Hi Aadesh,
No, Analysis Results Metadata is not implemented in Community 2.02 and upcoming v2.2.
Kind Regards,
Sergiy
Sergiy,
If I could follow up, and get more clarity, please. I took the adam define.xml 2 from the cdisc web site and tried to validate it using opencdisc 2.0.2, and there were validation errors. I wouldn’t expect CDISC to release this example if there were validation errors. Hence, are you saying that the validation itself is not available, or the generation, or both?
Thanks,
Dan.
Hi Dan,
There are 2 reported validation issues for CDISC define.xml v2.0 sample ADaM define file. Both of them are false-positive.
It’s because a current version of OpenCDISC Validator uses only the most recent version of CDISC Control Terminology and limited to SDTM CT only for validation of define.xml file. It’s already fixed in OCE v3.0 and will be added into a new Community version.
Issue # 1. DD0027: “C-Code not found in CDISC Controlled Terminology”. - ADaM CT is not used for validation of define.xml file.
Issue #2. DD0028: “CodedValue mismatch”. - CDISC sample define.xml uses a term “PROTOCOL VIOLATION”, which was changed to “PROTOCOL DEVIATION” term in recent versions of CDISC CT.
Kind Regards,
Sergiy
Thanks Sergiy, but here is the results of define are here, from trying to validate against the analysis results package release earlier this year.
I generated a define file and tried to insert my own ARM, and got same results. The errors here are more extensive than what you cite.
|
DEFINE |
|||||
|
DD0008 |
Element ‘Description’ in wrong position within Define.xml |
Error |
8 |
||
|
DD0008 |
Element ‘def:DocumentRef’ in wrong position within Define.xml |
Error |
6 |
||
|
DD0008 |
Element ‘def:WhereClauseRef’ in wrong position within Define.xml |
Error |
4 |
||
|
DD0027 |
C-Code not found in CDISC Controlled Terminology |
Error |
2 |
||
|
DD0028 |
CodedValue mismatch |
Error |
1 |
||
|
DD0004 |
Unknown attribute ‘href’ |
Warning |
1 |
||
|
DD0007 |
Unknown element ‘arm:AnalysisResultDisplays’ |
Warning |
1 |
||
“Define.xml is leading”.
We developed define.xml to allow sponsors to submit the metadata of their submission in a machine-readable format. So, the define.xml is “the truth of the sponsor”. For example, if the contents of a codelist in the define.xml deviates from what is in CDISC controlled terminology (CDISC-CT), it still is “the truth of the sponsor”. This allows for earlier versions of CDISC-CT to be used, for extended codelists and even for deviating codelists. In any of these cases, it remains “the truth of the sponsor”.
Essentially, any validation of define.xml should be done using the following steps (also see the “XML Schema Validation for define.xml whitepaper” on the CDISC website):
a) validation of the define.xml against the XML-Schema. This ensures good part of structural correctness
b) validation against any other rules from the specification, like the „ItemRef-ItemDef“ rules. This can e.g. be accomplished by Schematron technology. This further ensures structural correctness and technical conformity against the define.xml standard
c) validation of the CONTENT of the define.xml against a specific version of SDTM and SDTM-IG, ADaM and ADAM-IG, SEND and SEND-IG. Essentially this is about the presence and order of variables and their datatypes.
But ONLY when the user wants that, for example when the sponsor envisages an FDA submission. Such an optionality can easily be accomplished by a checkbox in the graphical user interface.
d) validation of the contents of the codelists in the define.xml (the „sponsors thruth“) against a specific version of by CDISC published controlled terminology. CDISC publishes each version of CDISC-CT as XML, so it should easily be possible to allow the user to choose against which version of CDISC-CT validation should be performed.
But ONLY when the user wants that. As the codelists provided provided by the sponsor in the define.xml is the „sponsors thruth“ it should be possible to NOT validate the codelists in the define.xml against any published CDISC-CT. For example, in case of a legacy study, it does not make any sense to validate used codelists against the newest CDISC-CT. Also this could be accomplished by a checkbox in the graphical user interface.
This is my personal opinion, but I am sure it is completely in line with our ideas about the purpose of define.xml when we started developing it and especially when we published define.xml 2.0.
Thanks Josef. The problem we face is that, not being XML experts, will the file we submit be machine readable, if there are validation errors. The errors that arise from validating the define file are much more extensive than the 2 above.
Indeed, I generated a define.xml file myself, and then manually added the ARM. Validating define.xml, there were errors abound. Maybe we did something wrong, so I tried validing the define file with ARM that’s provided on the CDISC website. Same errors:
Hence, is the OpenCDISC tool equipped to validate this file? And ultimately, is the define still machine readable if there are errors?
|
DEFINE |
|||||
|
DD0008 |
Element ‘Description’ in wrong position within Define.xml |
Error |
8 |
||
|
DD0008 |
Element ‘def:DocumentRef’ in wrong position within Define.xml |
Error |
6 |
||
|
DD0008 |
Element ‘def:WhereClauseRef’ in wrong position within Define.xml |
Error |
4 |
||
|
DD0027 |
C-Code not found in CDISC Controlled Terminology |
Error |
2 |
||
|
DD0028 |
CodedValue mismatch |
Error |
1 |
||
|
DD0004 |
Unknown attribute ‘href’ |
Warning |
1 |
||
|
DD0007 |
Unknown element ‘arm:AnalysisResultDisplays’ |
Warning |
1 |
||
Hi,
Any updates on when Analysis Results Metadata will be supported.
Jacques
Hi,
Is creation of Analysis Results Metadata in define.xml possible with Pinnacle 21 enterprise?
If yes, what are the inputs needed by the tool for the same?
Shraddha
Yes, it will be included into a new release by the end of 2016
Is it possible to create ARM with the Community Edition? I believe it is possible in Enterprise. If not yet, will there be a release date when the feature is supported in Community?
Hi,
Is CDISC Analysis Results Metadata v1.0 for Define-XML v2 currently implemented in Opecdisc community 2.02 version?
Please do let me know your thoughts.
Thank you.
Aadesh