SDTM

Hi,

While creating Trial summary domain where Study design involves phase 1 and phase 2, not sure how to populate the values for PLANSUB because for phase1  Planned Sample size is :Approximately 4 to 15 eligible subjects will be enrolled and  for the Phase 2 portion of the study, a total of 100 subjects will be randomized.I am thinking of only way is to use null flavor ,however no detailed  info for reviewer if we use null flavor.

Let me know if anyone has idea how to tackle this situation.

Thanks in advance.

Dear Team,

Could you please check the attached pic , i have taken from  Open CDISC report number (Open CDISC no-SD0042)  and let suggest on __STAT concept as looks like something different meaning as compare to MESSAGE to DESCRIPTION. Thank You!

Regards,

Milo

 

Hi!

The SD0006 check says that "All subjects should have at least one baseline observation (--BLFL = 'Y') in EG, LB, QS, and VS domains, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN')". However, what if lbtests are "NOT DONE". Here I do not see to set a baseline flag. Is this check then obsolete?

 

Thanks!

Dear all,

I would like to know if EXDUR can be used for instances where the IMP is applied via a patch test method to the skin of a subject and removed again, for example, after 2 days to assess some scores. The IMP is given once, however, the patch is removed 2 days later. So my EXSTDTC and EXENDTC are basically the same (because the IMP is given only once and not twice) , however, the IMP duration is 2 days.

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?