CDASH

The Clinical Data Acquisition Standards Harmonization (CDASH) Standard version 1.1 is now available for download (see the links below).

CDASH Version 1.1 was developed via CDISC’s consensus-based standards development process that included comments from organizations in all three ICH regions (US, Europe and Japan). It describes the basic recommended (minimal) data collection fields for 18 domains, including common header fields, and demographic, adverse events, and other safety domains that are common to all therapeutic areas and phases of clinical research.  CDASH V 1.1also includes implementation recommendations and best practice guidelines, regulatory references and other information on the CDASH project.

The CDASH V 1.1 public review spreadsheet will be posted on the CDISC website soon.

Next Steps

In addition to working towards the publication of CDASH Version 1.1, the CDASH Team has been working on a number of related and supportive projects that include the development of a CDASH User Guide, CDASH-ODM metadata, and, in collaboration with the CDISC SDS and Terminology teams, the development of new domains and associated documents for medical devices and therapeutic area CRFs.  Following are short summaries about these important CDISC projects:

• CDASH User Guide

The CDASH Team and domain teams are currently reviewing comments from the public review of the CDASH User Guide (CDASH UG), which takes into account feedback received from early implementers and incorporates other additions and improvements that will make using the CDASH standard easier. The CDASH UG is targeted for publication in 2011 and will be available in the Members area of the CDISC website when published.

• CDASH-ODM

The CDASH-ODM team has developed the machine-readable metadata to accompany the CDASH standard and example CRFs created from their work are included in the CDASH UG and the updated CDASH training course. Both the ODM files (metadata) and the CDASH UG with conformant CRF examples will be available in the Members area of the CDISC website when published in 2011.

• CDISC Device Standard

The CDISC-AdvaMed Device team is working to develop both the basic collection fields (CDASH) and the submission (SDTM) variables and mappings to support the majority of device studies. The Device team is working towards producing an initial consensus version in late early 2011.

• CDISC Therapeutic Area CRFs

The CDASH  Team is working with other CDISC teams to develop therapeutic area (TA) specific CRFs to be used with the safety CRFs described in the CDASH standard.  Draft TA specific CRFs will be released for public review according to the CDISC consensus process.
 

Implementers of the CDASH standard are welcome to send feedback to Shannon Labout or Rhonda Facile.  Information on implementation experience will be used to continue to refine and improve the CDASH standard and other related standards.     

Contact

For more information on the CDASH project, and how to get involved, contact Shannon Labout or Rhonda Facile.