For current versions of the Therapeutic Area (TA) standards, please visit the TA Home Page.
| Title Sort descending | Release Notes | Projected Publication Date |
|---|---|---|
| Alzheimer's Therapeutic Area User Guide v2.0.1 | Version 2.0.1 of the Alzheimer’s disease Therapeutic Area User Guide (TAUG-Alzheimer's) describes the most common biomedical concepts relevant to studies of Alzheimer’s disease and mild cognitive impairment, and the necessary metadata to represent such data consistently with Terminology and SDTM. TAUG-Alzheimer’s v2.0.1 updates the document to remove draft domains that were included in v2.0. The most recent version of the draft domains are available on the CDISC Wiki . TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints. Public Review Comments CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process. v2.0 of the Public Review comments represent the substantive comments for this release as well. |
|
| Alzheimer’s Therapeutic Area User Guide v2.0 | Version 2.0 of the Alzheimer’s Disease Therapeutic Area User Guide (TAUG-Alzheimer's) was developed under the CDISC Standards Development Process. TAUG-Alzheimer’s v2.0 describes the most common biomedical concepts relevant to studies of Alzheimer’s disease and mild cognitive impairment, and the necessary metadata to represent such data consistently with Terminology and SDTM. TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints. Public Review Comments CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.
|
|
| 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 |