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Standards in Development

Foundational

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


Standard Development Public Review Release Notes
ADaM Compliance Checks
In Progress
No

In  Development.

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

Resolving Public Comments.

ADaM Integration
In Progress
No

In Development.

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) Validation Rules
In Progress
No

In Development.

CDASH v2.1
In Progress
No

In Development.

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
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
No

The standard is currently going through a second internal review. In the course of resolving comments received during the public review, changes to the standard were made, which will warrant a second public review.

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
Asthma Therapeutic Area User Guide v1.1
Completed
Completed

Preparing for Publication.

CDAD Therapeutic Area User Guide v1.0
Completed
Completed

Resolving public comments.

Colorectal Cancer
Completed
Completed

Preparing for Publication.

COPD Therapeutic Area User Guide v1.1
Completed
No

Preparing for Public Review.

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

In Development.

Diabetes Therapeutic Area User Guide v1.1
Completed
No

Preparing for Public Review.

Hepatitis C Therapeutic Area User Guide v1.1
Completed
No

Preparing for Public Review.

HIV Therapeutic Area User Guide v1.0
Completed
Comments Due 31 Jul 2018
No

Provide comments.

Huntington's Disease Therapeutic Area User Guide v1.0
Completed
Comments Due 31 Jul 2018
No

The Huntington Disease Standards Development Team has added an example to version 1.0 of the Huntington Disease Therapeutic Area User Guide, currently under development. This example is now undergoing a public review; we invite you to provide comments.

 

Lung Cancer Therapeutic Area User Guide v1.0
Completed
No

Preparing for Public Review.

Multiple Sclerosis Therapeutic Area User Guide v1.1
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.

QT Studies Therapeutic Area User Guide v1.1
Completed
No

Preparing for Public Review.

Traditional Chinese Medicine - Coronary Disease/Angina Therapeutic Area User Guide v1.0
Completed
No

Preparing for Public Review.

Traumatic Brain Injury Therapeutic Area User Guide v1.1
Completed
No

Preparing for Public Review.