AD0138: CRITy is populated and CRITyFL is not populated - this is not a rule

Posted Fri, 02/04/2011 - 10:57 by lehrkam

This check "When CRITy (Analysis Criterion) is populated, it's corresponding Analysis Criterion Y Flag must be populated" should be changed. Missing values are allowed if the result is missing and the Example 2 was used (see "CDISC ADaM Implementation Guide Version 1.0", page 77, Table 4.7.1.2). Please update this check.

Best regards,
Matthias

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lehrkam's picture

Check seems to be correct - ADaM rule should be changed

by lehrkam - 02/07/2011 - 04:45

I think about this ADaM rule and I think the rule should be changed. If a result is missing the CRITyFL must also be missing. Why CRITy should be filled when the result is MISSING?

I often use the Y/N flag instead of Y/null because when all results do not fulfilled the criteria I need the text in CRITy to create requested tables. But I don't need tables for MISSING values.

What you think about this ADaM rule?

Perhaps it will be nice if you can forward this to the ADaM team.

Best Regards,
Matthias

mdigian's picture

Hi Matthias, we will be

by mdigian - 02/10/2011 - 16:23

Hi Matthias, we will be submitting this and all feedback to the ADaM team.   BTW, do you have my original reply to your comment here regarding AD0138 in an email or something that you could send to me ? 

lehrkam's picture

no email

by lehrkam - 02/16/2011 - 04:56

hi mdigian, I don't know what you mean. You didn't send an email to me. I replied on my own question.

kind regards,

Matthias

mdigian's picture

Reply

by mdigian - 02/16/2011 - 12:32

No problem.  I realized last week I didn't respond.  I had formed this detailed response and i must have lost my connection or perhaps hit preview only, followed by a close of my browser.   here's what I intended to send

I agree that "Missing values are allowed if the result is missing" as in example 2 ADaM IG 1.0", page 77, Table 4.7.1.2.    However because these were published checks in the ADaM Validation 1.0 document, we implemented them as is.   We did try to supplement the Validations with info from the Standard and IG.   But as you correctly indicate here, we sometimes missed the contradictions between rules and IG. 

 

CRITy: text defining conditions needed to satisfy presence of the criterion (Systolic Pressure >160)

CRITyFL:  was CRITy met (Y or N). 

CRITyFL must be present on the dataset if variable CRITy is present

CRITyFL  can be set to “Y” or “N” or null.  In Example 2, CRIT1FL is set to null for Subject 1005 because the criterion is unevaluable due to missing input(s).

 

The ADaM team may come back and say that the AD0138 is necessary to actually alert the user to the possibility of these missing inputs in addition to the CRITyFL variable not being populated.   I'll update this post once I have their feedback