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CDASH Version 2.0 needs your input!


Please reply to this forum topic with your feedback and suggestions

The structure of CDASH standards v2.0 should be aligned with those of SDTM: 1) Add CDASH Model document: Provide a list of variables and definitions for different classes similar as that of SDTM. 2) CDASH Implementation Guide: Combine the materials from current CDASH standards and User Guide. Separate CDASH and SDTM variables name column and provide mapping and derivation. 3) Keep separate Example Library for CRF/eCRF form layout, CDASH annotations, ODM codes, etc.

The source of patients need to be collected which indicator the patients is hospital patients or outpatient.

I agree with Guang! Very important to see the relationships between CDASH and SDTM variables. Also, the new version needs to include most if not all of the domains in the most recent SDTMIG.

By the way, when is version 2.0 planned for?

We are keen to refer to upcoming CDASH v2.0, and post some comments below. 1) More and more SDTM domains are very rapidly added in the new version of SDTM IG or TAUG. Isn't it neccesary to import the lastest SDTM domains to CDASH quickly and correctly? We need your suggestions about the concept and process how to create domains that is not yet defined in CDASH. 2) It is useful to have the guide for the controlled terminology to be implemented in SDTM. 3) CDASH UG doesn't have the variable of coding dictionary version which could be included in SDTM or ADaM define.xml. We need your suggestions where to store it in CDASH. 4) We don't quite understand the variable EGPERF, why it is highly recommended. Would you show us some reasons or examples including the relationship between CDASH.EGPERF and SDTM.EGSTAT? 5) Could you release the CDASH "User Guide" for non-members? CDASH UG will accelerate the introduction of CDASH further.