Confusing… [Software]

posted by Helmut Homepage – Vienna, Austria, 2019-03-25 13:44  – Posting: # 20083
Views: 1,476

Hi Dr Anonymous,

» Well that is true as to what FDA states and is applicable in the SDTM datasets, However in Adam datasets, especially ADSL datasets under certain variables such as treatment start and end, it requires SAS date format, only then we get a successful validation report from Pinnacle 21 (I have tried ISO 8601 and have got validation errors stating "variable is not in sas date format")

Now I’m lost. The FDA and Japan’s PMDA are the only agencies requiring CDISC Standards. Both are “Platinum Members” (whatever that means) of CDISC Standards. So far, so good.
But why the heck is CDISC requiring the bloody SAS date format for SDTM and SEND when the FDA definitely wants ISO 8601? At the end of the day you will submit your data to an agency and not a validator.

I bit the bullet and registered at CDISC. :lookaround:
In the “ADaM Implementation Guide” Version 1.1 (Feb 12th, 2016), page 17 I found:

SDTM--DTC String  ADaM Date Value (*DT Variable)
    YYYY-MM-DD            YYYY-MM-DD


So how does the SAS-format come into play? PINNACLE21 was released on Sep 27th, 2016. Is the validator not compliant with the standards?

Cheers,
Helmut Schütz
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