v Venkata
on

 

Hi -

We have AEDECOD in upper case but MedDRA ascii files are in first letter in upper latter and remaining in lower case - so i can see a warning message (SD0008C) while running Open CDISC check - Do I need to modify DECOD element?

Thanks a lot for your help.

Venkata

 

Forums: SDTM

s Sergiy
on August 1, 2013

Hi Venkata, 

To be compliant with the MedDRA standard you need to populate AEDECOD values as specified in the MedDRA dictionary.

Kind Regards, 

Sergiy

v Venkata
on August 2, 2013

Thanks a lot Sergiy, I agree its better to change the case to eliminate the warning messages from AE and MH domain.

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