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optional define.xml does not seem optional
Forums: Troubleshooting and Problems
SergiyDefine.xml is still optional for validation of datasets
Hi Lance,
While Define.xml is required by both FDA and PMDA, it's still "optional" in terms of validation of datasets.
Kind Regards,
Sergiy
I should clarify, it looks…
I should clarify, it looks like the validator is doing no other processing because it doesn't see a define.xml file. I expect to see some evidence that it checked other data points. Shouldn't something else be listed aside from just the "Missing define.xml file" error?
Define.xml
Sergiy already mostly said it: a set of submission files without a define.xml just doesn't make sense.
Reason is that the define.xml is the "sponsor's truth" about the metadata of the submission.
Ideally, a validation should run as follows: the submission data is validated against the sponsor's truth (the define.xml) which then is validated against the "CDISC truth" (the SDTMIG/ADaMIG rules) and the corresponding "FDA truth" (the FDA rules).
Without having the "sponsor's metadata truth" (the define.xml), you cannot do any serious validation.
I am trying to run the validator on an ADaM dataset without passing a define.xml file. The report runs, but it lists only "Missing define.xml file" with severity of "Reject" under the issues summary and doesn't seem to do any other processing. What am I missing? How can I run the validator without using define.xml?