Standards in Development

Foundational

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


Standard Sort descending Release Notes Projected Publication
ADaM Examples of Traceability

Resolving Public Comments.

Q4 2021
ADaM OCCDS v1.1 and Conformance Rules

Preparing for Publication.

Q4 2021
ADaM Oncology Examples

In Development.

2022
ADaMIG Medical Devices v1.0 and Conformance Rules

Preparing for Publication.

Q4 2021
ADaMIG Non-compartmental Analysis v1.0 and Conformance Rules

Preparing for Publication.

Q4 2021
ADaMIG v1.3 and Conformance Rules

Preparing for Publication.

Q4 2021
Analysis Results Standard v1.0

In Development.

2022
Conformance Rules v2.0 for SDTM v2.0 and SDTMIG v3.4

Preparing for Publication.

Q4 2021
Medical Devices Conformance Rules

In Development.

2022
Safety User Guide v1.0

In Development.

2022
SDTM v2.0

Preparing for Publication.

Q4 2021
SDTMIG v3.4

Preparing for Publication.

 

Q4 2021

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

In Development.

2022

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

Resolving Public Comments.

Q4 2021
Pediatrics User Guide v1.0

In Development.

2022
Rare Diseases Therapeutic Area User Guide

In Development.

Q1 2022
Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0

Preparing for Public Review.

2022