Foundational
For current versions of the standards, please visit the Standards Home Page.
| Standard | Release Notes | Projected Publication Sort descending |
|---|---|---|
| SDTM v2.0 | Resolving Public Comments. |
November Release 2021 |
| ADaMIG Non-compartmental Analysis v1.0 and Conformance Rules | Resolving Public Comments. |
November Release 2021 |
| Conformance Rules v2.0 for SDTM v2.0 and SDTMIG v3.4 | Resolving Public Comments. |
November Release 2021 |
| SDTMIG v3.4 | Resolving Public Comments.
|
November Release 2021 |
| CDASH v1.2 | November Release 2021 | |
| ADaMIG Medical Devices v1.0 and Conformance Rules | November Release 2021 | |
| CDASHIG v2.2 | November Release 2021 | |
| ADaMIG v1.3 and Conformance Rules | November Release 2021 | |
| ADaM OCCDS v1.1 and Conformance Rules | Resolving Public Comments. |
November Release 2021 |
| ADaM Geriatric Depression Scale (GDS) Short Form Questionnaire Supplement | Preparing for Publication. |
Q1 2021 |
| SENDIG v3.1.1 and Conformance Rules v3.0 | Preparing for Publication. | Q1 2021 |
| CDASH SAE Supplement v2.0 | Q2 2021 | |
| SDTM Metadata Submission Guidelines v2.0 | Resolving Public Comments. |
Q2 2021 |
| ADaM Oncology Examples | In Development. |
Q4 2021 |
| SEND Conformance Rules v4.0 | Preparing for Public Review. |
Q4 2021 |
| ADaM Traceability Examples | In Development. |
Q4 2021 |
| Medical Devices Conformance Rules | In Development. |
Q4 2021 |
Data Exchange
For current versions of the Data Exchange standards, please visit the Data Exchange Page.
| Standard | Release Notes | Projected Publication Sort descending |
|---|---|---|
| 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 | Release Notes | Projected Publication Sort descending |
|---|---|---|
| Diabetes Type 1 Therapeutic Area User Guide v1.0 - Exercise and Nutrition Modules | Resolving Public Comments. |
Q2 2021 |
| Crohn's Disease Therapeutic Area User Guide v1.0 | Resolving Public Comments for Work Packages 1 and 2.
|
Q2 2021 |
| 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 |
| Diabetes Type 1 Therapeutic Area User Guide - Prevention | Q2 2021 | |
| Diabetes Type 1 Pediatrics and Devices: ADaM Examples Module | Q2 2021 | |
| Traditional Chinese Medicine - Acupuncture Therapeutic Area User Guide v1.0 | Preparing for Public Review. |
Q3 2021 |
| Pancreatic Cancer Therapeutic Area User Guide v1.0 | Q3 2021 |