SDTM

Hello everyone; 

I use Open Cdisc to validate my SDTM. My files are in SAS XPORT format (E.g: DM.XPORT). I tried many times to validate it with Open CDISC and received this error message "Invalide Source Format".

Any suggestions for me?

Thanks in advance!

MD, Biostatistician

 

 

 

When I use --LNKID, is it wrong that there is no --LNKID value which is the same value to it in the other domain ?

However, if there is a relevance to the variables(ie --GRPID) in the other domain, can I use --LNKID ?

Hi all,

If I have a Run-In Period in a study (where only Placebo was given), do we need to list this information also in EX? In the SDTMIG it says that IMP belong into EX. There is no such example for Run-In / Washout Periods. Placebo is not a real IMP, so not sure how to handle this. Some say, it should not be listed, others say, it should. Do you have any experience in this?

Thanks for your help in advance!

How do we handle data that does not fit the current terminology for a codelist that can not be extended?

I currently have and AE Action response as:

AEACN = “DOSE ADJUSTED” 

HI, We have TSPARMCD=’PCLAS’ and TSVAL=’Interleukin-17A-directed Antibody’ I am getting ERROR SD2263: Invalid TSVAL value for PCLAS I am checking this by using Opencdisc V2.0.2

EPOCH value as “TREATMENT PERIOD 1” in extensible codelist But still I am getting warning “EPOCH value not found in 'Epoch' extensible codelist” Please suggest solution?

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';