CDASH establishes a standard way to collect data consistently 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.
Version 1.1 of the CDASH Model provides a general framework for creating fields to collect information on CRFs and includes the model metadata, which shows the standard variables in the model. CDASH v1.1 provides root naming conventions for CDASHIG variables that are intended to facilitate mapping into SDTMIG variables.
Version 2.1 of the CDASH Implementation Guide provides information on the implementation of CDASH Model v1.1 and includes the CDASHIG Metadata Table, which details additional specifications for data collection variables within each domain. The normative content of the CDASHIG v2.1 and the informative content metadata table comprise the CDASHIG and must be referenced together. CDASHIG v2.1 is based on SDTMIG v3.2.
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.
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.
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.
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.