SDTM

Hi,

I have some confusion about the SDTM version submission to FDA. For now, the latest version of SDTM is v1.4 and IG is 3.2( with AP v1.0 and MD v1.0). However, FDA, so far, only accept SDTM v1.3 (IG 3.1.3). Since we don't have the date for acceptancy of SDTM v1.4, then on what reason we can still use the SDTM v1.4?  

Or new domains in the SDTM v1.4 can be treated as custom domain when submitted to FDA? What about AP-- domain, or new variables ?

Thanks in advanced!

Hi!

On purpose I found out that I have a case where AESTDTC is before Informed Consent was signed. This study is a legacy study, so the DB is closed since 8 years.

The rule SD1204 (AEENDTC after RFPENDTC) exists, but for the case above there is no warning/error. Is that correct?

Thanks!

Dears,

I have a question while creating and vallidating SDTM TU and TR domain.

For example, I have screening tumor data for three target lesions at liver site SEGMENT 3, SEGMENT 4 and SEGMENT 7. Also, the corresponding three Longest Diameters are recorded.

Thereafore, I should create three rows on TU and TR domains for liver site SEGMENT 3, SEGMENT 4 and SEGMENT 7.

For TR domain, the TRTEST='Longest Diameter'/TRTESTCD='LDIAM' for TRLNKID 'T1', 'T2', 'T3';  

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