s Snehal
on

 

Hi there,

I have a question regarding validation of ADaM domains like ADMH, ADCM, ADAE. As per new ADaM_OCCDS_v1.0 released in Feb 2016, ADMH, ADCM, ADAE should come under "OCCDS" class instead of "BDS" class, but when I ran the latest community version of Pinnacle validator (2.2.0) using ADaM 1.0.xml config file,  ADMH and ADCM domains are getting validated under "BDS" class and ADAE under "ADAM other". Why is it so? when can I expect the updated config file for ADaM datasets?

Please see attached the snippet from the summary page of validation report that is getting generated. 

 

Forums: ADaM

s Sergiy
on January 16, 2017

Hi Shehal, 

I agrre with you. However, see the following discussion: https://www.pinnacle21.com/forum/dd0055

Regards, 

Sergiy

s Sergiy
on January 16, 2017

For validation we are following official ADaM rules published by CDISC team. There is no formal business rules for OCCDS. Therefore, there is no actual diffrence between ADaM OTHER and OCCDS in terms of validation itself.  

s Snehal
on January 20, 2017

Thanks Sergiy for your response, our understanding from above response/disussion is that ADCM, ADMH would be classified under BDS until CDSIC publishes new formal business rules for this class (OCCDS). please confirm..

s Sergiy
on January 20, 2017

According to ADaM, BDS datasets must include PARAM/PARAMCD/AVAL variables. This is not the case for common implementations of ADCM, ADMH datasets.

s Snehal
on January 25, 2017

summary report

But, 

still it is not clear to me that why the config file is treating ADCM, ADMH and ADDV as BDS datasets rather than ADaM OTHER, and why it does not recognise ADRACE at all. Please see the attached image of the summary report

s Sergiy
on January 25, 2017

Hi Snehal, 

I assume that it's due to the use of ASTDT variable in your ADCM dataset. In this case your complain is perfectly valid. Current definition of BDS structure in P21 Validator includes a presence of ASTDT and ASTDTM variables. We are discussing removing these variables from our definition of BDS structure.

Meanwhile, you can manually modify P21C specs by removing highlighted text from validation configuration files. For example, there is a file "ADaM 1.0.xml" in "...\components\config" folder. Open it by any plain text editor and find the following definition of BDS structure on row 2369:

<val:Prototype ItemGroupOID="IG.BDS" KeyVariables="PARAMCD,PARAM,AVAL,AVALC,ADT,ASTDT,ASTDTM,CNSR,CNSDTDSC,EVNTDESC"/> 

Remove highlighted text, save, restart Validator.

Regards, 

Sergiy

s Snehal
on February 6, 2017

Hi Sergiy,

Thank you for your response, that answers my question. We look forward to an updated configuration file.   

Regards,

Snehal

s Snehal
on February 8, 2017

new_report

Hi Sergiy,

I tried manually removing the ASTDT, ASTDTM from key variables in the ADaM config file but it didn't solve the issue, ADCM, ADMH are getting "unrecognized".  Please refer the above image for the report.

Thanks,

Snehal

 

s Snehal
on March 21, 2017

Hi Sergiy,

We tried manually editing the ADaM config file by adding configuration for some of the domains (e.g ADCM, ADMH), we edited the current prototyping options and added CM and MH specific variables, then mapped them to "other" custom built configuration/validation rules and it worked fine, we could get these domains classified as "OTHER". Do you have any alternative suggestion to this approach?,

 

h Hanna
on June 2, 2017

We have developed our ADCM, ADMH as OCCDS; as per the ADaM IG 1.1 (and ADaM_OCCDS_v1.0). When running through the validator (v2.2.0) we get errors and as I read other posts in this thread I just want you to confirm;

Do we have to update the config file to not treat these datasets as BDS? If yes, can you please guide me exact what to update?

Can we expect an update in the config file for OCCDS datasets in a coming release of Pinnacle validator? I have understood the CDISC team has not yet released any formal business rules for OCCDS.

regards Hanna

s Sergiy
on June 2, 2017

Hi Hanna, 

The CDISC ADaM team has not yet published rules for ADaM 1.1, but they are working on getting it done by the end of Q2. Once the rules are published, Pinnacle 21 plans to make the config available within 3 month. So end of September is the current estimate, assuming CDISC stays on schedule.

Kind Regards, 

Sergiy

s Snehal
on June 14, 2017

Hi Sergiy,

Assuming CDSIC stays on schedule, can we expect the issues with ADRACE (getting unrecognized), and ADCM/ ADMH /ADDV/ ADMH (OCCDS datasets getting validated as BDS) to be fixed by September end??

Looking forward to your reply.

Thanks,
Snehal

j John
on March 14, 2018

So I've been monitoring the releases for Pinnacle 21 community.. will there be a ADaM.1.1 configuration release?

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