ADaM vs. Define validation

Pinnacle 21 Support ADaM
1

Hi Dirk,

The general concept of OpenCDISC ADaM checks are different compare to all other validation profiles (e.g., SDTM, SEND). Currently OpenCDISC ADaM checks are limited to the CDISC ADaM Validation Checks 1.1 document (see it in CDISC Members-Only Area: http://www.cdisc.org/adam-validation ). Those checks are created based on direct citation of the ADaM IG. There is no text about a define.xml in the ADaM IG. Therefore no official CDISC ADaM validation checks related to define.xml were created.

I believe that pure ADaM Implementation Guide text compliance is not enough for real practical validation and we need some other data quality checks. Consistency between data and define file is a good example.

Best Regards,

Sergiy Sirichenko

2

Thanks for making that clear Sergiy. This is what I reckoned but needed someone to confirm.

3

Hi,

I was looking to find what checks are performed additionally when I provide a define file to OpenCDISC whenever I am validating the ADaM datasets with ADaM configuration. I did not find any answer (or I looked in all the wrong places).

Can anyone help me out on this one?

I have a general interest: all checks on define vs. data.
And I have a particular interest: Is CT -as provided in the define - checked against the data in the ADs (analysis datasets)?

Thanks!