SDTM

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 ?

I'm working on TS domain for study. I see confusing guidance from CDISC definitions for ACTSUB and SSTDTC

SSTDTC: The earliest date of informed consent among any subject (Date/Time of Informed Consent, RFICDTC) that enrolled in the study. For studies conducted without informed consent (ie. emergency use) use the date of treatment. Dates for subjects who were screen failures are not included.

ACTSUB: Actual number of subjects enrolled; may include subjects who were not randomized.

In your blog about new features for SEND validation rules you state that

Does the Pinnacle 21 use the Codetable Mapping Files issued by CDISC? If not, do you have any plan to use them in future?
Yes, we do check data at the value-level and so we use codetables that are similar to CDISC.

Is that also the case for SDTM and if so which rule applies CT2005?

Hello,

The rule SD1331 is absent in the last FDA Validator Rules 1.3 Release. However it present as in P21 Community as well as in Enterprise version of Pinnacle 21, as well as here on this web site.

Could anyone explain the situation please.

Thank you in advance.

Serhii