Troubleshooting and Problems

I recently ran OpenCDISC validator on XPT datasets from one of the study I am working on.

The validator ran fine. When I tried to open the report, I got this message 'Excel found un-readable

content in the OpenCDISC report. Do you want to recoved the contents?...,click Yes '. When I clicked

Yes, Excel was able to recover the file. When I looked into this report, there were error messages

which we not true and not applicable to the data. For ex - One of the error message says 'NULL value

OpenCDISC Community Edition Validator crashes when validating SDTM datasets in Dataset-XML without (optional) define.xml.

Error message is:

I am using OC 2.0 from the command line, and wanted to specify the version of the SNOMED, UNII and NDF-RT.

Hi,

I am validating a submission with OC 2.0. The submission uses SDTMIG 3.1.3 & Define 2.0. I get a series of messages about invalid TSVAL/TSVALCD values, that are wrong:

First type of message:

CT2004/FDAC343 TSVALCD value not found in 'Intervention Type' non-extensible codelist

Dear all,

I met one issue to open OpenCDISC community application, after double click “opencdisc-community.exe”, the window is blank, the application can not be shown successfully.

Duplicates in the ouput? The output has 2 records are identical except that on is listed as a Warning and the other is an Error.

 

 

1 AESEQ, USUBJID 1, 10011001 SD1097 FDAC022 No Treatment Emergent info for Adverse Event Presence Warning

I get error OD0075 (Invalid 'DataType' value) when validating a define.xml version 2 file containing DataType="durationDatetime", while this is one of the values listed in the specification (section 4.2.1. Data Type Considerations, page 21). I am aware that in section 5.3.11 (ItemDef Element, page 75), under "allowable values", we find the text:

Allowable Values: Refer to Section 4.2.1 for a list of the valid Define-XML DataType values.
Samples: For SDTM, SEND and ADaM variables one of (“text”, “float”, ”integer”, “date”, “datetime”).

Hi, Variables of config.xml does not work? Variabls means parameter between "%"(e.g. %Domain%). I found the problem, when I faced SKIP_SD0008: Message is "c:\opencdisc-community\components\config/data/MedDRA/%Variable.CodeList.Version|System.MedDRA.Version%/pt.asc is missing or lacks necessary variables and cannot be used for this cross-dataset validation". (Making unnecessary addition, path delimiters are "\" and "/".) Using OCC v2.0, I confirm wheather Variables work or not. Following is process of repeating problem.

Hi,

I tried to deactivate some of the rules running in the SDTM validator. My guess was that it was as easy as modifying the xml file (in my case the SDTM 3.1.2 (FDA).xml file), but this didn't work, at least not in the way I did it.

I just simply switched the rules that I wanted to be switched off to Active="No":

For example:

<val:ValidationRuleRef RuleID="CT2002" Active="No"/>

But when I run the validator after this, using this file, the rules I switched off still appear in the report.

Hi,

We have installed OpenCDISC Community, version 2.0.0, on a server on the C drive, and on this drive the write permissions are restricted to most users. But by default the report output location is in the 'reports' folder on the drive where OpenCDISC is installed.

Because of this we are forced to use the command line option to run OpenCDISC, because this enables us to change the default report location.