Define.xml

Hi,

I created a Define.xml using an OpenCDISC Validator. If there are any new domains like SG(Surgery),ML(Meals) etc. which are not in SDTMIG 3.1.2 and OpenCDISC's config file(config 3.1.2.xml) then how OpenCDISC Validator will classify them as Events or Interventions or Findings or Observations etc...

Thank You,

Ashok

Hi,

I created Define.xml through OpenCDISC Validator. To get the values of RoleCodeList(Identifier,Toic,Grouping Qualifier etc.) in the define.xml should i include it in the Codelist in .xls format given by OpenCDISC which will be imported into OpenCDISC Validator??? I included and tried again but RoleCodeList is not getting populated.

Please help me with this issue.

Thanks,

Ashok

Hi,

I generated Define.xml through Open CDISC Validator by importing the files of all datasets in .xpt format. But it is not generating the values of the column KEYS in the table 'Datasets for Study define_xml(SDTM 3.1.2)' and ORIGIN,COMMENT columns in all the datasets which are being created(DM,DS,AE,.....)

Please give a solution asap.

Thanks in advance.

Hi,

I generated a Define.xml using the Open CDISC Validator and i used the template which is provided by the Open CDISC which is present in 'opencdisc-validator-1.2.1-bin\opencdisc-validator\config\examples\codelist-template.xls'. After creating the define.xml we are getting the Code value as floating point values instead of numeric values (example 1.0 for 1, 2.0 for 2 etc...) eventhough we are providing the numeric values in Codelist-template.xls.

Please let me know the solution for this issue. Thanks in advance.

I was wondering if there is a specified list (or codelist) of values that go into the origin of variables.  So for ADaM it will most likely be either be Assigned, some SDTM variable or Derived. For SDTM there could be a wider range of possibilities. Most probably will be CRF Page(s) ### or Assigned. There are a few Derived fields such as baseline flags and --DY variables.  I've also used EDT (External Data Transfer) for labs and ECGs that are not collected on the CRF.

It seems that the define.xml created from OpenCDISC is missing the ability to add Origin, comments and possibly a couple other items based on other posts. I'm able to add codelist references, but only the first code is showing up in the codelist area at the bottom. However, the bigger question is, how are define.xml files being created that have ORIGIN filled in and linking to the CRF page? Are people post-processing the file from OPENCDISC or using alternative software/self-made solutions to create theirs?

While comparing the report between OpenCDISC validator v1.1 and v1.2, I noticed that I have significantly more warnings while using v1.2 with respect to Rule-DD0004 which was not present in the validator v1.1. I used OpenCDISC to generate my define.xml and received a similar warning (DD0004 Unknown attribute). For example, DD0004 fires on: CreationDateTime="2010-05-18T09:13:01" in v1.2, but the same string does not present a warning in v1.1.  Can you help me understand what enhancements were made that makes these attributes unknown in v1.2?

Hi, I'm hand-tweaking a define.xml from an initial template generated by OpenCDISC.

One thing that's confusing me is CodeList and ValueList. I think I get the distinction, and it seems to be the norm to use ValueList for things like --TESTCD where you might want to horizontalize a table, and CodeList for results and qualifiers, e.g. ETHNIC.

Hi, I'm getting warning CT0042 (Value for TSVAL not found in TDIGRP controlled terminology codelist). This rule is only applied to rows where TSPARMCD='TDIGRP'. However it doesn't seem possible to supply a user-defined code list which only applies to a subset of rows.

Is there any way to extend the TDIGRP code list (C66787) in this case?

Thanks for any help,

Martin

Hi All,

I am having an error message when validating Define.xml for ADaM datasets. I am not sure what element order was violated. I checked an order of datasets and an order of variables inside of the datasets against their positions in define.xml. Everything looks fine. Would you please help?

Thank you in advance!

Leonid