SDTM

Description

Technical support questions about SDTM standard and validation rules

Warning message SD1278 when TSPARAMCD="TCNTRL", TSVAL="NONE", TSVALCD=C41132 with SDTM CT: 2020-06-26

September 8, 2020
Forums

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)

SD2265: TSVAL/TSVALCD value mismatch for PCLAS for "Immunoconjugates"

September 1, 2020
Forums

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

VALIDATION: --TERM / --DECOD

August 24, 2020
Forums

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!

ACTSUB and SSTDTC

July 9, 2020
Forums

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.

CodeTable Mapping implemented in SDTM validation rules?

July 9, 2020
Forums

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?