Non-ASCII characters in ADaM datasets

Pinnacle 21 Support ADaM
1

Hi Ciani,

There is a difference in validation rules between ADaM and SDTM.

ADaM validation checks are limited to Standard Compliance, while SDTM checks include additional Regulatory Review-specific rules and Data Quality checks.

Today CDISC ADaM team is the only publisher of ADaM validation rules.

“Non-ASCII character” check is an example of FDA/PMDA validation rules for SDTM data. FDA does not have any ADaM-specific validation rules.

Regards,

Sergiy

2

Hi,

I noticed there were no P21 issues for non-ascii characters in ADaM datasets. Do you know if non-ascii characters are allowed for ADaM? There are issues that appear in P21 if non-ascii chars are present in SDTM datasets. I am wondering why none are added for ADaM.

Thanks.