SDTM

Hi,

I have some question about multiple enrollments and multiple screenings.

In 2014, PhUSE WG suggested to update the structure of DM to "One records per SUBJID". However, the FDA and CDISC did not adopt this recommendation and insist that the structure of DM should be maintained as "One records per USUBJID".
So, I want to know the reason why the DM data set must satisfy "One records per USUBJID". How will this help the review process?

Kind Regards,

Marnie

The message for SD1358 is confusing.  It currently reads:  "ACTARMCD/ACTARM are populated but ARMNRS is not populated".  I think it should read something like:  "When ACTARMCD/ACTARM are NOT populated,  ARMNRS must be populated".

Hi,

Currently we notice that in EC domain when ECMOOD=SCHEDULED the timing variables ECSTDTC and ECENDTC are blank. As per SDTM IG when ECMOOD is scheduled both ECPRESP and ECOCCUR variables are null. As per recent pinnacle report this below rule triggered when ECOCCUR is null records. How are we going to handle in this case?

Hi, I have a question about SDTM in a clinical study divided into part.

For example, clinical study includes part1 and part2. And, CSR is made per part.

Therefore, SDTM will be created for each part. Then, is it ok if STUDYID is assigned the same?

Thank you in advance!

Best regards,

MinJi 

Hi, I have a question a case where protocol version and content are different.

In TS domain, the protocol contents differs according to the protocol version and the protocols are applied to the clinical trial.

If so. does the TS domain have to contain all protocol contents or just last version?

Thank you in advance!

Best regards,

MinJi

If we have a study that includes sub studies - then creating multiple NARMS in the Trial Summary might be convenient. However, the P21 throws an error that only one record of TSPARMCD = NARMS is possible. Should this be updated or do we need to include all sub-study arms into one record?

Hi,

We use a constant number (e.g. 99) for all unscheduled visits. The problem is when a subject has two unscheduled visits, those will be listed as separate rows in SV and check SD1060 (Duplicate VISITNUM) fires. Due to my understanding of SDTM it is allowed to have several unscheduled visits listed in SV for one subject.

CDISC SDTM IG 3.3, 4.4.5 Clinical Encounters and Visits

Hi Team!

Could you please explain the next confusing validation?

We have a patient who did not meet inclusion criteria but was randomized mistakenly, and we will treat the patient as "Screening Failure".

I understood that ARM variable in SDTM should consist of planned arm (assigned to through randomization).

For this case of SF patients who proceeded randomization mistakenly, which data (treatment group randomized vs. 'Screen Failure' vs. blank) should be filled in ARM variable?

Please consider that this case is not same with the case of patients who are randomized in treatment group but not treated.

Hi, I have a question about unit conversion from LBORRESU to LBSTRESU.

For example, CK-MB sample has original unit as U/L, but SI unit is μg/L.

I cannot find unit conversion rule from U/L to μg/L.

Therefore, we set LBSTRESU as 'μg/L.' and let LBSTRESC, LBSTRESN, LBSTNRHI, and LBSTNRLO values as null.

Could you please suggest any other idea?