Foundational

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


Standard Development Public Review Release Notes Projected Publication Date
ADaM Data Structures for Integration
Completed
Completed

Resolving Public Comments.

2020
ADaM Geriatric Depression Scale (GDS) Short Form Questionnaire Supplement
Completed
Completed

Resolving Public Comments.

2019
ADaM Medical Devices v1.0
Completed
No

Preparing for Public Review.

2020
ADaM OCCDS v1.1
In Progress
No

In Development.

2020
ADaM Oncology
In Progress
No

In Development.

2020
ADaM PK Analysis
In Progress
No

In Development.

ADaM Traceability Examples
In Progress
No

In Development.

2020
ADaMIG v1.2
Completed
Completed

Preparing for Publication.

2019
CDASH v2.1
Completed
Completed
2019
Conformance Rules v1.0 for SENDIG v3.0
Completed
No
Resolving Public Comments. 2019
Conformance Rules v1.0 for SENDIG v3.1
In Progress
No
2020
SDTM Metadata Submission Guidelines v2.0
In Progress
No
In Development. 2020
SDTM Variable Definitions
Completed
Comments Due 24 Sep 2019
No

Public Review runs through 24 Sep.

2019
SDTMIG v3.3 Conformance Rules
In Progress
No
In Development. 2020
SDTMIG v3.4
In Progress
No
In Development. 2020
SDTMIG-PGx v1.1
In Progress
No

In Development.

2020
SENDIG - Safety Pharmacology
In Progress
No
2019
SENDIG v3.1.1 PP, PC Updates
Completed
Completed
Resolving Public Comments. 2019
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
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
In Progress
No

In Development.

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

In Development.

2020
Diabetes - Type 1 Therapeutic Area User Guide v1.0
Completed
Comments Due 11 Nov 2019
No

Public Review Runs Through 11 Nov.

2020
Heart Failure Therapeutic Area User Guide v1.0
In Progress
No

In Development.

2020
Psoriasis Therapeutic Area User Guide v1.0
In Progress
No

In Development.

2020
Traditional Chinese Medicine - Acupuncture
In Progress
No

In Development.

2020