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Differences in number of Error/Warning with same CT between P21C v2.1.3 and v3.0.2

y Yuichi
 on June 11, 2020

 

I am currently using P21C both v3.0.2 and v2.1.3 whose engines are legacy PMDA.

When I run P21 checks to SDTM with CT version 2012-12-21, 2018-12-21 respectively with P21C v3.0.2 and v2.1.3,

I have seen huge gaps in each results.

 

Here's a summary of number of errors from our SDTM packages.
figure 1

 

 

 

 

 

This seems that v3.0.2 doesn't apply CT 2012-12-21 correctly.

Actually SDTM was formatted by CT 2012-12-21 and we expect less number in v3.0.2 with CT 2012-12-21.

 

This issue was found in several people in my groups.

 

Does this look normal behavior of v3.0.2 ?

 

Thank you in advance.

Forums: SDTM

Sergiy
on June 11, 2020
P21

Hi Yuichi, 

Could you provide examples of extra validation errors and warnings in Community 3.0.2?

Thank you,
Sergiy

y Yuichi
on June 11, 2020

Dear Sergiy,

Thank you for your reply.

For example, CT2001: "AEACN value not found in 'Action Taken with Study Treatment' non-extensible codelist" and CT2003: "VSTESTCD and VSTEST values do not have the same Code in CDISC CT" were not found in v2.1.3 with CT 2012-12-21 but it appears in v3.0.5 with CT2012-12-21.

Best regards.

   Yuichi

Sergiy
on June 11, 2020
P21

Hi Yuichi, 

I cannot reproduce your case. Using Community 2.1.3 with SDTM CT 2012-12-21, I get validation message "AEACN value not found in 'Action Taken with Study Treatment' non-extensible codelist"

Please ensure correct installation of CT files. For example, after downloading CT files for Community 2.1.3 from Pinnacle 21 website (https://www.pinnacle21.com/downloads/cdisc-terminology), you need to rename them as "SDTM Terminology.odm.xml"

Kind Regards,
Sergiy

 

y Yuichi
on June 12, 2020

Thanks Sergiy.

Actually I tried to use installed CT. Applied CT (2012-12-21) to both v2.1.3 and v3.0.2. Results are quite different as above.

For more detail, AEACN = "NONE", "PERMANENTLY DISCONTINUED" and "TEMPORARILY INTERRUPTED" fires ERROR in v3.0.2 but doesn't in v2.1.3...

 

Sergiy
on June 12, 2020
P21

Hi Yuichi, 

Installation of CT files to Community 3.x is automatic. This functionality is introduced to ensure right process.

Incorrect manual configuration of system by inexperienced users in Community 2.x was the most common source of problem.

As you can see from your results, your validation by Community 2.1.3 does not produced expected outcome due to many unreported data issues related to CDISC Terminology. That's why I assume that you have incorrect installation of CT files.

Why are you still using Community 2.1.3?

Thank you, 
Sergiy

  

y Yuichi
on June 12, 2020

Ok, if P21C v3.x is running correctly, that won't be any problems.

 

The reason why I keep using v2.1.3 is because PMDA submission whose NDA date is in coming months.

I have prepared eCRT for a year and has to complete them with v2.1.3.

I think, at least by end of this year, some Pharma company in Japan will keep use v2.1.3.

 

Thank you and regards.

 

Sergiy
on June 12, 2020
P21

Hi Yuichi,

A whole point of 3.x is to help users with correct installation and configuration of Community validator.

If you have different results from Community 2.1.3 and Community 3.x with 1511.6 engine, I will always trust 3.x rather than 2.1.3. From your example you can see that 2.1.3 does not produce correct validation results. PMDA will validate your study data using engine 1511.6. They do not use Community 2.1.3. Therefore, I do not understand why some companies would prefer Community 2.1.3.

Kind Regards, 

Sergiy 

y Yuichi
on June 14, 2020

Thank you Sergiy, I agree with you.

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