When things just don't seem to work
I get this incorrect warning with Pinnacle21 Community 2.1.1 Validator for my EX domain. I've confirmed the order of the variables matches the SEND IG 3.0.
VARIABLE, DATASET
EXMETHOD, EX
SD1079
FDAN035
Variable is in wrong order within domain
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Hi
I am using Open CDSIC validator 1.5.
I am getting the following notice 'D:\OpenCDISC\opencdisc-validator\config/data/CDISC/SDTM/2015-12-18/SDTM Terminology.txt is missing or lacks necessary variables and cannot be used for this cross-dataset validation'
Please give me the solution.
We are getting these errors in the P21 report for a study. The issue is “Pharmacological Class” for Levofloxacin. We used “Fluoroquinolones” with a code of N0000011190. However, P21 says it is not found in NDF-RT.
Looking in the configuration file supplied with v 2.1.1 I cannot find this reference in there. But it is present when I download the entire text file. I know that I can replace with an updated txt file but will this same error occur with the FDA Enterprise version when we submit?
Thanks
Dave Borbas
I was having trouble with this check, but have been able to clear most of the issues now. The TI and IE are giving me messages, but I understand why and can figure out the best fix. However, when I ran the SDTM example through Pinnacle 21 this check came up for the TS domain. Other checks come up too, I think the example define.xml should be clean for users.
Hi,
When validating a define.xml, false positives have appeared:
DEFINE DD0031: 1 Error - Missing NCI Code for Codelist 'Null Flavors'
count: 1 | | Missing NCI Code for Codelist 'Null Flavors' (Error)
DEFINE DD0032: 2 Errors - Missing NCI Code for Term in Codelist 'Null Flavors'
count: 1 | CodedValue = NA | Missing NCI Code for Term in Codelist 'Null Flavors' (Error)
count: 1 | CodedValue = PINF | Missing NCI Code for Term in Codelist 'Null Flavors' (Error)
The CT2004 ERROR message (TSVALCD value not found in 'No Yes Response' non-extensible codelist when TSPARMCD == 'RANDOM') is displayed when I use new Pinnacle 21 v 2.1.1 release, however it seems that my TS domain data is not wrong (regardless of C49488=Y or C49487=N). This issue is found in othe companies. Could you please check it?
we encountered the below issue when we tried to modify the CT text file for version 1.5 of opencdisc in windows but the same file when we use in our linux servers we have no issues in validating our custom CT. we even checked for special characters and all seem to match. yet we get the below issues.
we encountered the below issue when we tried to modify the CT text file for version 1.5 of opencdisc in windows but the same file when we use in our linux servers we have no issues in validating our custom CT. we even checked for special characters and all seem to match. yet we get the below issues.