j junying


Dear P21,

When validating ADAM data package in P21E, we could specify the MEDDRA version. But in P21C, there is no place to specify MEDDRA version when validating ADAM data packages. Is there any reason why there is such different setting? Thank you very much. 

Forums: Enhancements and Feature Requests

on March 8, 2021

Hi Junying, 

In Enterprise there is no need to select MedDRA version for validation. It's already specified in your data package metadata. 

Kind Regards,

j junying
on March 9, 2021

P21E ADAM data package with MEDDRA option

Dear Sergiy,

do you mean it is not necessary to choose the MEDDRA option when we create the ADAMIG data package in P21E? The P21E data package has the option to choose the MEDDRA version. But for Pinnacle 21 Community, when I validate the ADAM .xpt files, there is no place to choose the MEDDRA version. The MEDDRA version is only available when we validate the SDTM .XPT datasets in Community. Thank you very much for your help.



on April 26, 2021

Hi Junying,

MedDRA validation is not used for analysis data in Community. Therefore, there is no need to specify MedDRA version.

Kind Regards,

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