SDTM

I am puzzled about the FDA rule "SE0009 - Missing values for both --DTC and --DY variables".
According to the Excel worksheet published by the FDA, the rule applies to both SDTM and SEND, but it does not seem to be listed in Pinnacle21 SDTM validation reports.
Was this forgotten or is there an error in the FDA Excel and is it only applicable to SEND?

Rule SD2237 states "ACTARM does not equal ARM", and "A value for an Actual Arm (ACTARM) variable is expected to be equal to a value of an Arm (ARM) variable",
but the FDA technical conformance Guide March 2019 states:
"For subjects who are randomized in treatment group but not treated, the planned arm variables (ARM and ARMCD) should be populated, but actual treatment arm variables (ACTARM and ACTARMCD) should be left blank".

I am using the variable MITSTDTL (Microscopic Examination Detail) to indicate differences between STAINING INTENSITY and STAINING EXTENSIVENESS. However, this variable is not included when evaluating for duplicate records in Pinnacle and therefore warning messages are generating. Should MITSTDTL not to included here?

Why is pinnacle generating an error message for MH events that start before rfstdtc, but have an endtc during the study? This doesnt make sense to me since ongoing  is acceptable. 

Hi,

It is sometimes convenient, as a contractor, to run checks quickly for SDTM datasets with the new Community 3_0 without running in Enterprise, which requires creating project and study setup.  I expect the rules to be roughly consistent with Enterprise, if I'm using new Community version 3.0.

Hi Team,

Can you please provide an example for Difference in RFSTDTC and RFXSTDTC variables? Are both the variables same i.e first study drug exposure date? If not, in what situation will the dates differ?

I am working with a protocol that includes survival follow-up conducted via phone calls or review of medical records.  We are struggling with how to approach the survival follow-up reviews which identified the subject to be deceased. At the moment we have:

When we place the June-2017 CT (SDTM Terminology 2017-06-30.odm.xml) in the config folder (\\components\lib\configs\data\CDISC\SDTM) of Pinnacle Community version, Its is not displaying the CT and we cannot use them for MDR sourced define.xml file.

We find old CTs are not compatible with Pinnacle Community 3.0.0 in the below url,

https://www.pinnacle21.com/downloads/cdisc-terminology

Hello, I really enjoy looking through the config files to see what the warnings and error messages are expecting.  In the new version 3.0 of the software they are located in an odd location and don't pull up correctly as an xml file.

Current 3.0 location: P21_FOLDER\resources\app.asar.unpacked\components\lib\configs\1903.1

Hello,

Is there a time schedule to when Pinnacle21 plans to support SDTM IG 3.3 validation?

Thank you!