SDTM

The upper case list of SOC values in the CDISC controlled terms file has been problematic and it is known to be at odds with MedDRA SOC, which is truly sentence case, e.g., Metabolism and nutrition disorders

The CDISC terminology work group has recognized the conflict and stated they intend to deprecate the SOC list from the terminology list in terminology Package 10; the SOC values can be found instead in the MedDRA dictionary. Therefore, the OpenCDISC check for all caps, and the warning message, is excessive.

Thanks,

Joan

I have a question on Unscheduled visits. If I come across any unscheduled visits in VS domain, LB domains etc .Do I need to send them into SV or do I need to populate them in the same domains (LB/VS) Please suggest me.

Should a re-screened patient keep the same subject ID or be assigned to a new Subject ID? What are the potential issues if the same subject ID is used?

Dear Members,

I`m just new in this process of SDTM and assigned the work of Medical Meaning.

Kindly make me clear that MM is part of SDtM or it`s just another thing.

Regards,

Nitin

Hi,

with the new OpenCDISC version 1.3 we are now getting the following warnings/errors that did not fire for the same datasets with version 1.2.1 and we also could not find any information in the SDTM IG 3.1.2 that justify those warning/errors:

Is there a way to invoke and run OpenCDISC in DOS batch from SAS?

Thanks,

Don.Hurst@Premier-Research.com

For some AE variables which are defined using Codelist (NY) the validator comes up with the WARNING SD1055:

The length of AE flags variables (AESER, AESCAN, AESCONG, AESDISAB, AESDTH, AEHOSP, AESLIFE, AESOD, AESMIE, AECONTRT) is expected to be 1.

The values for this codelist are "N", "Y", "NA" and "U".

When using the expeceted length of 1 I cannot use the NA.

Even if NA is not allowed for these variables, using length 1 in these variables there will be inconsistencies with other NY-variables in the database. :(

I need to create a custom doamin like (XB) for intervention and for that in CRF I have some values like commments(It's not free flowcomment) so is there any chance I can create custom variable if not how to represent them?

How to populate a country variable in DM doamin if it's not captured in CRF? please suggest

Hi OpenCDISC Team,

The error check SD1029 was added in the recently released v1.3 of the OpenCDISC Validator.

The rules define it as: