SDTM

Dear Team,

Could you let us know when will the P21 Community Version for SDTMIG v3.3 be released?

Thanks

Umaporn

Hi,

We got SD1339, "Missing EPOCH value, when a start or observation date is provided", firing in a DV domain where DVDTC is populated (date when the deviation was reported), but DVSTDTC/DVENDTC are missing (dates when the deviation occurred). Per SDTM-IG, EPOCH in DV is the "Epoch associated with the start date/time of the deviation". It should therefore not be tested against DVDTC.

Kind regards,
-- Thierry

We got SD2239 firing (different --TPT for the same --DTC) for SDTM-IG 3.2, FDA flavor. It references CG0240, but the latter is about one-to-one relationship between --TPTNUM and --TPT, and does not mention --DTC. Furthermore, since --TPT is a planned timepoint, so it makes no sense to compare it with an actual datetime. (You could have two samples drawn on the same date/time, but which were planned to be taken on different timepoints, for instance.) Apparently this is a PMDA rule, but it is present as FDA rule as well?

Hi all

I have FATESTCD='OCCUR' and FATEST='Occurrence' in my FA domain and this produces no Pinnacle 21 error, however when I run my Define.xml through Pinnacle it produces the following: 'FATESTCD/FATEST mismatch in Codelist 'FATESTCD'

The note on the rule says: 'When SDTM Event or Intervention qualifier variable is used as FATESTCD, then FATEST should be the corresponding qualifier variable label.'

Can some advise, what should FATESTCD/FATEST be for this, should SDTM change or just the Define, and if just Define what should change ?

Best

Colm

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.