ADaM

Pinnacle 21 ADNCA support

Nancy — Wed, 26 Feb 2025 15:50:06 +0000

Pinnacle 21 ADNCA support

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

n Nancy

February 26, 2025

Forums: ADaM

Trevor

on February 27, 2025

P21

Hi Nancy, P21C has support…

Hi Nancy,

P21C has support for ADNCA as recent as Engine 2304.3, but it's limited to ADaMIG 1.3 only.
P21E has support for ADNCA as recent as Engine 2304.0, and is also limited to ADaMIG 1.3 only.

Right now, support is limited to a dataset named "ADNCA" explicitly. That is because we needed to make some changes in our validator to support more complex Prototype logic for matching datasets to a Class and SubClass. Those enhancement were done, and we are looking to move support for ADNCA to be a dynamic approach (like BDS, OCCDS, etc.) where we assume it's class + subclass based on the presence of required variables.

I hope this helps,

Trevor

AD0018: Variable label mismatch for SRCSEQ

Bayer AG — Wed, 15 Jan 2025 12:09:17 +0000

AD0018: Variable label mismatch for SRCSEQ

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

b Bayer AG

January 15, 2025

Forums: ADaM

How to export ADaM package (zip)

Jane — Thu, 26 Dec 2024 06:42:28 +0000

How to export ADaM package (zip)

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.

j Jane

December 26, 2024

Forums: ADaM

Sergiy

on December 27, 2024

P21

P21 Validator does not store study data

Hi Jane,

For Enterprise questions please contact P21 Enterprise Support.

We do not store ZIP file uploaded to Enterprise. After completion of the validation all study data are automatically deleted.

Kind Regards,
Sergiy

AD0018: Variable label mismatch between dataset and ADaM standard (ASEQ)

Peng — Tue, 26 Nov 2024 16:09:06 +0000

AD0018: Variable label mismatch between dataset and ADaM standard (ASEQ)

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

p Peng

November 26, 2024

Forums: ADaM

j Justin

on November 27, 2024

P21

RE: AD0018: Variable label mismatch

Hi Peng,

Thanks for reaching out! This forum posts looks like it's related to a data package in P21E so I will create an ESD ticket for this request. You will receive an email notification once this has been created.

Kind regards,

Justin

p Peng

on December 3, 2024

Thank you!

b Bayer AG

on February 7, 2025

Same issue

Hi,

I still have the same issue. When will it be fixed?

Best regards,

Matthias

Sergiy

on February 7, 2025

P21

Hi Bayer, What versions of…

Hi Bayer,

What versions of validation engine and ADaM standard do you refer? This issue may exist in 2405.0-1, but was fixed in 2405.2.

Thanks,
Sergiy

b Bayer AG

on March 5, 2025

Hi Sergiy, The new version…

Hi Sergiy,
The new version seems not available for us.
Thank Matthias

File Upload

Pinnacle 21 validation engine

Sergiy

on March 5, 2025

P21

2405.2 engine is available…

2405.2 engine is available for Enterprise clients now.

Community release of 2405.2 engine is scheduled for the next week.

screenshot-2024-11-26-110838.png

ISS: multiple records in IADSL and IADAE

Meiyi — Mon, 14 Oct 2024 19:37:00 +0000

ISS: multiple records in IADSL and IADAE

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?

Will FDA accept or reject when ADSL or IADSL has multiple records for one subject? (Our current ISS IADSL structure is one record per subject per pool).

For ISS ADAE:

Will FDA accept or reject when we name it as IADAE instead of ADAE?

Will FDA accept or reject when ADAE or IADAE has multiple records for the same AE starting on the same day for one subject?

m Meiyi

October 14, 2024

Forums: ADaM

AD0047 --SEQ false positive. Validation engine 2405.0

Bartosz — Mon, 16 Sep 2024 10:16:00 +0000

AD0047 --SEQ false positive. Validation engine 2405.0

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?

b Bartosz

September 16, 2024

Forums: ADaM

Matt

on September 19, 2024

P21

Hello Bartosz, This…

Hello Bartosz,

This appears to be an Enterprise related question. I will create the appropriate ticket on your behalf and follow up there.

Kind regards,

Matt

o Oliver

on September 20, 2024

Issue started after recent engine update

Hi,

Are AESEQ and xxSEQ always been required variables in P21E ADAM IG 1.1? I see that in our P21E, ADAM IG 1.1 was recently updated on 26Aug2024.

After engine update, we are getting AD0047 false positive error on xxSEQ variables, existing in dataset but flagged as missing in P21E.

AESEQ and xxSEQ now required in P21E ADAM IG 1.1 -- not clearly stated in the ADAM IG 1.1 pdf from Dec2016.

Thank you for your help.

Oliver

AD0245 - CNSR is present, but STARTDT is not present

Elizabeth — Mon, 12 Aug 2024 15:45:05 +0000

AD0245 - CNSR is present, but STARTDT is not present

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

e Elizabeth

August 12, 2024

Forums: ADaM

Suggest: Label for acat01/02/04

Priyanka — Wed, 03 Jul 2024 14:46:28 +0000

Suggest: Label for acat01/02/04

Hi Team,

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

p Priyanka

July 3, 2024

Forums: ADaM

Matt

on July 3, 2024

P21

Hello Priyanka, This…

Hello Priyanka,

This appears to be P21 Enterprise related so I will follow up with you via our Enterprise Support Desk.

Kind regards,

Matt

acat01.jpg

AD0196: Required AVALU value is null, ADNCA

Dana — Tue, 25 Jun 2024 12:20:53 +0000

AD0196: Required AVALU value is null, ADNCA

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

d Dana

June 25, 2024

Forums: ADaM

AD0018: Variable label mismatch, ATOXDSCH/L

Dana — Tue, 25 Jun 2024 09:32:01 +0000

AD0018: Variable label mismatch, ATOXDSCH/L

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

d Dana

June 25, 2024

Forums: ADaM

h Harald

on December 9, 2024

Dear all, we ran into the…

Dear all,
we ran into the same issue. I would suppose that we have an issue with the ADAM 1.3 config XML, as the specs state:

           <ItemDef OID="IT.ADNCA.ATOXDSCH" Name="ATOXDSCH" DataType="text">
                <Description>
                    <TranslatedText xml:lang="en">Analysis Toxicity Description High</TranslatedText>
                </Description>
            </ItemDef>
            <ItemDef OID="IT.BDS.ATOXDSCH" Name="ATOXDSCH" DataType="text">
                <Description>
                    <TranslatedText xml:lang="en">Analysis Toxicity Description High</TranslatedText>
                </Description>
            </ItemDef>
            <ItemDef OID="IT.MDBDS.ATOXDSCH" Name="ATOXDSCH" DataType="text">
                <Description>
                    <TranslatedText xml:lang="en">Analysis Toxicity Description High</TranslatedText>
                </Description>
            </ItemDef>
            <ItemDef OID="IT.ADNCA.ATOXDSCL" Name="ATOXDSCL" DataType="text">
                <Description>
                    <TranslatedText xml:lang="en">Analysis Toxicity Description Low</TranslatedText>
                </Description>
            </ItemDef>
            <ItemDef OID="IT.BDS.ATOXDSCL" Name="ATOXDSCL" DataType="text">
                <Description>
                    <TranslatedText xml:lang="en">Analysis Toxicity Description Low</TranslatedText>
                </Description>
            </ItemDef>
            <ItemDef OID="IT.MDBDS.ATOXDSCL" Name="ATOXDSCL" DataType="text">
                <Description>
                    <TranslatedText xml:lang="en">Analysis Toxicity Description Low</TranslatedText>
                </Description>
            </ItemDef>
            <ItemDef OID="IT.ADAE.ATOXGR" Name="ATOXGR" DataType="text">
                <Description>
                    <TranslatedText xml:lang="en">Analysis Toxicity Grade</TranslatedText>
                </Description>

It currently expects special characters resembling a blank rather than a regular blank.

@P21-Team: I suppose this is a known issue likely to be fixed in next engine release?

Kind regards,

Harald

j Jozef

on December 9, 2024

AD0018: Variable label mismatch, ATOXDSCH/L

OMG ...
In XML, one never replaces blanks by entities like  
I presume the reason that it appears like this in the config XML file, is that someone, with little knowledge about XML, generated it e.g. from an Excel file.
Can you edit the ADAM 1.3 config XML yourself, and replace all " " by real blanks?
In my distribution, it is under "C:\Program Files (x86)\Pinnacle 21 Community\resources\app.asar.unpacked\components\lib\configs\2304.3"
To do so, you can simply use NotePad++.
Do NOT use Word or Excel or so!

j Justin

on January 8, 2025

P21

AD0018: Variable label mismatch

Hi Harald and Dana,

I can confirm that there is known bug with the mentioned labels that is fixed in a future Engine suite. These instances of AD0018 can be explained in the ADRG for the time being.

Hope this helps clear things up.

Kind regards,

Justin

ad0018_atoxdsc_0.jpg