Hi all,
While validating a Define-XML file, I encountered some unexpected warnings related to Origin Type:
| BW, BWNOMLBL, Other | DD0073 | Invalid Origin Type value |
|---|---|---|
| BW, BWREASEX, Not Available | DD0073 | Invalid Origin Type value |
According to the rule definition, “Other” and “Not Available” are valid Origin Type values for SEND Define-XML v2.1.
Has anyone experienced this issue before? Do you think this could be a bug in Pinnacle 21?
For reference, I am using:
- Pinnacle 21 CLI: v1.0.9
- Validation engine: FDA 2508.1
I’ve also included the rule description below:
For Define-XML v2.0, the Origin Type attribute must have a value of ‘CRF’, ‘Derived’, ‘Assigned’, ‘Protocol’, ‘eDT’, or ‘Predecessor’ for SDTM and ADaM data and ‘COLLECTED’, ‘DERIVED’, ‘OTHER’, or ‘NOT AVAILABLE’ for SEND data. For Define-XML v2.1, the Origin Type attribute must have a value of ‘Collected’, ‘Derived’, ‘Assigned’, ‘Protocol’, or ‘Predecessor’ for SDTM, ‘Collected’, ‘Derived’, ‘Assigned’, ‘Protocol’, ‘Other’, ‘Predecessor’, or ‘Not Available’ for SEND, and ‘Derived’, ‘Assigned’, or ‘Predecessor’ for ADaM.
Thanks,
Sergio