Troubleshooting and Problems

Dear Pinnacle Team,

Thanks so much for the really useful tool. Quick question on the versioning between P21E and P21C. Is there any plan to update the statement of 'Compatibility with Enterprise'? I do not think that only P21C v2.1.3 is the compatible version of P21E v3.0.5.

Thanks!!
Taku

When running Pinnacle Tool I get the unexpected message SD0058  "Variable appears in dataset, but is not in SDTM model" for the FAOBJ variable. The dataset is called FACM, and other checks seem to run as expected for a FA domain. See attachment for extracts from the report. 

FAOBJ is a text variable. I am trying to find the root cause for this error? 

Thanks, Pernilla

Dear Pinnacle Team,

Thanks for the useful tool. We are using the CLI functionality which is very comfortable. The issue is that the old version number 2.1.2 is still shown, although we are using Version 2.2.0. Can you please check this?

In addition I would remain you that the define.XML check cannot be submitted per CLI functionality. Is it possible to support the define.XML check per CLI?

I'm currently trying to represent controlled terminology in the ValueLevel section for define.xml 2.0. The issue I'm seeing is in the WhereClauses tab of the Excel Spec the first column (ID) is being ignored and through the process within the Community tool it recreates this ID using the Value column. The problem with this occurred when I had an IN comparator and a value of DIABP, SYSBP for VSPOS and DIABP, PULSEPR, SYSBP for VSTRESU.

Hello,

After generating an SDTM 3.2 spec from XPT files, I proceeded to enter Origin as "CRF" and "Pages" as the page number 66 from the CRF. 

I only see "CRF Page" on the define.xml rendering, not the page itself, when I generate the define.xml from the spec.

With Predecessor on ADaM define.xml, the Predecessor isn't appearing on the define either.    

I'm using P21 Community 2.2.0 on Windows.

Any thoughts?

Thanks!

Larry Sleeper

I am having trouble validating TSVAL where TSPARMCD = PCLAS.  The pharmacologic class is "[BL116] ANTIHEMORRHAGICS" and the associated code is "N0000029112".  Both of these values receive an "ERROR" rating under SDTM 3.1.2.

I looked at your reference table for NDF-RT and it appears to be missing this record.  Could you give me some advice.  Should I add the records from the list (ftp://ftp1.nci.nih.gov/pub/cacore/EVS/NDF-RT/NDF-RT.txt) on NCI website?

Thanks for your help.

 

Hi -

I'm trying to follow the instructions from the link below - to add MedDRA. But the images in the link are broken so I'm not sure what exactly I should place in the MedDRA version folder under step 3. Can someone provide some advice? https://www.pinnacle21.net/projects/validator/configuring-opencdisc-validator-external-dictionaries

Hello,

When will the latest version of the SEND Controlled Terminology (2016-09-30) be added to the community version? As the SEND CT is updated quarterly, will the validator be updated soon after each release to include these?

Cheers. 

Following file is invalid. Please update the file

 Pinnacle 21 Community version 2.2.0
 SDTM Terminology.odm.xml for 2016-03-27

The content of the file is created from CDISC terminology of 2015-03-27 (please see the year. This is 2015 !). Furthermore, there is no SDTM terminology of 2016-03-27. The official release date is 2016-03-25.

I noticed you have a set of instructions for configuring MedDRA.  But how would we add LOINC?

The example for the UNII dictionary only shows two columns.  For LOINC it needs several variables whose values confer uniqueness to the row. For example, a row-uniqueness is usually determined by the combination of LOINC NUM, COMPONENT, PROPERTY, SYSTEM and METHOD.

Thanks

Joyce