ADaM

AD0047 issue being triggered for ADEX by FDA 2304.3 Engine.  This issue is unexpected because ADEX belongs in OTHER class.  

When I used FDA 2304.3 ADaMIG1.3，it reported AD0047 for ADCM. It seems --TERM isn't necessary for ADCM (only required for the SubClass ADVERSE EVENT domain). I'd appreciate it if this matter could be rectified. Thank you!

According to FDA standards catalog the requirement for ADaMIGv1.3 starts on 15March2024. Do you already know when this Data Standard can be validated by Pinnacle Community?

I'm getting this error message for numeric variables now. Do we need to fix the numeric variable length in ADaM now? Thanks

The USUBJID in BDS is actually the same as ADSL.USUBJID. However, the STUDYID of some records in BDS is different from ADSL.STUDYID because these records in BDS come from an extension study of the parent study. This is an integrated analysis of safety which includes the parent study and the extension study. USUBJID in both studies are the same and the STUDYID values of the 2 studies are different.

Hi Team,

I am getting AD0221 error for CHGCAT1 as value inconsistent with CHG values.

getting  error for record 

Record   PARAMCD   CHG                       CHGCAT1

Hi Team,

I am using the P21 community version P2120210.1 and ADaM IG 1.1 

I am getting AD0018 error for the below variable labels.

Hi Team,

We are getting AD0018 : variable label mismatch between dataset and ADaM standard for AENDTM and ASTDTM.

The labels are defined as below currently.

VARIABLE       LABEL

AENDTM  : Analysis End Datetime

Is there a way to have AD0221 not fire on the variable ACAT1? We have a purpose for this variable in a BDS structure and the variable is not categorizing an AVAL like the other CAT variables. The rule for AD0221 says: Within a study, All *CATy values must be the same for each unique value of the variable it categorizes within a PARAMCD. [AVAL:AVALCATy], [AVALC:AVALCATy], [BASE:BASECATy], [BASEC:BASECATy], [CHG:CHGCATy], [PCHG:PCHGCATy].  A category may be the same across values.

Hi All,

I have a question about ADaM generation.

An attempt was made to create an ADaM using only SDTM. However, SDTM was generated without some derived variable and ADaM programming team requested the variable without any changes to the SDTM.

So, unfortunately,  we created another DB containing the derived variable. The format of DB is not SDTM.

In the end, ADaM will be generated using SDTM and seperated DB (including derived variable).