c Craig




I have produced a define.xml and I am trying to pass it through Pinnacle 21 to validate it, but it fails. Note, the define.xml code was not produced using the pinnacle 21 process and is created using an external process.

Error code: 56 message: Failed core process.

Failed local validation process. 
standard=Input{value=StandardType{value=SDTM-IG 3.3 (FDA).xml, name=SDTM-IG 3.3 (FDA).xml}, userProvided=true, empty=false}, 
standardVersion=StringInput{value=, userProvided=false, empty=true}, 
meddraVersion=StringInput{value=, userProvided=false, empty=true}, 
sdtmCtVersion=StringInput{value=2021-03-26, userProvided=true, empty=false}, 
qrsCtVersion=StringInput{value=, userProvided=false, empty=true}, 
adamCtVersion=StringInput{value=, userProvided=false, empty=true}, 
sendCtVersion=StringInput{value=, userProvided=false, empty=true}, 
ndfrt=StringInput{value=, userProvided=false, empty=true}, 
unii=StringInput{value=, userProvided=false, empty=true}, 
whodrug=StringInput{value=, userProvided=false, empty=true}, 
snomed=StringInput{value=, userProvided=false, empty=true}, 
projectName=StringInput{value=, userProvided=false, empty=true}, 
studyName=StringInput{value=, userProvided=false, empty=true}, 
groupName=StringInput{value=, userProvided=false, empty=true}, 
dataPackageName=StringInput{value=, userProvided=false, empty=true}, 
reportSource=DataSourceInfo{dataSource=FileDS{path=P:\Pinnacle 21\Reports\pinnacle21-report-2021-10-08T10-29-14-963.xlsx, schema=FILE, cleanup=false, valid=false}, 
format=Input{value=EXCEL, userProvided=true, empty=false}, 
cutoff=1000, delimitedInfo=net.pinnacle21.oce.model.input.DelimitedInfo@278734a0, remoteDataSource=null}, 
source=FileDS{path=\\manchesterserv.macukneuroscience.local\Programming\Sandbox\cparry\Deliverable\Data\SDTM\define.xml, schema=FILE, cleanup=false, valid=true}, standardFilter=Input{value=FDA, userProvided=false, empty=false}, 
sourceFormatType=Input{value=DEFINE_XML, userProvided=false, empty=false}, 
sourceDelimiter=StringInput{value=,, userProvided=true, empty=false}, 
sourceQualifier=StringInput{value=", userProvided=true, empty=false}, 
define=FileDS{path=\\manchesterserv.macukneuroscience.local\Programming\Sandbox\cparry\Deliverable\Data\SDTM\define.xml, schema=FILE, cleanup=false, valid=true}, 
createAlways=Input{value=true, userProvided=false, empty=true}, 
engineVersion=Input{value=2010.1, userProvided=true, empty=false}, 
encoding=Input{value=null, userProvided=false, empty=true}, 
engineFolder=provided, downloadConfig=Input{value=true, userProvided=true, empty=false}}, 
config=ConfigInfo{configSource=FileDS{path=P:\Pinnacle 21\configs\2010.1\Define.xml (FDA).xml, schema=FILE, cleanup=false, valid=true}, standard=Define, version=unknown}, threadCount=3}
Unable to load validation service from module pinnacle21.validation:2010.1

I have attached the define in question.

Many thanks


Attached Files

Forums: Troubleshooting and Problems

j Jozef
on October 8, 2021

Hi Craig,
I validated your define.xml using another (professional) Define-XML Checker ;-).
If you want, I can send you the report (text file) by e-mail. It reports 507 errors with line numbers and everything
Major issues in a nutshell:
- empty "Length" attribute on a number of ItemDef elements
- "MethodOID" attribute missing on ItemRefs for ItemDefs with Origin="Derived"
- A number of CodeList elements is missing although a reference to them is provided
- CodeList "CL.MEDDRA" is not referenced e.g. from AEDECOD
- No def:Origin for a number of ItemDefs that are not ValueList ItemDefs
- Empty "DataType" attribute on all "CodeList" elements
I could also validate your file with P21 3.1.2 without problems, providing 330 errors without line numbers.
So, it looks as your P21 installation is broken...
A few questions back:
- do other define.xml files validate without the software breaking down?
- does it validate when you remove the xsi-schemaLocation="...." ?

c Craig
on October 11, 2021

Thanks Jozef for providing a response.

As a side note, I am running Pinnacle 21 community 3.1.2 via a remote desktop applet.

To your first question, yes oddly the define.xml validation worked fine when I used 4 domains only (DM, AE, EG and TS), but when I included the full study it seems to fail. Note, I am expecting comments from the P21 report but I just wanted to process to produce the report, which it fails to do.

To your second question I did not try this, oddly this morning the process ran without issue, which confused me because the define had not changed.

on October 11, 2021

Hello Craig,

Thank you for reporting this error.

According to this message, there was an issue with loading engines from the config folder on your remote drive (P:\Pinnacle 21\configs):
"Unable to load validation service from module pinnacle21.validation:2010.1"

This is not related to the define.xml itself, it was most likely caused by an interrupted Internet connection or slow network drive response. 
Is there any firewall or firewalled VPN in your environment that could prevent Community from reaching its config folder?



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