SDTM

Hi,

A subject is randomised to treatment sequence ABC, the subject has withdrawn the study after taking first treatment(A).

What would be the value of ACTARMCD/ACTARM for this subject ?

Regards

Ashok

For one of my current studies, the derivation of the SDTM Baseline Flags was implemented before the derivation of analysis baseline was fully known. Therefore, the baseline flags do not always match between SDTM and ADaM.

In SDTM, we take the last nonmissing value prior to first dose. This could include unscheduled assessments.

In ADaM, we prioritise the scheduled Week 1 value as long as it is prior to first dose, otherwise if its not prior to first dose or its not available then the last nonmissing value prior to first dose is used.

Hello ,

I use Open cdisc Validator 1.5 and  when I run the SAS Macro to create my : open CDISC Validator support REPORT

I have some SKIP on file txt SDTM TERMINOLOGY.TXT in sheet Issue Summary

list of SKIP :

SKIP_CT0021    |   .... SDTM Terminology.txt is missing and  Lacks necessary variables and cannot be used for this cross  datasets validation

It appears to me that rules CT0178 and CT0179 have been reversed in the v1.5 OpenCDISC Validator SDTM v3.1.3 configuration file .  I've attached a file to show you better what I'm trying to explain.  In the first image, I have a screenshot of the quarterly SDTM terminology QS-FT file.  The code C102408, codelist codes: CT101815 & CT101816 refer to the "QS-Eastern Cooperative Oncology Group Performance Status" TEST CODE & TEST NAME respectively.  In the second screenshot, I show the OpenCDISC report, rule description tab, rules CT0178 and CT0179.

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).