ADaM

Since FDA 2304.3 engine was introduced last month, I have started getting a lot of SD1082 issue (Variable length is too long for actual data), while I did not get them with the previous engine (2204.1) when running ADaM validation check. I like to confirm if it is an expected behavior. The variables flagged with SD1082 issues are the standard ADaM variables such as AVALC, SHIFTx, CRITx, PARAM, AVISIT, BASETYPE, PARCATx. Below is an example:

Hi, 

I get the following error: Variable label mismatch between dataset and ADaM standard for COHORT, NCAXFL and NRRLT variables in my ADNCA dataset.

I have used the labels provided in the "Analysis Data Model Implementation Guide for Non-compartmental Analysis Input Data" document, but I keep receiving an error.

Am I possibly making a mistake in implementing the labels? I would appreciate any guidance you can provide or if we could further discuss the issue.

Letizia

When using the FDA 2304.3 engine, the AD0047 issue is being triggered for ADMH, even though MHTERM variable exists in the dataset.

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.