A few problems with v3.1.2

Pinnacle 21 Support SDTM
1

Hi Karen,

Thanks for your feedback. Here are some comments/questions:

  1. This issue has been resolved in the latest maintenance release v1.0.1, which can be downloaded at http://www.opencdisc.org/download
  2. We couldn’t reproduce this issue, could you tell me in which domain TAETORD is set to Length=“200”?
  3. This has been confirmed as a bug, we will address it in the next maintenance release
  4. Currently if a variable has a user-defined codelist and CDISC controlled terminology, then it’s checked against both. So in cases of extensible codelists, the variable will pass the user-defined codelist check but will show warnings for CDISC terminology check. We are planning to enhance this in a future version of the Validator, so that only the user-defined codelist is checked.
  5. Duplicate checking for USBJID is done with rule SD0083
  6. Same issue as in item #4

Regards,
Max

2

Hi, Max. Thanks for explaining how #4 works. For item #2, I experienced this problem in the TA domain. Thanks, Karen

3

Max, I believe SUBJID does not have to be unique. Only USUBJID does. Perhaps rule SD1001 should be deleted. thanks again, Karen

4

Hi Karen,

The SUBJID variable must also be unique. The difference between USUBJID and SUBJID is that the USUBJID needs to be unique across all studies within the submission, while SUBJID needs only to be unique within the study. Check out SDTMIG v3.1.2, page 54.

Regards,
Max

5

How right you are. I must have always worked with unique SUBJIDs and never noticed this until now. Thanks! Karen

6

Hi… I’m using v3.1.2. It’s very good, but there are a few problems:

  1. The Define file generator crashes if a codelist is referenced on the “CodeList Assignments” tab but is not present on the “CodeList Definitions” tab.

  2. The Define file generator seems to make TAETORD text length 200 even if it is numeric in the input file.

  3. Rule SD0037: Does not recognize codelist values with embedded double quotes.

  4. Rule CT0037: Should use user-defined codelist if present, not SOC.

  5. Rule SD1001: This rule should use USUBJID, not SUBJID.

  6. Rule CT0029: Values added to the extensible codelist RACE are being incorrectly flagged as an error. This may be a general problem.

Thanks for your help.