The Vault document is under both Site and Country level, why does it only file into the Site-level binder?
This is because eTMF is using the Auto-filling feature. Once a binder exists, Vault automatically places documents into matching binders using the Document Type, Study, Study Country, and Study Site fields.
Documents file into the lowest-level binder possible:
- If only the Study field is populated, the document files into the related Study Master File binder
- If the Country field is also populated, the document files into the related Country Master File
- Likewise, populating the Site field causes the document to file into the related Site Master File
Example: Documents such as IRB approval can be at the Country or Site level.
- Country - IRB approves the study to be run at all sites within a specific country
- Site - IRB approves the study to be run at a specific site
When a document has values in Study, Study Country and Site, it should be a Site-level document. Therefore, it is filed into the Site binder.
When a document has Study and Study Country values on it, it should be a Country-level document. Therefore, it is filed in the Country binder.
Vault Help Documentation: Auto-Filing Documents in TMF Binders