SDTM

Hi!

According to the new SDTMIG 3.2 the coding variables are not yet in the parent domain PR. I have a case where I have coding variables given for a procedure (surgery). Is it allowed to put it into PR or do I have to use SUPPPR for this? I think one can think about implementing it into the parent domain (the same that was done for AE for example).

Thanks!

Hello everyone,

We have an existing source location for our MedDRA databases.  We are planning to install OpenCDISC into the same application environment with access to the MedDRA databases.  Is there a way to configure OpenCDISC to point to this centralized network folder, rather then copying the MedDRA information into the OpenCDISC application folder structure?

Best regards,

John

Hi!

I have a PR Domain (SDTMIG 3.2) where I also would need to put some coding variables (the same as in AE such as LLT, HLT, etc) regarding the procedure used. Not sure if this is allowed for Interventions? Or is it possible to put them into SUPP?

Thanks in advance!

Hi,

It's for a custom Events domain, let's call it XE.  The validator complains that XEDECOD would be a required variable, and it's not found; SD0056. (We have --TERM, and we don't use --DECOD.  That should be permissible, just like it is permissible in MH.) I think this is a bug.

Second issue.  We have --PRESP and have --OCCUR. We are getting SD1073, that XEOCCUR is variable prohibited for use in SDTM. Again, I think it is a bug for the custom events domain.

The validator flag occurred with or without define.xml file. Same either way.

Dear all,

I think it makes sense to check for duplicated AE records, but AEDECOD contains the preffered term, which can be equal for two different AEs.

E.g.:

AELLT = Abdominal discomfort has AEDECOD = Abdominal discomfort
and
AELLT = Stomach upset also has AEDECOD = Abdominal discomfort

I would suggest to use AELLT instead of AEDECOD for this kind of check.

Best regards,

Nicola Tambascia

Hi,

I have a question to the date/time format in SDTM where, for example, the day or month are unknown, but time is collected. Can I map it to 2006T03:34 for example (so here I only have known year and time?). I haven't found such a case in the SDTMIG.

Thanks in advance!

Hi,

I have a question regarding adding a variable to the EX domain. I know that timing variables can be added to the EX domain, but what about EXSTAT for example? It is not yet covered by the SDTMIG.

Thanks in advance!

We should add a similar check for DM.ARM and DM.ACTARM.

Thanks.

These checks should be changed to work with DM.ACTARM/DM.ACTARMCD instead of DM.ARM/DM.ARMCD as a randomized subject may not be treated.

Thanks.

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.