ADaM

Hi,

Could you please tell me what is happened for AD0033 - AD0036 rules?
Or in which scenario rules (AD0033 - AD0036) will work in Pinnacle21 validator.

Here is one example of AD0034 case. This situation is occurred for many CRT packages and I think this example is also happened in other company.

Dataset;
> 20 ADaM datasets with BDS and ADaM Other (+ define.xml). All ADaM datasets have ESPFL variable with Y/N terminology.

This question might be better aimed at CDISC, but I figure it couldn't hurt to ask here.

There are a couple of papers which offer guidance for avoiding the 1-1 mapping warning for AVAL and AVALC (AD0149/AD0149B). Things like:

https://www.lexjansen.com/wuss/2017/79_Final_Paper_PDF.pdf

https://www.pharmasug.org/proceedings/2012/DS/PharmaSUG-2012-DS16.pdf

For our study we need to keep some parameters from source SDTM dataset and some derived parameters in ADaM dataset.

But baseline variables BASE,BASEC,ABLFL are only needed for derived parameters. Is it okay to have them populated for few parameters and missing for most in the adam dataset?

Hi,

We are validating an ADaM submission against ADaM IG 1.1, and got AD0018-18 for the ANL01FL "Analysis Flag 01 - AE of Interest".
Per ADaM IG:

Descriptive text is allowed at the end of the labels of variables whose names contain indexes “y” or “zz”

Or are we missing something?

Cheers
-- Thierry

Hi, 

When trying to run validation engine 1511.6 (PMDA legacy) via CLI, I'm getting an error and empty excel report file. 

See below command used; can your provide the corresponding java command that allows this engine to run properly?

Hi Team,

As per the study design we have Maternal data captured for a study which is mapped to Associated persons domain i.e APDM ( Mother's also have the same USUBJID as of the babies). Can you please confirm which domain can we map the demographic details of the mothers in ADaM? As of now we have mapped to ADSL and created a flag as INFFL (for infants) and MOTHFL (for mothers) . However Pinncale is throwing error to say no duplicate USUBJID is allowed in ADSL and while cross validating with SDTM DM domain it is throwing errors to say ADSL.AGE != DM.AGE etc.

Hi,

As per ADAM IG , the variable label is assigned as Analysis Flag 01 for AN01FL variable, however we are getting an error in Community Pinnacle validator version. Can you please confirm what should the label be assigned as?

Dear all,

in a FDA submission relevant study we encountered the problem that the Vendor version (Enterprise 3.4.4) does not find the AD0366A Error (Missing value for RANDDT, when RANDFL is Y) whereas our Sponsor Community Version (the newest) state this as an error. I'd rather expect it the other way around.

Indeed, the RANDFL is available but not a RANDDT variable. The Vendor  does not accept this ERROR as it does not pop up in the Enterprise Version.

Is there anything I oversee ?

Many thanks for looking into this.

Hi there,

PVAL v3.0.1 is trigerring  "Dataset SV not validated" Error  for ADaM data validation. The sdtm datasets AE and SV has been used to check for any cross referencing issues.

Can you help us to identify the root cause for this error? I see that v2.2.0 of pval triggers this as 'Warning' as supposed to 'Error' in 3.0.1.

The config file used is ADaM-IG1.0(FDA).xml

Hi there,

Pinnacle report for community version 2.2.0 & 3.0.0 is showing an error CHG!=AVAL-BASE even though the calculated value of CHG is correct. Please refer the screenshot. 

Can you let me know if this is a known issue or is there any workaround for this?.

Thanks,

Ravish