SDTM Check SD0026

Pinnacle 21 Support SDTM
1

Hi Nitin,

The current algorithm of SD0026 check requires a non-missing value for --ORRESU, when a --ORRES value is populated and numeric.

There are additional exceptions for specific tests. E.g., --TEST=“…Ratio”, “…Antibody” and --TESTCD=“PH”,“SPGRAV”.

We are continuously tuning SD0026/SD0029 checks to minimize False-Positive messages.

Any advices and suggestions how to improve those checks are very welcome!

If I correctly understand, in your case ORRES/ORRESU are missing, while STRESC/STRESU/DRVFL are populated. Then you are not expected to receive any SD0026 messages. Please let us know if it’s not true.

Regards,

Sergiy

2

Hi Sergiy, In my case ORRES/ORRESU are missing, while STRESC/STRESU/DRVFL are populated but i am still receiving this message.

3

Most likely, there is something wrong with your ORRES value. E.g., it may include ‘.’ or invisible characters like space or carriage return.

4

No ‘.’ or spaces or tabs or carriage returns in ORRES. I double checked.

5

Found the problem in config files for 3.1.3 Just replace STRESC from below with ORRES -

<val:Required ID=“SD0026” Message=“Missing value for %Domain%ORRESU, when %Domain%ORRES is provided” Description=“Original Units (–ORRESU) should not be NULL, when Result or Finding in Original Units (–ORRES) is provided” Category=“Consistency” Type=“Warning” Variable=“%Domain%ORRESU” When=“%Domain%STRESC != ‘’ @and %Domain%STRESC @re ‘[-+]?[0-9].?[0-9]+’ @and !(%Domain%TEST @re '. Ratio’) @and !(%Domain%TEST @re ‘.* Antibody’) @and %Domain%TESTCD != ‘PH’ @and %Domain%TESTCD != ‘SPGRAV’” />

Thanks.

6

Hi Nitin,

You are absolutely right! It’s a bug introduced in v1.4.1 and your corrected syntax for the check SD0026 can be used as a temporary fixing solution.

Thank you very much for reporting this bug and your efforts for investigation of and fixing this problem!

Kind Regards,

Sergiy Sirichenko / OpenCDISC development team

7

Hi This is suppose to check for missing ORRESU when ORRES is not missing but it is also checking for missing ORRESU when STRESC is not missing. We have some derived tests so we set ORRES/ORRESU missing and only keep STRESC/STRESN/STRESU with DRVFL=Y. Please provide appropriate correction to config file. Thanks.