |
| CT Relationships for SDTM v1.7, SDTMIG v3.3, SDTMIG-MD v1.1 | Q4 2023 | |
| Safety User Guide v1.0 | 2024 | |
| SDTM for Observational Studies v1.0 | 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.
| Therapeutic Area Sort descending | Release Notes | Projected Publication |
|---|---|---|
| Rare Diseases Therapeutic Area User Guide | Resolving Public Review Comments |
Q3 2023 |