SDTM

I'm getting errors in SQAPMH.
SD0058: Variable appears in dataset, but is not in SDTM model
SD0057: SDTM Expected variable USUBJID not found

Class seems to be recognized as a RELATIONSHIP, but what validation rules are being applied ?
(Are the current validation rules the same as the general SUPPxx??)

We have Pinnacle 21 Community 3.1.2.
This errors are the same for both PMDA (1810.3) and FDA (2010.1) Engines.

We have Pinnacle 21 Community (currently version 3.1.2) installed on a Windows server.

How do we set up to ensure that MedDRA dictionary versions are available for all users without them having to individually install every version and what is the recommended process when a new dictionary version is available?

I have tried changing the Configs and Terminology folder location under Preferences to point to the folder containing the dictionaries but this has no effect.  

Hi, this is MinJi.

In large subjects study (e.g. phase 3), there are some cases in which blank rows in AE/MH/CM eCRF DB were collected.

In this case,  to remove validation findings, can the sponsor delete null MHTERM/AETERM/CMTRT data?

Thank you for your help!

Best regards,

MinJi

In the SDTM.EC, we have some records with ECTRT = PLACEBO, and ECDOSE = 0 and ECOCCUR = Y, the issue SD1247 was occurred. We are wondering for these records with ECTRT = PLACEBO and ECDOSE = 0, should we manually update ECOCCUR into N after unblinded? Or could we explain this issue?

Hi,

In PINNACLE21Enterprise, I know "P21 2010.1" Engine is useful to varidate PMDA check and FDA check simultaneously; however, in PINNACLE21 training in Japan, the trainer recommended not to use "P21 2010.1" for PMDA submission (i.e. P21E should be run with FDA Engine and PMDA Engine separately)  because some PMDA specific checks can't be fired.

Has it been resolved ?

Thanks.

Hi team,

We have successful enrollment of a participant in a trial under different ARMCD due to multiple protocol amendments. Subject was randomized first under Placebo and successfully completed protocol required procedures. Later study had become open-label and subject has been enrolled into Active drug ARM. As per FDA technical conformance guide, 

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