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Foundational

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


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

Resolving Public Comments.

ADaM Integration
Completed
Comments Due 21 May 2019
No

Public Review runs through 21 May.

ADaM OCCDS v1.1
In Progress
No

In Development.

ADaM Oncology
In Progress
No

In Development.

ADaM PK Analysis
In Progress
No

In Development.

ADaM Traceability Examples
In Progress
No

In Development.

ADaMIG v1.2
Completed
Completed

Preparing for Publication.

Analysis Results Metadata (ARM) Conformance Rules
In Progress
No

In Development.

CDASH v2.1
In Progress
No

In Development.

Confirmed Data Endpoints for Exchange (CoDEx) for SENDIG v3.1 Data
Completed
Completed

Preparing for Publication.

SDTM Metadata Submission Guidelines (MSG) v2.0
In Progress
No

In Development.

SDTM v1.8
Completed
Comments Due 29 Apr 2019
No

Public Review Runs Through 29 April

SDTM/CDASH Variable Definitions v1.0
In Progress
No
SDTMIG v3.3 Conformance Rules
In Progress
No

In Development.

SDTMIG-PGx v1.1
In Progress
No

In Development.

SEND Conformance Rules v1.0
In Progress
No

In Development.

SENDIG-Animal Rule v1.0
In Progress
Comments Due 29 Apr 2019
No
SENDIG-Dermal Ocular v1.0
In Progress
No

In Development.

SENDIG-Genotoxicity v1.0
In Progress
No

In Development.

Data Exchange

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


Standard Development Public Review Release Notes
Define-XML v2.1
Completed
Completed

 Preparing for Publication.

ODM v2.0
In Progress
No

In Development.

Therapeutic Areas

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


Therapeutic Area Development Public Review Release Notes
Acute Kidney Injury Therapeutic Area User Guide v1.0
In Progress
No

In Development.

CDAD Therapeutic Area User Guide v1.0
Completed
Completed

Preparing for Publication.

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

In Development.

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

In Development.

Diabetes - Type 1 Therapeutic Area User Guide v1.0
In Progress
No

In Development.

Lung Cancer Therapeutic Area User Guide v1.0
Completed
Completed

Resolving Public Comments.

Nutrition Therapeutic Area User Guide v1.0
Completed
Completed

Resolving Public Comments.

Psoriasis Therapeutic Area User Guide v1.0
In Progress
No

In Development.

Traditional Chinese Medicine - Acupuncture
In Progress
No

In Development.

Traditional Chinese Medicine - Coronary Artery Disease/Angina Therapeutic Area User Guide v1.0
Completed
Completed

Preparing for Publication.