ADaM

Hi all,

Is there an expected timeline for when P21 (Enterprise and Community) will support validation of ADNCA as a separate Subclass, instead of as a generic BDS?  The only information I could find on the Pinnacle 21 website was a blog post from January 2022 indicating that support was in progress, but that was obviously several years ago.

Thanks,
   Nancy

Hello,

I identified an issue with rule AD0018 - variable label mismatch for variable SRCSEQ. Per ADaM IG v1.2 the label of SCRSEQ is "Source Sequence Number" and I used this label but receive this warning. Is the check wrong?

Best regards,

Matthias Lehrkamp 

I am using the Pinnacle 21 Enterprise version, and I want to extract the compressed ADaM package (SAS dataset (.xpt), Define.xml, ADRG (PDF), define2-0-0.xls) uploaded to P21E.

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