SDTM

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?

Why is there still a check for the AETRTEM flag in SUPPAE when there is no longer a mention of this variable in the FDA Study Data Technical Conformance Guide?

Thanks.

Hi

I am not sure why this issue fires if all looks okay for PCLAS where TSVAL = POTASSIUM CHLORIDE, TSVALCD = N0000145835. As per NDF-RT all is okay. The version is 2018-02-05 Any ideas? I have seen similar issues for values that are uppercase especially.

Pinnacle 21 Community Validator raises a rule SD0072 error "Related Domain Abbreviation (RDOMAIN) must have a valid value of Domains included in the study data".  

I am following the Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review use of FACE as a domain. I am also following the SDTM Vaccine TAUG v1.1, which explicitly provides an example where RDOMAIN='FACE'. A dataset face.xpt exists with DOMAIN='FACE'.

Is there anything I can do to avoid the SD0072 error and still comply with the OVRR and Vaccine TAUG guidance?