Checks related to length of variables

c Carol

on April 30, 2012

I don't think that checks related to lengths of variables should be included. FDA is pushing for reducing the length of each variable in a submission to the minumum length needed to accomodate the longest value. Therefore, for example, if the longest value of ARMCD in a submission is 4, the length should not be forced to 20.

Also, checks such as SD1054 which use the NY codelist should not be forced to a length of 1 for all the variables listed. "NA" is a valid value in the NY codelist. For example, if the collected value of CMOCCUR is "NA" for the birth control pill for males in the study, the length of this --OCCUR variable would need to be 2.

Forums: Validation Rule Suggestions

s Sergiy

on May 2, 2012

Hi! I agree with comment

Hi!

I agree with comment about checks around (NY) control terminology. They are already fixed, but not published yet.

Thank you,

Sergiy

m Michael

on June 11, 2012

What about ARMCD length?

I think Carol's comment about ARMCD length is also valid. We shouldn't see "warning" messages if we are using less than the recommended length of variables - the FDA seems to think that's a good thing!