Standards in Development

Foundational

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


Standard Sort descending Release Notes Projected Publication
ADaM Geriatric Depression Scale (GDS) Short Form Questionnaire Supplement

Preparing for Publication.

Q1 2021
ADaM OCCDS v1.1 and Conformance Rules

Resolving Public Comments.

November Release 2021
ADaM Oncology Examples

In Development.

Q4 2021
ADaM Traceability Examples

In Development.

Q4 2021
ADaMIG Medical Devices v1.0 and Conformance Rules

Public Review runs through 2 Apr 2021.

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

Resolving Public Comments.

November Release 2021
ADaMIG v1.3 and Conformance Rules

Public Review runs through 16 Apr 2021.

November Release 2021
CDASH SAE Supplement v2.0

Resolving Public Comments.

Q2 2021
CDASH v1.2

Public Review runs through 22 Mar 2021.

November Release 2021
CDASHIG v2.2

Public Review runs through 22 Mar 2021.

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

Resolving Public Comments.

November Release 2021
Medical Devices Conformance Rules

In Development.

Q4 2021
SDTM Metadata Submission Guidelines v2.0

Resolving Public Comments.

Q2 2021
SDTM v2.0

Resolving Public Comments.

November Release 2021
SDTMIG v3.4

Resolving Public Comments.

 

November Release 2021
SEND Conformance Rules v4.0

Preparing for Public Review.

Q4 2021
SENDIG v3.1.1 and Conformance Rules v3.0 Preparing for Publication. Q1 2021

Data Exchange

For current versions of the Data Exchange standards, please visit the Data Exchange Page.


Standard Sort descending Release Notes Projected Publication
Conformance Rules v1.0 for Define-XML v2.1

Resolving Public Comments.

Q1 2021
ODM v2.0

In Development.

Q4 2021

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

Public Review runs through 2 Apr 2021.*

*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

Public Review runs through 11 Mar 2021.

Q2 2021
Diabetes Type 1 Therapeutic Area User Guide - Prevention

Preparing for Public Review.

Q2 2021
Diabetes Type 1 Therapeutic Area User Guide v1.0 - Exercise and Nutrition Modules

Resolving Public Comments.

Q2 2021
Pancreatic Cancer Therapeutic Area User Guide v1.0

Preparing for Public Review.

Q3 2021
Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0

Preparing for Public Review.

Q3 2021