SDTM

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.   

Hi guys,

In the 2.2.0 version of Pinnacle, xml's with SDTMIG metadata can be found in  the directory <_220\components\config>. For the 3.2 version, we imported this data in SAS and consequently created a SAS dataset including all domains and their metadata.

We would also like to do this for SDTMIG 3.3. In the latest Pinnacle version (3.1.2), there is an xml file called 'SDTM-IG 3.3 (FDA)' in <configs\2010.1>. However, the CT codes are not included.

Hello,

I am now working on a study where subjects were randomized to use drug A or drug B.

There is not an example in SDTM IG 3.3 what exactly does LBSTREFC should be populated with apart from its label - Reference Result in Standard Format. We already have variables - LBSTRESC & LBSTRESN - Captures values in standard format, along with LBSTNRLO, LBSTNRHI, LBSTNRC - Reference Range values in standard formats. Does LBSTREFC value be copied from LBSTRESC ? If so, then What exactly is purpose of this 'new' expected variable?