SDTM

Hi,

The IG for 3.1.3 and 3.1.2 has EXENDTC as permissible.  And that makes good sense for a per-instance recording scenario of an oral dose.

However, the validator is flagging an omitted EXENDTC column with the message, "SDTM Expected variable not found".

I recommend the configuration file be revised to treat EXENDTC as permissible.  Thanks!

Regards,

Joan

I get this message in EG domain. EGSTRESC value not found in 'ECG Result' extensible codelist

We keep values for QT intervals (numerics) in EGORRES/EGSTRESC I believe this follows the guidance to copy the values from EGORRES but CT2002 fires because the values are not in the codelist.

David

Hi, This should not apply to any DY variables (not talking about VISITDY) since FDA wants to see day calculated for all date variables. I see warnings for SESTDY/SEENDY using v2.0 for SDTM v3.1.3

Using OpenCDISC Community 2.0, I just noticed something odd about the message for the test SD2018/FDAC116.  I gather the purpose of this test is to guarantee that exactly one of TSVAL and TSVALNF is populated, with the other set to missing. 

We had data that accidentally triggered this test because both TSVAL and TSVALNF were non-missing--but the message for the test was "Missing TSVALNF value", and the description in the Rules tab is "Value for Parameter Null Flavor (TSVALNF) variable must be populated, when Parameter Value (TSVAL) variable value is missing."

Hi,

Does anybody know the difference between CT2003 and CT2006?

I am able to trigger CT2003, but I have problems triggering CT2006. If somebody can help identifying the difference between the two that would be really helpful.

Thanks,
Kind regards,
Hans

Hi, Can this rule be modified to exclude expected variables with length 1 with all values missing in SUPPQUAL domains like QEVAL (missing for CRF/Derived data) and IDVAR/IDVARVAL in SUPPDM (missing since DM has one record per subject) and ARMCD in TV (missing if all arms follow same visits) and TATRANS in TA (missing by protocol design).

In the new validator v2.0, the message "Variable length is too long for actual data" is becoming an error. I usually keep the length of each variable = the maximum length of all observations within that variable. What about the empty variables? The empty variables have a length of 1. But I keep getting the error messages “Variable length is too long for actual data”.

I notice that in the new openCDISC validator v2.0, the message "RACE value not found in 'Race' non-extensible codelist" is no longer a warning but an error.

Is there anyway to resovle this error? The RACE codelist does not have "MULTIPLE" or "OTHER" races, how should we handle people with multiple races?

Is there a reason why this message is changing from "warning" to "error" in the new validator?

 

Thank you!

 

Ceci

Hello,

Do you have any advice for users preparing submissions on interim data cuts, other than documenting this in the SDRG?

Interim data cuts can look very non-conforming.

Thanks in advance.

Jane

The documentation for the use of terminology files at:

http://www.opencdisc.org/configuring-opencdisc-validator-cdisc-controlled-terminology

refers to OpenCDISC v1.4 and shows examples of CT .txt files stored in Config/Data/CDISC/SDTM.  However, the actual installation of OpenCDISC Community 2.0 contains .odm.xml files in these locations.

(1) Does OpenCDISC Community require .odm.xml files, or can it also handle text files?