Rule SD1056

Pinnacle 21 Support SDTM
1

Hi Jean,

The two-character length was reserved for some cases as NA or ND. However according to SDTM IG only IE criteria violations should be submitted. Therefore you suggestion looks completely reasonable.

There are a lot of recent discussions around handling variable lengths. And users expectations are not well defined yet.

Regards,

Sergiy

2

The checking rule SD1056 was changed in version 1.4:

“The length of IE Criterion Result variables (IEORRES, IESTRESC) is expected to be 2”

But the vaules of IEORRES & IESTRESC should be only “Y”/“N”, does any reasons to modify the expected length to 2?