Foundational

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


Standard Development Public Review Release Notes Projected Publication Date
ADaM Geriatric Depression Scale (GDS) Short Form Questionnaire Supplement
Completed
Completed

Resolving Public Comments.

2020
ADaM Non-compartmental Analysis IG v1.0
In Progress
No

In Development.

2021
ADaM OCCDS v1.1
Completed
Completed

Resolving Public Comments.

2021
ADaM Oncology
In Progress
No

In Development.

2021
ADaM Traceability Examples
In Progress
No

In Development.

2020
ADaMIG Medical Devices v1.0
In Progress
No

In Development.

2021
CDASH SAE Supplement v2.0
In Progress
No

In Development.

2021
Conformance Rules v1.0 for SENDIG v3.1
In Progress
No
2020
Conformance Rules v1.1 for SDTMIG v3.2 and v3.3
Completed
No

Resolving Public Comments.

2020
Conformance Rules v1.2 for SDTM v2.0 and SDTMIG v3.4
Completed
No

Preparing for Public Review.

2020
SDTM Metadata Submission Guidelines v2.0
In Progress
No
In Development. 2020
SDTM v2.0
Completed
No

Preparing for Public Review.

2020
SDTM Variable Definitions
Completed
Completed

Resolving Public Comments.

2020
SDTMIG v3.4
Completed
No

Preparing for Public Review.

2020
SENDIG v3.1.1 PP, PC Updates
Completed
Completed
Preparing for Publication. 2020
SENDIG-Genotoxicity v1.0
In Progress
No

In Development.

2020

Data Exchange

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


Standard Development Public Review Release Notes Projected Publication Date
Define-XML v2.1 Conformance Rules
In Progress
No
In Development. 2020
ODM v2.0
In Progress
No

In Development.

2020

Therapeutic Areas

For current versions of the Therapeutic Area (TA) standards, please visit the TA Home Page.


Therapeutic Area Development Public Review Release Notes Projected Publication Date
Acute Kidney Injury Therapeutic Area User Guide v1.0
Completed
Comments Due 24 Apr 2020
No

Public Review runs through 24 Apr.

2020
Crohn's Disease Therapeutic Area User Guide v1.0
In Progress
No

In Development.

2021
Diabetes - Type 1 Therapeutic Area User Guide v1.0
Completed
Completed

Resolving Public Comments.

2020
Heart Failure Therapeutic Area User Guide v1.0
Completed
Comments Due 8 May 2020
No

Public Review runs through 8 May.

2020
Pancreatic Cancer Therapeutic Area User Guide v1.0
In Progress
No

In Development.

2021
Psoriasis Therapeutic Area User Guide v1.0
Completed
Completed

Resolving Public Comments.

2020
Traditional Chinese Medicine - Acupuncture
In Progress
No

In Development.

2020