Standards in Development

Foundational

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


Standard Sort descending Release Notes Projected Publication
ADaM OCCDS v1.1 and Conformance Rules

Resolving Public Comments.

Q4 2021
ADaM Oncology Examples

In Development.

2022
ADaM Traceability Examples

In Development.

Q4 2021
ADaMIG Medical Devices v1.0 and Conformance Rules

Resolving Public Comments.

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

Resolving Public Comments.

Q4 2021
ADaMIG v1.3 and Conformance Rules

Public Review runs through 16 Apr 2021.

Q4 2021
CDASH SAE Supplement v2.0

Preparing for Publication.

Q2 2021
CDASH v1.2

Resolving Public Comments.

Q3 2021
CDASHIG v2.2

Resolving Public Comments.

Q3 2021
Conformance Rules v2.0 for SDTM v2.0 and SDTMIG v3.4

Resolving Public Comments.

Q4 2021
Medical Devices Conformance Rules

In Development.

2022
SDTM v2.0

Resolving Public Comments.

Q4 2021
SDTMIG v3.4

Resolving Public Comments.

 

Q4 2021
SEND Conformance Rules v4.0

Preparing for Public Review.

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
COVID-19 Therapeutic Area User Guide v1.0

Resolving Public Comments.*

*CDISC expedited our standards development process to release an Interim User Guide for COVID-19 in early April 2020. We are now developing a Therapeutic Area User Guide for COVID-19 following our standards development process outlined in COP-001.

Q2 2021
Crohn's Disease Therapeutic Area User Guide v1.0

Resolving Public Comments for Work Packages 1 and 2.

 

Q2 2021
Diabetes Type 1 Pediatrics and Devices: ADaM Examples Module

Resolving Public Comments.

Q2 2021
Diabetes Type 1 Therapeutic Area User Guide - Prevention

Preparing for Public Review.

Q3 2021
Diabetes Type 1 Therapeutic Area User Guide v1.0 - Exercise and Nutrition Modules

Preparing for Publication.

Q2 2021
Pancreatic Cancer Therapeutic Area User Guide v1.0

Public Review runs through 10 May.

Q3 2021
Rare Diseases Therapeutic Area User Guide

In Development.

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

Preparing for Public Review.

Q4 2021