SDTM

Hello, I have a question regarding the SDRG completion guideline.

There is a section called 'SDTM subject domains' and it is written that 'The section provides an overview of the subject-related SDTM domains'.

What do they really mean by 'subject-related domains' ?So not all of the domains created will be listed there?

Thanks!

Hi, I'm creating PP domain for the PK parameters calculated per study period, and I get SD1117 check from P21 report if I put the PERIOD information into PPGRPID.

I've tried to add it to PPCAT to avoid this error but it seems not a good solution because PPCAT should be populated the Analyte from PCTEST according to SDTMIG.

Is there any suggestion? Combing the PERIOD information with Analyte in PPCAT, like "Analyte: Period 1", is acceptable?

SDTMIG 3.3 (FDA).
In my RE datasets, I have measurements for which the same device was used. So, I have more than one measurement per unique device.
Although my values of RESEQ are unique for each measurement within each subject, I get a large numbers of errors SD005 "Duplicate value for RESEQ variable".
Example:
row 1: USUBJID=21, SPDEVID=DEV33, RESEQ=1
row 2: USUBJID=21, SPDEVID=DEV33, RESEQ=2

It looks as the software wants to have SPDEVID being unique within each subject, which has nothing to do with RESEQ.

Hello CDISC/FDA/PMDA Experts! 

Dear P21 community, I run for the latest P21 for the report. But the CT2002 is not work for my report.

Before I use version 3.1.2, the version 2.2.0 can find out the extensible codelist issues. See attachment:

Does anyone who has the similar experience for this?

My P21 settings:

Configuration: configs\2010.1\SDTM-IG 3.2 (FDA).xml (No changes for Active)

CDISC SDTM CT Version: 2019-09-27

Software Version: 3.1.2    

Best Wishes,

Hans

Hi, I have a question regarding multiple acrfs for one study (three-part study with two CRFs). What is the correct approach? Should two SDTM packages be created, or can there be only one with acrfs merge to one pdf for submission? Is it important whether the data has been collected into one or two initial databases? Thanks a lot in advance!

SD2282: Missing THERAREA Trial Summary Parameter. 'Therapeutic Area' (THERAREA) record must be populated in Trial Summary (TS) domain. It is an 'FDA Desired' parameter listed in the Technical Conformance Guide (TCG).

I got this message when I try to validate one of my TS domains, I thought the field of TSVAL when TSPARAMCD="THERAREA" is a free text field, yet it is not.

Hi everyone! My team is submitting a study which involves electroporation after vaccine injection. I would like to make a record of DX domain (Medical Device domain) and I am wondering which ROUTE terminology should I use for electroporation. I can not find any references and evidences on the Internet. Please help or share your opinion! Thank you!

I noticed an issue in TS and thought it was weird the Pinnacle didn't catch it. Looking again, Pinnacle did catch it, it just didn't list the issue (SD1268) in the Issue Summary tab like I had expected. The issue was listed in the Details tab only.

I am trying to validate a SDTM package that has SUPPSV dataset.

Although the SD0095 rule clearly says that you can use SUPPQUAL only for general-observation-class datasets (Events, Findings, Interventions) and Demographics, this rule was not fired in the validation report.

I am using  p21 community version 3.1.2, Validation Engine Version: 2010.1 

Can you help me determine the reason.