Standards in Development

Foundational

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


Standard Release Notes Projected Publication
ADaM Geriatric Depression Scale (GDS) Short Form Questionnaire Supplement

Resolving Public Comments.

2020
ADaM Non-compartmental Analysis IG v1.0

Preparing for Public Review.

2021
ADaM OCCDS v1.1

Preparing for Publication.

2021
ADaM Oncology

In Development.

2021
ADaM Traceability Examples

In Development.

2021
ADaMIG Conformance Rules v3.0

Resolving Public Comments.

2020
ADaMIG Medical Devices v1.0

In Development.

2021
CDASH SAE Supplement v2.0

In Development.

2021
CDASH v1.2

In Development.

2021
CDASHIG v2.2

In Development.

2021
Conformance Rules v1.2 for SDTM v2.0 and SDTMIG v3.4

Resolving Public Comments for Batch 1.

Batch 2 is in Development.

2021
SDTM Metadata Submission Guidelines v2.0

Public Review runs through 20 Nov 2020.

2020
SDTM v2.0

Resolving Public Comments for Batch 1.

Batch 2 is in Development.

2021
SDTM Variable Definitions

Resolving Public Comments.

2020
SDTMIG v3.4

Resolving Public Comments for Batch 1.

Batch 2 is in Development.

2021
SEND Conformance Rules v2.0

Public Review.runs through 2 November.

2020
SENDIG v3.1.1 Preparing for Publication. 2021

Data Exchange

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


Standard Release Notes Projected Publication
Define-XML v2.1 Conformance Rules In Development. 2021
ODM v2.0

In Development.

2021

Therapeutic Areas

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


Therapeutic Area Release Notes Projected Publication
Crohn's Disease Therapeutic Area User Guide v1.0

Public Review for Work Package 1 runs through 28 Oct 2020.

Work Package 2 is being prepared for Public Review.

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

Public Review runs through 26 Oct 2020.

2020
Heart Failure Therapeutic Area User Guide v1.0

Preparing for Publication.

2020
Pancreatic Cancer Therapeutic Area User Guide v1.0

In Development.

2021
Traditional Chinese Medicine - Acupuncture

In Development.

2021