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 | 2023 | |
| Analysis Results Metadata (ARM) Conformance Rules | In Development. |
2023 |
| Analysis Results Standard v1.0 | 2024 | |
| CDASH v1.3 | Preparing for Public Review. |
2023 |
| CDASHIG v2.3 | Preparing for Public Review. |
2023 |
| Safety User Guide v1.0 | 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 | 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 | 2023 | |
| Rare Diseases Therapeutic Area User Guide | 2023 |