SDTM

Hello,

When running the validator 2.0.1 the OpenCDISC rule SD0063 gives the error SDTM/dataset variable label mismatch in IE and QS (QSSTRESC, Character Result/Finding in Std Format) and (IETESTCD, Incl/Excl Criterion Short Name) when data shows;

Character Result/Finding in Std Format

Inclusion/Exclusion Criterion Short Name

when SDTM IG 3.1.3 request for

Hello,

Column G on the Details tab and Column B on the Rules tab lists "Publisher ID" numbers all of which begin with FDA.  Do these correspond to something the FDA published?  I couldn't find any information about what these numbers represent.

Thanks!

Hi ,

I have created my file SDTM Terminolgy.txt to run the custom opencdisc_validator1.5

When I create my file with SAS i have some Skip value and i don't understand (may be because of double quote or simple quote in value ).

the structure of my file is

code/ codelist code/ codelist Extensible (yes/no)/ codelist name/ CDISC Submission Value/ CDISC Synonym/  CDISC Definition/ NCI Preffered Term

the file must to respect this structure ? could you put value not filled for CDISC Synonym or CDISC Definition or NCI Preffered Term.

I'm confused by the way the codelist C66742 is represented in the v2.01 "SDTM 3.1.3 (FDA).xml" file.  There are 79 occurances of the tag <CodeListRef CodeListOID="CL.C66742.Y"/> in the file.  I would have assumed the tag would be identified by the codelist name value of "NY" instead of "Y".  Is this a mistype in the file OR a method that OpenCDISC Validator uses to subset codelist (in these cases only "Y" values are valid)? OR something else?

Thanks!

Hi!

I have a question regarding the DSDTC and DSSTDTC for Disposition Event Treatment for example. If a treatment starts on day 1 and ends on Day 10, what exactly is my DSDTC and DSSTDTC. The DSSTDTC would be my first treatment date (day 1) and my DSDTC (Date of Collection) would be the last treatment day / Or withdrawal day?. If so, then DSDTC is after DSSTDTC. Would the validator give me an error in that case?

Thanks for your help in advance!

This message posted by Travis on behalf of Kumar Komuralli:

Can someone help me to understand more about the differences between SDTM and SDTM Plus?  Why do some companies use SDMT Plus instead of just SDTM.  Starting jan 1st 2017 as we all know datasets need to be submitted to FDA in SDTM format so what is the plan for those companies who use SDMT plus?  does FDA accespt this?  Please share your thoughts/ knowledge about this.

thansk, Kumar

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.