SDTM

Good day,

I would like to enquire as to when validation rules for the SDTM IG v3.3 standard will be available in P21 Community? With FDA support starting in March 2021, the need to validate fully against this IG would increase in the coming months. Thank you!

Regards,

Daniel

Hi,

We are using the clients P21E to validate our SDTM datasets. Our QA team is requesting that we delete the SDTM dataset after we run P21E report so that the client will not have access to the prevalidated SDTM dataset and instead wait for the official SDTM package that we will deliver. Is this possible in P21E?  Can the client access the actual SDTM datasets if we dont do anything after running the report?

Hi,

Raw float results in a study are sometimes entered has .5 instead of 0.5, for example, in EDC. Why Pinnacle is giving an issue for that? Is it because Pinnacle is expecting to see 0.5? I though --ORRES variable should contains original raw result. 

FDAC165 Unexpected MedDRA coding in the SUPPQUAL domain error is coming out in regards to QNAM=SVREASOC. REASOC is a variable that is mentioned for use in SUPP throughout the SDTM guide. Why is this error coming out?

Hi,

I'm get a warning message SD1278 from Pinnacle 21 report: "Inconsistent value for TSVALCD within TSVAL when TSPARMCD = TCNTRL, TSVAL = NONE and TSVALCD = C41132."

I only have a record for the TSPARMCD = TCNTRL. 

I checked CT for TSVAL = NONE that was document with Code = C41132 and Codelist Name = Control Type Response.

Not sure why I got this message and how to resolve it.

(SDTMIG : 3.2, SDTM CT: 2020-06-26, Pinnacle 21 version:  3.0.2)

I have P21 Community version 3.0.2 installed on a PC.

When I try to install MedDRA using the GUI, the version is set to 18.1 and grayed out. I want to install version MedDRA 21.0. How do I do this? Thanks for help on this.

Hi Team,

I am wondering why this check fires in P21E for PCLAS = Immunoconjugates. It is present in NDF-RT version 2018-02-05, but not in MED-RT. However, we can still use the NDF-RT I suppose? The description  of this issue also indicates that we can use NDF-RT or MED-RT: TSVAL and TSVALCD values must be populated from the same record in MED-RT or NDF-RT (Note: Any version 2018-02-05 or earlier uses NDF-RT, and any version after is MED-RT).

Thanks in advance!

Manolya

Is there a compliance check that ensures the same --TERM value is mapped to the same coded value in --DECOD?  I did see there were checks for --PTCD and --DECOD, but nothing I could find in the Validation Rules for --TERM / --DECOD relationship.  I know it seems obvious that the same value should be coded to the same decoded value, which I was surprised that was not a check.

Thanks in advance for any input!

Dear P21,

unfortunately, the 2020-06-26 update of controlled terminologies for P21 2.2.0 & 2.1.3 seem not to be available to download yet.

Could you please give an estimate until when those will be available ?

Many thanks,
Stefan

Hi,

I do not understand this issue. 

In the corresponding dataset, EXVAMTU is populated only both EXVAMT and EXTRT are filled in.

The error talks about EXTRTV, this variable was part of SDTM 3.1.3 and removed in SDTM 3.2.

Could you please clarify ? How can I explain this error in the csdrg ?