ADaM

Hi Team,

I'm getting "AD0018: Variable label mismatch between dataset and ADaM standard" issue for "ASEQ" variables in multiple domains, for example ADCM, even though the labels actually match ADaM V1.1 standard. We are using P21 Enterprise engine 2405.1.

The errors were not appearing in earlier version.

Could you please look into this?

Thanks,

Peng

We need to submit ISS for NDA. When we reviewed the ADaMs for ISS, we found out that IADSL has multiple record per subject and IADAE has multiple records for the same AE event on the same date for the subject. We have the following questions for you:

For ISS ADSL:

      Will FDA accept or reject when we name it as IADSL instead of ADSL?

Hi, I'm getting "Required variable is not present" issue for "--SEQ" variables in multiple domains, for example ADCM, even though they are present in the datasets.

The errors were not appearing in engine 2304.3.

Could you please look into this?

In my TTE dataset, I have STARTDTM, but not STARTDT. ADaM IG 1.3 lists both STARTDT and STARTDTM as permissible, so it should be fine to have STARTDTM only, and not include STARTDT, but I am still receiving the message. I'm using Engine FDA 2304.3.

Thanks,

Elizabeth

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.