SD0063 OpenCDISC rule

Pinnacle 21 Support SDTM
1

Hi Adela,

These labels in OpenCDISC specifications look identical to SDTM IG. Reported issues could be due to many reasons. For example, leading or trailing space characters, extra space characters, character case mismatch, etc.

You can email to me empty datasets for diagnostics.

Kind Regards,

Sergiy

sergiy (at) opencdisc (dot) org

2

Hi Sergiy,

Just a follow up to see what was the outcome of the above question?

I ran the QS domain through the latest version of the validator( 2.0.1) get the same error for QSSTRESC. Character Result/Finding in Std Format. The label is correct per CDISC.

Thanks,

Darshan

3

Hi Darshan,

The Label specification in system configuration looks fine. I run many validations from different studies and sponsors, but have never seen this false-positive message reported by you.

Sample dataset with 0 observations would be helpful for diagnostics.

Thanks,

Sergiy

4

Dear Raja,

Please be aware that OpenCDISC checks the labels case sensitive and byte by byte. Even an hidden carriage return or tab or any other character (byte) that is not displayed may lead to a “false positive”.

I.m.o. users should be allowed to slightly change the label for variables (i.e. deviate from what is in the IG). I have seen many cases where the sponsor wanted to slightly change the label to make it more descriptive (i.e. the reviewer is given a considerably better description of what the variable is about), but this gave errors in the validator so that the sponsor then returned to the label as in the IG, although it did not very well describe what the variable is about.
But that is of course my personal opinion…

5

Hi,

I think it is due to that in SDTM IG 3.2 the label for QSSTRESC is set to:

“Character Result/Finding in Standard Format”

which is 43 character long, and not allowed

In previous versions e.g. 3.1.3 the label was

2Character Result/Finding in Std Format"

6

Hi Linda,

You are right. SDTM IG v3.2 has many variables with invalid Labels >40 chars long. In the next release of OpenCDISC Community we are replacing those invalid variables with “generic” as defined in SDTM Model. For example, “Character Result/Finding in Standard Format” → “Character Result/Finding in Std Format”.

Variable Label in SDTM IG 3.2 Length Corrected Label in OpenCDISC
FALAT Laterality of Location of the Finding About 43 Laterality
HODECOD Dictionary-Derived Term for Healthcare Encounter 48 Dictionary-Derived Term
HOSTDY Study Day of Start of Healthcare Encounter 42 Study Day of Start of Event
ISSTRESC Character Results/Findings in Std. Format 41 Character Result/Finding in Std Format
MHREASND Reason Medical History Not Done or Not Occurred 47 Reason Not Done
MISTRESC Character Result/Finding in Standard Format 43 Character Result/Finding in Std Format
PCSTRESC Character Result/Finding in Standard Format 43 Character Result/Finding in Std Format
PESTRESC Character Result/Finding in Standard Format 43 Character Result/Finding in Std Format
PPSTRESC Character Result/Finding in Standard Format 43 Character Result/Finding in Std Format
QSSTRESC Character Result/Finding in Standard Format 43 Character Result/Finding in Std Format
SRSTRESC Character Results/Findings in Std. Format 41 Character Result/Finding in Std Format

However original discussion was about SDTM IG 3.1.3 which does not have such problem.

Kind Regards,

Sergiy

7

Dear Sergiy,

As per your last comment, you wanted to update the labels > 40 char as per SDTM Model. However, if I look into SDTM Model 1.4 the label for STRESC is “Result or Finding in Standard Format” and not “Character Result/Finding in Std Format”. Was this already updated accordingly?

Thanks in advance!

Manolya

8

Hello,

When running the validator 2.0.1 the OpenCDISC rule SD0063 gives the error SDTM/dataset variable label mismatch in IE and QS (QSSTRESC, Character Result/Finding in Std Format) and (IETESTCD, Incl/Excl Criterion Short Name) when data shows;

Character Result/Finding in Std Format

Inclusion/Exclusion Criterion Short Name

when SDTM IG 3.1.3 request for



Inclusion/Exclusion Criterion Short Name

Thanks

Adela