SDTM

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?

Why are some versions of MED-RT/NDF-RT not available in the Pinnacle 21 community?
For example, referring to the NCI archive, there are 10 MED-RT/NDF-RTs registered in 2018, but only 6 could be selected in the Pinnacle 21 community.
Is there a  regulatory or Pinnacle's technical reason for this?

Kind regards,
Takayuki

Hi,

I am working on an extension study with over 200 visits. Most of the visits contains the same assessments, just repeated over and over again. When bookmarking and creating TOC, do we have to create a bookmark for every visit? This would also make the TOC very, very long. Could we maybe use "Visits 100-150" as the bookmark label instead of having to do each one individually?

Thank you!

Courtney

Hi CDISC Experts!
I apologize if this question has been asked before. 
If subject enters study with ongoing Med History, takes study drug and after a couple of months Med History event ends. 
Do we map end of Med History event to MH.MHENDTC even though MH is collected only during Screening? Or there is another place where we can map end of, for example, seasonal allergies after subject started taking study drug. 
Thank you for taking your time! 

Hello:

Can TI. TIVERS be assigned multiple values if different versions of the I/E criteria are the same? Or should I create multiple records and specify the respective protocol versions in the TIVERS? e.g, TI.TIVERS="1.1, 1.2".

Thank you in advance for your assistance,

Xiaowen.Wang