Standards in Development

Foundational

For current versions of the standards, please visit the Standards Home Page.


Standard Sort ascending Release Notes Projected Publication
Safety User Guide v1.0

In Development.

2022
Medical Devices Conformance Rules

In Development.

2022
Analysis Results Standard v1.0

In Development.

2022
ADaM Oncology Examples

In Development.

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 Sort ascending Release Notes Projected Publication
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 Sort ascending Release Notes Projected Publication
Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0

Preparing for Public Review.

2022
Rare Diseases Therapeutic Area User Guide

In Development.

Q1 2022
Pediatrics User Guide v1.0

In Development.

2022
Diabetes Type 1 Therapeutic Area User Guide - Screening, Staging and Monitoring of Pre-clinical Type 1 Diabetes

Preparing for Publication

Q4 2021