SDTM

The rule SD0003, which checks for correct ISO8601 date strings is based on a regular expression, which is incomplete and does not cover all valid ISO8601 strings.

ISO8601 allows for a timezone expression, which indicates the difference between local time an UTC. This is indicated by "+/-hhmm" or "+/-hh:mm". Reference: ISO 8601 2004 standard at paragraph 4.2.5 (page 17-18). An example: "2009-09-23T00:00:00+01:00" .

Are there any example XPT files that have been created for testing the SDTM 3.1.2 or SDTM 3.1.1 versions?

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

I get SD0062 Incompatible data source error when I try to validate SDTM 3.1.1 dataset through the production release of the validator.  The .xpt file is a valid file as I can view it using SAS Viewer.  The error occurs with all the domains.  There is no log message in the trace.log and the error message is rather vague so I am not sure where to look for the source of the problem to try to fix the issue.  Please advise how to overcome this error.

Shouldn't this check take into consideration the LBCAT since there are tests that can span categories and end up having different standard units?

Thanks.

Hello Team,

SD0070 - No exposure record for subject is being output but the records in DM are SCRNFAIL (ARMCD). I think the check should be modified to ignore Screen Failures since they will not have a record in the EX domain.

David

Hello Team,

I did not use a define.xml file when I ran the checks (I don't have one) but I get the following warnings. These domains do not exist in the study I am running against OpenCDISC.

Hello,

THe excel output from OpenCDISC states that there is a problem with IETESTCD not matching TITESTCD but I checked and they both have valid values that match.

Regards,

David

Hi guys, I've finally got test data written for all the Janus/WebSDM checks except for the following few. In general, it looks pretty good.

Hi guys, I noticed that for a few checks, the Janus severity listed in your document doesn't match the severity listed in the document on the FDA website. Thought you'd want to know: IR4137 OpenCDISC = missing, FDA Website = Low IR4138 OpenCDISC = High, FDA Website = Check not listed IR4509 OpenCDISC = High, FDA Website = Medium IR4511 OpenCDISC = High, FDA Website = Medium IR4513 OpenCDISC = High, FDA Website = Medium R4008 OpenCDISC = High, FDA Website = Medium All WebSDM severity values matched. Thanks, Diane