The Clinical Data Acquisition Standards Harmonization (CDASH) Standard version 1.0 is now openly available for download from the CDISC website. You may also access the CDASH Public Review Spreadsheet to see the comments that were received during the review period prior to the release of CDASH version 1.0.
The published, consolidated CDASH Standard Version 1.0 document represents a global, consensus-based standards development process with comments from organizations in all of the ICH regions (US, Europe and Japan). It describes the basic recommended (minimal) data collection fields for 16 domains, including demographic, adverse events, and other safety domains that are common to all therapeutic areas and types of clinical research. The document also includes implementation recommendations and best practice guidelines, regulatory references and other information on the CDASH project. It is posted openly in the Standards area on the CDISC website.
Next Steps
Since the publication of the CDASH Version 1.0 in October of 2008, the CDASH Core Team has been working to develop a CDASH User Guide (CDASHUG) the CDASH-ODM team has been developing the machine readable metadata (CDASH-ODM) for all the CDASH domains and the CDISC-AdvaMed Device team is drafting the basic data collection fields and submission variables for device studies. Following are short summaries about their activities:
- The CDASH Core Team and domain teams are working on CDASH v 1.1 which will take into account feedback received to date from early implementers as well incorporating other additions and enhancements to make the standard even more useful. Targeted for publication in Q110.
- The CDASH-ODM team is working on developing the machine readable metadata to accompany the CDASH standard by providing style sheets in the CDASHUG. We plan to publish both the ODM files (metadata) and the standardized CDASH compliant CRF screenshots/style sheets.
- The CDASH Core Team and domain teams are working on a new CDASH User Guide (CDASHUG) will provide users with more detailed and specific implementation instruction, incorporate CRF samples with and without annotation generated from the CDASH-ODM work as well as guidance around data structures and mapping to the SDTM. Targeted for publication in Q110.
- The CDISC-AdvaMed Device team is working to develop both the basic collection fields (CDASH) and the submission (SDTM) variables and mapping to support the majority of device trials. We expect to have the initial consensus version from this team towards the end of 2009 and the final published standard in Q210.
All implementers of the CDASH standard are encouraged to send feedback to Rhonda Facile or Shannon labout. Implementation information gathered will be used to further refine and improve the CDASH standard and other related standards.
Contact
For more information on CDASH, and how to get involved, contact Rhonda Facile or Shannon labout
