AD0018 for STARTDTM

j Jenny

on March 17, 2017

Hi,

I got the warning "Variable label mismatch between dataset and ADaM standard" for variable STARTDTM in ADTTE. I checked both of ADTTE IG v1.0 and ADAM IG v1.1, the labels are different. The label in ADTTE IG is "Datetime of Time to Event Origin Date", the label in ADaM IG v1.1 is "Time-to-Event Origin Datetime". I thought that I should use the one in ADTTE IG, because the version of ADaMIG I used is v1.0. However, the pinnacle 21 enterprise complained by AD0018 warning. Could you let me know what is the right label for this variable for ADaM IG v1.0? Or Is this case a false positive warning?

Thanks,

Jenny

Forums: ADaM

s Sergiy

on March 17, 2017

"Time to Event Origin Date/Time"

Hi Jenny,

ADaM BDS for TTE Analysis v1.0 specifies STARTDTM Label as "Time to Event Origin Date/Time". We use this document as an extension for ADaM IG 1.0.

For some reasons you are missing "/Time" in your reference.

We do not support ADaM IG v1.1 because at this moment official validation rules from CDISC team is still not available.

Regards,

Sergiy

s Sergiy

on March 17, 2017

In P21E you can navigate to ....

In P21E you can navigate to "Home -> Manage Metadata -> Standards -> ADaM-IG 1.0 -> Variables" and use Filter/Search for particular variables to see expected CDISC labels.

j Jenny

on March 21, 2017

Hi Sergiy,…

Hi Sergiy,

Thank you for your response. I updated the label forSTARTDTM, it is fine now. However, for another variable AP01ETMF, I think the label on ADaM IG v1.0 is wrong, where the label is "Period End Time Imput. Flag" missing "xx". So we just followed ADaM IG v1.1 where the label has been corrected to "Period xx End Time Imput. Flag", even though it cause the metadata error from P21E.

Thanks,

Jenny