SD1201: Duplicate USUBJID/AEDECOD/AESTDTC record

Pinnacle 21 Support SDTM
1

Hi Nicola,

SD1201 check already includes a --LLT variable. However SDTM IG 3.1.2 standard does not have this variable and it leads to False-Positive Messages.

You should not have reported issues if you are validating SDTM 3.1.3 by OpenCDISC v1.4.1. Please confirm if it’s not true.

Thank you,

Sergiy

2

Hi Sergiy,

I used the config file for 3.1.3 and OpenCDISC v1.4.1 and got this issue.

Best regards,

Nicola

3

Try changing following code (in bold) in /config/config-sdtm-3.1.3.xml file:

<val:Unique ID=“SD1201” Message=“Duplicate USUBJID/%Domain%DECOD/%Domain%STDTC record” Description=“The structure of Events class domains should be one records per Event per subject. No Events with the same Decoded Term (–DECOD), Category (–Cat), Subcategory (–SCAT) and MedDRA Low Level Term (–LLT) values for the same Subject (USUBJID) and the same Start Date (–STDTC) are expected.” Category=“Consistency” Type=“Warning” Variable=“%Domain%STDTC” When=“%Domain%DECOD != ‘’” GroupBy=“USUBJID,%Domain%DECOD,%Domain%CAT,%Domain%SCAT**,%LLT**” Optional=“%Domain%CAT,%Domain%SCAT**,%LLT**” />

<val:Unique ID=“SD1201” Message=“Duplicate USUBJID/%Domain%DECOD/%Domain%STDTC record” Description=“The structure of Events class domains should be one records per Event per subject. No Events with the same Decoded Term (–DECOD), Category (–Cat), Subcategory (–SCAT) and MedDRA Low Level Term (–LLT) values for the same Subject (USUBJID) and the same Start Date (–STDTC) are expected.” Category=“Consistency” Type=“Warning” Variable=“%Domain%STDTC” When=“%Domain%DECOD != ‘’” GroupBy=“USUBJID,%Domain%DECOD,%Domain%CAT,%Domain%SCAT**,%Domain%LLT**” Optional=“%Domain%CAT,%Domain%SCAT**,%Domain%LLT**” />

4

changing the code in config-sdtm-3.1.3-xml solved the problem. Now only the two real cases I have in the data remain. Thanks for solving this.

Will this be changed in following OpenCDISC versions?

Thanks again and best regards,

Nicola

5

Hi Nicola,

Many thanks to Nitin for helping with this issue clarification!

Actually the SD1201 “LLT” bug was found and fixed just after a release of 1.4.1. Unfortunately I’ve already forget about it and did not review the check history. I am using different OpenCDISC Enterprise applications. They have most recent updates which are waiting for the next release of the free version.

BTW, there will be (is) an additional change in SD1201 check. --SEV and --TOXGR variables were added to handle a case when a new Event is due to an increase in Severity/Toxicity on the same date/time.

Thanks to all!

Regards,

Sergiy

6

Dear all,

I think it makes sense to check for duplicated AE records, but AEDECOD contains the preffered term, which can be equal for two different AEs.

E.g.:

AELLT = Abdominal discomfort has AEDECOD = Abdominal discomfort
and
AELLT = Stomach upset also has AEDECOD = Abdominal discomfort

I would suggest to use AELLT instead of AEDECOD for this kind of check.

Best regards,

Nicola Tambascia