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
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.