SDTM

Hi!

I have a case where this check pops up only when generating the cdisc report together with the define.xml. However, when using only the SDTM datasets, this check does not appear. Is anyone able to explain why this is so?

Thanks!

Hi,

According to the IG 3.1.3 (section 7.6) or IG 3.2 (section 7.4), Example 2 shows an example of how to implement the null lfavor in TSVALNF when the value in TSVAL is missing. In this case, TSVCDREF should be assigned to "ISO 21090".

In my SDTM.TS dataset, some records are populated as follow : TSVAL and TSVALCD are null, TSVALNF is filled in with null flavor values (ie NA, UNK) and TSVCDREF = ISO 21090 for TSPARMCD = INDIC, PCLAS, REGID, TINDTP, TRT.

Hi,

I just use the latest community 2.1 to validate SDTM datasets (3.1.2). However, I found four wield hits which doesn't seem correct. The report output four label mismatch for AESEV and LBSTNRC, but I double checked and compare with the previous report. I think it might be a false alarm. Please share your thoughts.

AESEV, Severity/Intensity

LBSTNRC, Reference Range for Char Rslt-Std Units

TAETORD, Order of Element within Arm

IETESTCD, Incl/Excl Criterion Short Name

I am validating on SDTM 3.2, where PCSTRESC label is Character Result/Finding in Standard Format, however when i create xpt's the label is truncated to 40 char, So OpenCDISC gives a warning, Is there a solution to this? There are many labels in SDTM IG 3.2 where variable labels are more then 40 Chars. 

Please do let me know your thoughts.

Thank you.

These rules seem to be firing for the trial phase codelist due to letter case mismatches.  The relevant Pinnacle codelist metadata (OID = "CL.C66737.TPHASE" and OID = "CL.C66737.TPHASE.CD") appears to have all of the values upcased, but the CDISC published terminology for codelist C66737 has mostly mixed case values.

Hi

I am using Open CDISC Validator 2.01 with CDISC CT Version: 2015-06-26 and it is giving a Warning when the units  for PCORRESU or PCSTRESU are ng/mL. Not sure the reason for getting this Warning eventhough ng/mL is CDISC submission value for PK Units of Measure. Any clue for this Warning?

Thanks for your help in advance!

Srim

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.