Foundational
For current versions of the standards, please visit the Standards Home Page.
Standard Sort descending | Release Notes | Projected Publication |
---|---|---|
ADaM Geriatric Depression Scale (GDS) Short Form Questionnaire Supplement | Preparing for Publication. |
Q1 2021 |
ADaM OCCDS v1.1 and Conformance Rules | Resolving Public Comments. |
November Release 2021 |
ADaM Oncology Examples | In Development. |
Q4 2021 |
ADaM Traceability Examples | In Development. |
Q4 2021 |
ADaMIG Medical Devices v1.0 and Conformance Rules | November Release 2021 | |
ADaMIG Non-compartmental Analysis v1.0 and Conformance Rules | Resolving Public Comments. |
November Release 2021 |
ADaMIG v1.3 and Conformance Rules | November Release 2021 | |
CDASH SAE Supplement v2.0 | Q2 2021 | |
CDASH v1.2 | November Release 2021 | |
CDASHIG v2.2 | November Release 2021 | |
Conformance Rules v2.0 for SDTM v2.0 and SDTMIG v3.4 | Resolving Public Comments. |
November Release 2021 |
Medical Devices Conformance Rules | In Development. |
Q4 2021 |
SDTM Metadata Submission Guidelines v2.0 | Resolving Public Comments. |
Q2 2021 |
SDTM v2.0 | Resolving Public Comments. |
November Release 2021 |
SDTMIG v3.4 | Resolving Public Comments.
|
November Release 2021 |
SEND Conformance Rules v4.0 | Preparing for Public Review. |
Q4 2021 |
SENDIG v3.1.1 and Conformance Rules v3.0 | Preparing for Publication. | Q1 2021 |
Data Exchange
For current versions of the Data Exchange standards, please visit the Data Exchange Page.
Standard Sort descending | Release Notes | Projected Publication |
---|---|---|
Conformance Rules v1.0 for Define-XML v2.1 | Resolving Public Comments. |
Q1 2021 |
ODM v2.0 | In Development. |
Q4 2021 |
Therapeutic Areas
For current versions of the Therapeutic Area (TA) standards, please visit the TA Home Page.
Therapeutic Area Sort descending | Release Notes | Projected Publication |
---|---|---|
COVID-19 Therapeutic Area User Guide v1.0 | Public Review runs through 2 Apr 2021.* *CDISC expedited our standards development process to release an Interim User Guide for COVID-19 in early April 2020. We are now developing a Therapeutic Area User Guide for COVID-19 following our standards development process outlined in COP-001. |
Q2 2021 |
Crohn's Disease Therapeutic Area User Guide v1.0 | Resolving Public Comments for Work Packages 1 and 2.
|
Q2 2021 |
Diabetes Type 1 Pediatrics and Devices: ADaM Examples Module | Q2 2021 | |
Diabetes Type 1 Therapeutic Area User Guide - Prevention | Q2 2021 | |
Diabetes Type 1 Therapeutic Area User Guide v1.0 - Exercise and Nutrition Modules | Resolving Public Comments. |
Q2 2021 |
Pancreatic Cancer Therapeutic Area User Guide v1.0 | Q3 2021 | |
Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0 | Preparing for Public Review. |
Q3 2021 |