SDTM

1.According to NDF-RT we tried below and all three were failed. How could we get over the error:

N0000029636     [IM109] VACCINES/TOXOIDS, OTHER

N0000170916     Vaccines, Inactivated   [Chemical/Ingredient]

N0000011210     Vaccines    [Chemical/Ingredient]

2. some discussion mentioned https://rxnav.nlm.nih.gov/NdfrtAPIREST.html

the link shows as below - what info below can help?

Hi Team,

Can you please confirm what should be NCI codelist used for Country variable (COUNTRY, Country, C66786)? We have assigned it as C66786 as per NCI codelist available.However We keep getting this error while validating in Pinnacle Community version.

Hi Team,

Is there any way not to let P21 generate the define.xml for domains which has 0 records in .xpt files? 

Hi Team,

Why do we have P21 validator throwing WARNINGS for the values added as extensible codelist ? Can these be ignored if the extensible values are added to the codelist? I can see the values in define with an asterix however still getting such Warning messages.

Below FDA validator rule is not implemented in the P21 tool. May I know the consideration behind?

FDA validator rule ID SD1148 - Start Date/Time of Treatment (EXSTDTC) variable value must be greater than or equal to Date/Time of Experimental Start Date (EXPSTDTC) in Trial Summary (TS) domain.

Dear all,

Validating the TS domain we get the following WARNING if the TSPARMCD  EXTTIND, SDTIGVER or SDTMVER is missing: Missing …… Trial Summary Parameter
which can not be found in the Validation Rules here at P21.

Hi,

Is there any plan to release September CT for Pinnacle version 2.2.0 & 2.1.3? The latest available CT for the download is June CT;2019-06-08

Thanks,

Ravish

Hi Team,

While trying to validate SDTM datasets along with define.xml using Pinnacle 21 Community version, why do we get the Error message as Value for SCTESTCD not found in (Causality) user-defined codelist even if the values are added to the Codelist tab in the metadata and define? This message is appearing for multiple scenarios.Is there any specific information that needs to be updated in the Pinnacle 21 metadata spec to avoid this error?

Based on section 4.1.5.3.2 of SDTM Ig, if the variable value is greater than 200 characters, we place the first 200 characters in standard domain and rest in supplemental qualifier domain. The QNAM will have prefix 1,2 ... but the QLABEL stays the same. The example given also has QLABEL same for MHTERM1 and MHTERM2. However the Pinnacle gives the warning  "Inconsistent value for QNAM within QLABEL"

We have recently mapped Pharmacogenomic data to PF domain, when validating the data we get error SD0058: Variable appears in dataset, but is not in SDTM model, although, the variables PFGENTYP and PFGENRI are part of PF according to CDISC implementation guide for Pharmacogenomics and Pharmacogenetics.