SD0063 OpenCDISC rule

Hi Adela,  These labels in

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

QSSTRESC - Label

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

Hi Darshan,  The Label

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 

label

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....

Error in length of label

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"

Hi Linda, You are right.

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".

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

Kind Regards, 

Sergiy

SDTMIG 3.2. variable labels

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