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TRTAG1 in BDS datasets
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Michael
on March 24, 2011
TRTAG1 expected
Hi Natalie. You're right.
- the IG does mention exactly when this variable is required.
- The config-adam-1.0.xml however lists it as Expected.
- Feel free to change the Core property to Conditionally Required.
- 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.
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