SDTM

Hi,

Does anyone knows where P21 v3.0 will install the MedDRA/SNOMED config files once we added the dictonaries? I knew v2.2.0 will have all config files under following location: \OpenCDISC\2.2.0\components\config\data but, I couldn't able to find with newer version(v3.0).

Thanks

Raju

Hi,

We are getting errors for Pinnacle21 rules SD2263/ SD2264/ SD2265 stating Invalid TSVAL and TSVALCD values and mismatch for PCLAS for the following values of these.  Can anyone help resolve this?  

TSVAL = Cancer Vaccines (Chemical/Ingredient)

TSVALCD = N0000170874

TSVCDREF = NDF-RT

TSVCDVER = 2016-09-08

NDF-RT  = 2016-09-08

Hi,

In case if VSDTC (15Jan2019) is exactly equal to SEENDTC of TREATMENT EPOCH. Should the EPOCH in VS domain be derived as TREATMENT or should it be NULL.

Please note that subject is LOST TO FOLLOW-UP (Withdrawn) , last contact date on 15Jan2019. Hence Treatment EPOCH record is last record of that subject .

Hi,

Why do we get warnings on in Pinnacle report the variable label mismatch?

ECPRESP, Pre-Specified

PESTRESC, Character Result/Finding in Std Format

What should be the Label ?

In a TB study, Quantiferon Gold plus TB test is being used for assessment. I'd like to know which LBTESTCD to be used for the same. While doing some research on the web, I came across a CT Request sheet where CDISC has recommended the sponsor to use 'MYTBGIR' (M. tuberculosis IFN Gamma Response), whereas in TAUG-TB ver 2.0, in an example for the specific test, LBTESTCD is given as INFG.

In my opinion, IFNG is more generic when compared to MYTBGIR. Any thoughts/inputs appreciated.

We have a situation in the study we are working on and would like to get pointers as to how to go about it.

We are creating SDTM datasets for a study where the mothers get enrolled in the second/third trimester of their pregnancy and the babies get the investigational product after birth. Here, the babies get the same SUBJID as the mother. In case of multiple births, one baby will get the mother's SUBJID and the other babies will be assigned new SUBJIDs (and these babies will have the same mother screening number)

Hi,

We have a CRF which captures information if Vomitting or DIARRHOEA has occurred since last visit . This question is asked at every visit (Visit 2-Visit 6).

Hi,

Can anyone advise which SDTM domain should we map Breastfeeding data?

Thanks,

Priyanka 

I have uploaded my SDTMs to P21 and created the define file.      In the SDTM issues I am getting a warning that VSTESTCD value not found in Vital signs Text Code extensible codelist.    When I go to the terms in my define, the term is listed.

Why is P21 giving me this message?

I have uploaded my SDTMs to P21 and created the define file.      In the SDTM issues I am getting a warning that VSTESTCD value not found in Vital signs Text Code extensible codelist.   

Here is what it lists: