optional define.xml does not seem optional

Pinnacle 21 Support Troubleshooting and Problems
1

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

2

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?

3

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.

4

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?