SDTM

According to the FDA Rule v1.3, SD1306 : 

Business or Conformance Rule Validated = If the study population is healthy subjects (i.e., healthy subjects flag is Y), this parameter is not expected. If the healthy subject flag is N, then this parameter would contain the diagnosis/medical problem of the study population. [Validation rule; IF healthy volunteers = N then TDIGRP must be present and not null 

For example, some crf raw data Visit 1 start date less than some raw data Screening visit end date. In SV domain, this patient will have overlapped visit on screening and Visit 1. Similar example for 'Early Termnation' page visit date overlap with the last scheduled visit end date. Can we just leave the visits dates overlapped in SV domain and explained in SDRG?

Hi, Can I get an explanation regarding the TS00xx queries that are firing in the P21E version?  These look like new checks, right?  Or are they a rehash of other checks.

Thanks.

We collect PANSS data and we map to RS per CDISC implementation, however, it seems that Pinnacle 21 is expecting the RSTESTCD to come from the Oncology Response Assessment Test Code.  The latest CT has PANSS mapped to Clinical Classification Test Code, so regardless of what we do, this Warning will always fall out in P21.  Do you have a recommendation of how I can get rid of this warning from P21 or how should we explain this warning if we leave it as is?

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Please note that subject is LOST TO FOLLOW-UP (Withdrawn) , last contact date on 15Jan2019.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