CDASH establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review. 


CDASH 2.0

2.0
Release Date: 25 Sep 2017

CDASH 2.0 comprises the CDASHIG v2.0, the CDASH Model v1.0, and CDASHIG metadata tables to define basic standards for the collection of clinical trial data and how to implement the standard for specific case report forms. 

CDASHIG v2.0 and CDASH Model v1.0 metadata are available in the CDISC Library Archives section of the CDISC Members Only Area of our web site. If you are an employee of a CDISC Member Organization, you can access this metadata by logging into your account and visiting the Members Only Area in the upper right-hand corner of the web site.

HTML Format

CDASH v2.0 is published in HTML format, which expedites delivery of the standard and is viewable in any standard browser. HTML format allows users to search for keywords within the page, and bookmark the information in a browser. Implementers can also print the page, or export the information into other formats (e.g., PDF). To save a copy of the HTML publication on your desktop to access the document offline, press CTRL-S (PC) or COMMAND-S (Mac) on your keyboard.

Please log in or create an account to access the links to the Standard.


CDASH Serious Adverse Event (SAE) Supplement v1.0

1.0
Release Date: 22 Nov 2013

This supplement expands the AE domain in CDASH to include additional data elements to capture information in an SAE form, facilitating Sponsor generation of an E2B message for electronic reporting of an Individual Case Safety Report (ICSR) to regulatory authorities.