SD0031 Error with PC dataset??

d David

on November 17, 2010

Hello

I am not sure if the rule SD0031 can be modified or not. However within the PC domain there is a variable PCDTC which is the date of the specimen collection and PCENDTC which is the end date. When ENDTC is present the program seems to look for a STDTC value. But this is not an allowable variable in the PC domain just PCDTC. So we have data like this below:

PCDTC PCENDTC

2010-06-07T05:45:05 2010-06-07T05:45:05
2010-06-07T07:15:01 2010-06-07T07:15:01
2010-06-07T07:30:05 2010-06-07T07:30:05
2010-06-07T07:45:01 2010-06-07T07:45:01
2010-06-07T08:00:06 2010-06-07T08:00:06
2010-06-07T08:30:01 2010-06-07T08:30:01

It appears as if this is a false positive result. I would appreciate a comment on this.

Thanks!

Forums: SDTM

l Linda

on November 18, 2010

I noticed the same problem

I noticed the same problem yesterday, and would also like see others comments on this.

m Max

on November 18, 2010

P21

Re: SD0031 Error with PC dataset??

Hi David,

You are correct, SD0031 should not apply to PC or any other Findings domain.

Per SDTMIG v3.1.2 section 4.1.4.8 (page 44), --STDTC should not be used in Findings domains to capture start date/time of collection. Instead --DTC variable should be used, and there is already rule SD0024 that makes sure that you are not missing --DTC when --ENDTC is populated.

I'm going to file a bug report with our team to remove rule SD0031 from all Findings domains in the upcoming Validator configurations release. However, in the meantime you can remove/disable this rule by finding the following statement under each Findings domain and removing it or setting the Active attribute to "No"

<val:ValidationRuleRef RuleID="SD0031" Active="Yes"/>

Thanks for the feedback,
Max

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