SDTM

Rules SD1057-SD1059 - Non-recommended variable length for certain TEST and related variable values - expects the variable lengths to equal the max allowable. This is inconsistent with the "CDER Common Data Standards Issues" request for field lengths to be adjusted to the max found in the field, in order to reduce file sizes. Rather than testing whether the field length equals the max, shouldn't the check be that the field length doesn't exceed the max?

Please note the Events class has been extended to include --LLT, --LLTCD, --PTCD, --HLT, --HLTCD, --HLGT, --HLGTCD, --BDYCD, --SOC, and --SOCCD.  It does not seem as if the extension is limited to AE (see pg. 3 amendment 1 list [vers 1.0 final]).  Since MH and CE terms can be MedDRA coded, should SD0058 be updated for Amendment 1?  As of now, it triggers a warning for MH and CE for the MedDRA hierarchy terms.   Thank you

Joan

The check for consistent value for LBSTRESU within a lab test LBTESTCD should permit differentiating by specimen type and method.  Note, if the differentiation has been allowed in a beta version of the configuration it is not yet available through a site update, or on the svn.opencdisc.org configuration source site for updates.  Thank you.

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. :(