ADaM

Hi Team,

Please suggest how to resolve AD0018: Variable label mismatch between dataset and ADaM standard for ADCM.ACAT01/02/03

Hello,

I get the following Error for the variable AVALU in ADNCA dataset: "AD0196: Required AVALU value is null".

The reason AVALU is null is because AVAL is missing.

From the ADaMIG for Non-compartmental Analysis Input Data V1.0, I understand that records with a missing AVAL can be included in the ADNCA dataset, is that correct?

If so, then should AVALU always be populated, even when AVAL is null?

Thank you,

Dana

Hello,

I get the following Error for the variables: ATOXDSCH and ATOXDSCL in both ADLB and ADVS datasets: "AD0018: Variable label mismatch between dataset and ADaM standard" (screenshot attached).

I checked and the labels matches the ADaMIG (V1.3).

Please advise if this is a known issue or if I have a mistake in my labels.

Thank you,

Dana

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