TRTAG1 in BDS datasets

Posted Thu, 03/24/2011 - 04:33 by nsteigerwald

HI,

I have a question. During the check it comes out that the variable TRTAG1 should be presented (e.g. ADLB). It is not clear to me, why this variable should be available. It is a parallel arm design and in ADLB following treatment variables are available: TRTA, TRTP. According to the guideline:

Actual pooled treatment y. "y" represents an integer [1-9] corresponding to a particular pooling scheme. Required when TRTPGy is present and TRTA is present. May vary by record within a subject.

 

  In my dataset TRTPGy is not presented.

Regards,

Natalie

 

‹ RuleID skip_AD0053 AD1008: Null value in variable marked as Required ›
mdigian's picture

TRTAG1 expected

by mdigian - 03/24/2011 - 16:09

Hi Natalie.  You're right.

  1. the IG does mention exactly when this variable is required.
  2. The config-adam-1.0.xml however lists it as Expected.
  3. Feel free to change the Core property to Conditionally Required.  
  4. This will cease the AD1002 WARNING message

<ItemRef ItemOID="TRTAG1" OrderNumber="11" Mandatory="No" Role="Treatment" val:Core="Expected"/>

There currently is no rule in the ADaM Validation Checks v1.1 to cover this.  Do you think there should be ?

Finally, for future posts, include the Rule/Validation in error (e.g. AD1002).  It will ensure the fastest and most accurate response.

Thanks for your support.

Mike D.