What is CDASH?
CDASH is a standard for collecting clinical data.
The CDISC standard CDASH (Clinical Data Acquisition Standards Harmonization) provides a standard set of questions for creating CRFs (Case Report Forms) and a model to create new standard CRF questions.
CDISC CDASH Standards in an Organization
If CDASH is used by an organization it's CRFs become more consistent. It becomes easier for investigators and site staff to understand and enter data on the standard CDASH CRFs. This can contribute to improved data quality and timeliness.
It easier for teams (internal/external) to develop and review CDASH CRFs.
CDISC CDASH Standards for the Clinical Research Community
If CDASH is used across the entire clinical research community, sites will be entering data in CRFs designed to the same question format, layout and best practices. Reducing the variability between different organizations' CRFs.
SDTM Output by Design
CDASH variables map to SDTM by design.
Organizations that use CDASH reduce their SDTM mapping and dataset creation time. Compared to organizations that do not use an SDTM-like data collection standard this reduction can be significant.
Standard code and tools can be built upon CDASH output.
CDASH Documentation
CDASH aligns with SDTM, having a Model of core variables grouped by class, identifier and timing and an Implementation Guide that provides clinical topic domain CRF examples with use case assumptions and CRF build specifications.
CDASH has best practices, SDTM mapping and other data collection guidance.
Next Steps
ClinBuild also has introductions to the following CDISC standards:
Contact
If you require more information or CDASH consultancy services please contact on info@clinbuild.com or +49 176 578 16593.