ADaM

Hi,

We have a parameter in ADQS dataset and we are peforming deriviation based on certaim condition if iresult missing from source - and we want to show NULL values in the listings so kept missing AVAL and AVALC results - and few observations derived and populate PARAMTYP for same parameter and I observed below error message in Open CDISC log file - Does it okay if we submit this obsevations in the ADaM submission or do we need do drop observations which has AVAL or AVALC is NULL -Appreciate your inputs.

Hi,

Not all subjects will provide full birth date - we do expect partial dates - so it should allow null values in AGE but I see be;low error message - Appreciate your view.

Thnaks,

Venkata Maguluri.

Hi,

I was runing ADaM validation checks and found below issue - i think its misfiring (we applied labels as described in ADaM metadata)  I appreciate your suggestions.

- Thanks

Venkata Maguluri

I am proposing to remove rule OD0080 from OpenCDISC, at least in ADaM.  I am also proposing to expand CodeList and CodeListRef definition in define.xml but that is a different topic.

Normally in ADaM domains we create both CODE and DECODE variables, for example, TRT01P and TRT01PN. This is not normally done in SDTM.

Consider the following code list - numeric code, short text and long text.

1 = 'A' = 'Investigational Drug'

2 = 'B' = 'Placebo'

Hello,

Since the ADaM Data Structure for Adverse Event Analysis was released last May, there is no requirement for PARAM, PARAMCD and AVAL/AVALC to be present in ADAE.  Is there any plan to prevent these errors from firing in ADAE or at least degrading them to warnings?

Thanks!

Hello,

This message comes up repeatedly as an Error finding, for valid label text for TRTSDT, TRTEDT, PARCAT1N, CRIT1, CRIT2, CRIT3, ..., CRIT1FL, CRIT2FL, ... .  I sent an email to you also, with screenshot.

AD0018 is being tested also against custom added variables, for which I don't believe the check should be applied.

Can this be addressed? Thank you for all the hard work!

- Joan

I have a BDS dataset with the following incorrect labels

AVALC - Analysis Value, Char

BASEC - Baseline Value, Char

so I would expect rule AD0018 to fire. However, this rule seems to only fire for the ADSL dataset.

Based on your metadata file having the Domain Column = BDS, I noticed that when I renamed my dataset to BDS this rule seemed to work.

Is there any other work around or is this something that will be resolved in an upcoming release?

thanks!

Hi,

I'm able to run OpenCDISC on SDTM datasets, without any problems.  However, I'm experiencing difficulties running OpenCDISC to validate ADaM transport files for define.xml.  I've tried a couple different runs: (1) running all ADaM datasets + SDTM DM + SDTM EX.  (2) running just ADSL + SDTM DM + SDTM EX.

Below are the errors encountered for test (2).  Are other SDTM datasets needed besides DM and EX for ADaM OpenCDISC runs?  Any help you can give would be appreciated.  Thanks.

Mike

Dear ADaM support team,

We got the following error in our ADLB dataset.