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SD1135 for SDTM.EC
SergiyHi Anton, Thank you for…
Hi Anton,
Thank you for reporting this issue!
We will fix the rule algorithm by adding exception for --OCCUR='N' records and modify Description per your suggestion.
Thank you again!
Kind Regards,
Sergiy
SergiyThis is a follow-up
Hi Anton,
This is a follow-up for your original post and my initial feedback.
Your issue is a good example of complexity in data validation. After discussion of your case and request with other subject matter experts, we decided to not change current algorithm of SD1135 rule.
There are two competing and often opposite needs in terms of data validation. As a programmer, you want to reduce a number of validation messages which you consider as a false-positive ones. However, this interpretation is quite subjective and depends on intended use of validation results or study data in general.
Your case looks like some data collection issue due to subject protocol compliance problem. As a programmer, you cannot do anything to fix it and want to remove this issue from your "do to" list.
On the flip side, Reviewers want to be aware of presence any protocol compliance issues in the study. They want these issues to be reported and explained in Reviewers' Guide. "Negative study days for subject exposure" is an example of issues which definitely require their reporting and detailed explanation.
Kind Regards,
Sergiy
Hi Sergiy, That makes sense…
Hi Sergiy,
That makes sense. The issue in my study is indeed appeared due to protocol violence, but I have not considered it in this context. I realized that negative study days may appear in SDTM EC in a case when an occurrence is defined as 'No' (ECOCCUR = 'N'), and to report such an issue invalidation report seemed to me not logical.
Thus, the best solution is to describe the issue in Reviewer's Guide, do you agree?
With regards,
Anton
SergiyHi Anton, Yes, you need…
Hi Anton,
Yes, you need just document and explain this reported issue in Reviewer's Guide.
Kind Regards,
Sergiy
Hello,
In Pinnacle 3.1.0 in the validation report for SDTM, we have received the message 'Negative value of ECSTDY Study Day variable' (for ECENDY as well). As you see, message related to the EC dataset although rule SD1135 states 'Study Day variables (*DY) value should not be negative in Exposure (EX) datasets.'.
Please note, that the negative --DY variable could be possible in EC domain in case when ECOCCUR = 'N', which means that dose was not taken. In our case, SDTM.DM.RFSTDTC is the first dose taken date. The data in SDTM.EC says, that the first dose was not taken (ECOCCUR = 'N' and ECSTDY = -1), but the second dose next day was taken (ECOCCUR = 'Y' and ECSTDY = 1).
Could you please explain is it a valid validator issue?
Thank you,
Anton