Home / Standards / Standards in Development

Standards in Development

Foundational

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


Standard Development Public Review Release Notes
ADaM Conformance Rules v2.0
In Progress
Comments Due 12 Nov 2018
No

Public Review in Progress.

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

Resolving Public Comments.

ADaM Integration
Completed
No

Preparing for Public Review.

ADaM Medical Devices
Completed
No

Preparing for Public Review.

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
In Progress
Comments Due 30 Oct 2018
No

Public Review in Progress.

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

In Development.

SDTM v1.7
Completed
Completed

Preparing for Publication.

SDTMIG v3.3
Completed
Completed

Preparing for Publication.

SDTMIG v3.3 Conformance Rules
In Progress
No

In Development.

SDTMIG-Medical Devices v1.1
Completed
Completed

Preparing for Publication.

SDTMIG-PGx v1.1
In Progress
No

In Development.

SENDIG-Animal Rule v1.0
In Progress
No

In Development.

SENDIG-Dermal Ocular 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

 Resolving Public Comments.

ODM v2.0
In Progress
No

In Development.

RDF Reference Guide v1.1
Completed
Completed

Resolving Public Comments.

Therapeutic Areas

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


Therapeutic Area Development Public Review Release Notes
CDAD Therapeutic Area User Guide v1.0
Completed
Completed

Preparing for Publication.

Colorectal Cancer Therapeutic Area User Guide v1.0
Completed
Completed

Preparing for Publication.

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

In Development.

HIV Therapeutic Area User Guide v1.0
Completed
Completed

Resolving Public Comments.

Huntington's Disease Therapeutic Area User Guide v1.0
Completed
Completed

Resolving Public Comments.

Lung Cancer Therapeutic Area User Guide v1.0
Completed
No

Preparing for Public Review.

Nutrition Therapeutic Area User Guide v1.0
Completed
No

Preparing for Public Review.

PTSD Therapeutic Area User Guide v1.0
Completed
Completed

Resolving Public Comments.

Traditional Chinese Medicine - Coronary Artery Disease/Angina Therapeutic Area User Guide v1.0
Completed
Comments Due 30 Oct 2018
No

Public Review in Progress.