Foundational
For current versions of the standards, please visit the Standards Home Page.
| Standard | Release Notes | Projected Publication Sort descending |
|---|---|---|
| ADaM Oncology Examples | Resolving Public Comments. |
2022 |
| Analysis Results Standard v1.0 | 2023 | |
| Safety User Guide v1.0 | 2023 | |
| Tobacco Implementation Guide v1.0 | 2023 | |
| SDTMIG-Medical Devices v2.0 and Conformance Rules | In Development. |
2023 |
| SENDIG v3.2 | In Development. |
2023 |
| SDTM v2.1 | In Development. |
2023 |
| SENDIG-Genotoxicity v1.0 | In Development. |
2023 |
| SENDIG-Dermal Ocular v1.0 | In Development. |
2023 |
| Conformance Rules for SDTMIG-Medical Devices v1.1 | Q4 2022 | |
| ADaM popPK Implementation Guide v1.0 | Q4 2022 |
Data Exchange
For current versions of the Data Exchange standards, please visit the Data Exchange Page.
| Standard | Release Notes | Projected Publication Sort descending |
|---|---|---|
| ODM v2.0 | 2022 |
Therapeutic Areas
For current versions of the Therapeutic Area (TA) standards, please visit the TA Home Page.
| Therapeutic Area | Release Notes | Projected Publication Sort descending |
|---|---|---|
| COVID-19 Therapeutic Area User Guide v2.0 | 2023 | |
| Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0 | Preparing for Public Review. |
Q4 2022 |
| Rare Diseases Therapeutic Area User Guide | Q4 2022 | |
| Pediatrics User Guide v1.0 | Q4 2022 |