CDASH – Clinical Data Acquisition Standards Harmonization

What is CDASH?

CDASH is a content standard for the data elements that should be captured on a Case Report Form (CRF).  It is exceedingly useful in establishing which data elements should be captured on common to all CRFs e.g. Adverse Events, Concomitant Medications, Labs, Inclusion/Exclusion Criteria etc.

Key Features:

• Clinical justification of why a variable should be gathered and its relationship to the submission (SDTM) dataset in which the captured data will finally appear
• CDASH content is  currently being represented within ODM metadata as CDASH ODM
• The CDASH content standard is extensible, i.e. additional variables can be gathered

Business Benefits of Using CDASH

Establishment of standardized CDASH libraries and CRFs will reduce study specification and design time through re-use and enable more effective communication between CROs and sponsors

CDASH aids mappings because it has an inherent link to the SDTM thus enabling companies to have standardized code and mappings to manipulate operational CDASH data into SDTM datasets. 

It is hoped that the standardised content of CDASH forms will simplify their completion at sites.

Mark Wheeldon, Formedix CEO, delivered a presentation on the practical uses of CDASH at a recent CDISC Interchange.  

Formedix Products which use the ODM to help you in your Clinical Trials Process:

• Origin^TM Study Modeller – Our dedicated CDISC ODM Study Database Design and Specification Tool can be used to create CDASH content in ODM