RuleID skip_AD0053

AD0053 is a LOOKUP rule

AD0053 is a LOOKUP rule against the SDTM DM domain file:

"Patient baseline and randomization combination not found in the SDTM Demographics domain.  If submitting SDTM with ADaM, there must be traceability"

I assume you are not submitting the DM file in your submission which is normal.  Is that correct ?

And which version of the validator are you using ?

Version of Validator 1.2.1

The ADaM Define is a standalone.

One other passing question...

The validator validate ADSL, but does nothing with the other ADaM datasets.  Is there some Class= or something that must be in the ADaM define for the itemgroupdef so that OpenCDISC knows that these other ADaM datasets are BDS datasets(BDS)?

the only configuration files

the only configuration files we tested with was the opencdisc-validator\config\config-adam-1.0.xml, which has ItemGroupDef GLOBAL, ADSL, BDS (which covers all BDS domains).

So are you using this file (config-adam-1.0.xml) with a custom define.xml file created for ADaM ?

the only configuration files

If you want to run a series

If you want to run a series of ADaM BDS files with ADSL, you need only select all your datasets and validate them:  config-adam-1.0.xml

You do not have to specify the optional define.xml file.   The screen should look like this:

What would you like to do?  - Validate Data

Standard: ADaM

Source Format:  SAS Transport (XPORT) or Delimited

Source Data:  (your ADSL and various BDS files only)

Configuration:  config-adam-1.0.xml

Define.xml (null)

Report Format: excel or csv

To date, we have not tested using an ADaM define.xml file

I have tried as you suggested

I have tried as you suggested above without the custom ADam Define and only the ADSL get validated.  

Perhaps I don't have genuine BDS files??  What does OpenCDISC look for to determine if a file is a BDS file?

For the OpenCDISC validator

For the OpenCDISC validator to recognize any file as a true BDS dataset (e.g. ADAE, ADLB, ADVS) , it must have at least of one these variables unique to BDS.   

PARAMCD,PARAM,AVAL,AVALC,ADT,ASTDT,ASTDTM

ADSL should never have any of these variables.

SKIP_AD0053

Hi,

I have the same problem with the SKIP_AD0053 and got following message

"The source data for DM is missing and cannot be used for cross-dataset validation". The SDTM DM was extra included into the same folder where all ADaM datasets for the validation checks were posted. My idea was, if the DM is there, these message wouldn't be preseted. But it was still there. Can you help on that?

Thanks, Natalie

SKIP_AD0053

Currently OpenCDISC validator doesn't know how to simply reference the DM file when it's in the same folder.   You actually have to select it for validation.   Try that and you should not get this error anymore.    And since DM won't match the format of ADSL or BDS, it shouldn't throw any errors on DM either.

We are working on a solution as to how to treat it like the other lookup files in the config\data directory

Please let me know how this turns out.