Foundational
For current versions of the standards, please visit the Standards Home Page.
| Standard | Release Notes | Projected Publication Sort descending |
|---|---|---|
| ADaM Oncology Examples | In Development. |
2022 |
| Medical Devices Conformance Rules | In Development. |
2022 |
| Analysis Results Standard v1.0 | 2022 | |
| Safety User Guide v1.0 | 2022 | |
| ADaM Examples of Traceability | Resolving Public Comments. |
Q1 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 | In Development. |
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 |
|---|---|---|
| Pediatrics User Guide v1.0 | 2022 | |
| Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0 | Preparing for Public Review. |
2022 |
| Rare Diseases Therapeutic Area User Guide | Q1 2022 | |
| Diabetes Type 1 Therapeutic Area User Guide - Screening, Staging and Monitoring of Pre-clinical Type 1 Diabetes | Preparing for Publication |
Q4 2021 |