SDTM

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

Hello:

May I ask whether the number of ARM in TA domain should be consistent with that of TS. NARMS?

Thank you in advance for your assistance,

Xiaowen.Wang

Pinnacle 21 ID is SD1337. This rule doesn't seem right, because the link between RS and TR is through --LNKGRP not LNKID, this is stated in RS assumption 5.

Hi!

I am wondering about the error when DM.ARMCD does not equal TA.ARMCD where ARMCD is not “SCRNFAIL” or “NOTASSIGN”.

Ad per SDTMIG it is possible to only populate part of the ARM in a trial with more than 2 branching points. In that case ARMCD would not match TA.ARMCD. See section “Subject is not assigned to an Arm” in the IG and DM/SE example 7.

Hello,

In Pinnacle 3.1.0 in the validation report for SDTM, we have received the message 'Negative value of ECSTDY Study Day variable' (for ECENDY as well). As you see, message related to the EC dataset although rule SD1135 states 'Study Day variables (*DY) value should not be negative in Exposure (EX) datasets.'. 

Good Morning,

When running SDTM datasets PC, PP and RELREC through Pinnacle 3.1.0 community version my team does not see any error's/warnings regarding the PPORRES in relation to PPSTRESC. However, clients using Pinnacle Enterprise are getting this error when running the same datasets: 

Unlike Meddra and WHO, Loinc codes are collected from lab and dictionary version would not be single one. Is it required to be kept in SDTM to be decoded?

Why Severity info is no longer available on the P21 community version?