All,
Site ID is an important term, but it's not required for every document / content item in the eTMF - this maps to the TMF RM.
As a term from the eTMF domain metadata class, Site ID is already included in metadata (as can be seen from previous meeting slides).
Since the term Site ID is part of the eTMF domain, and, since its not 'Required' for system core technology/architecture, addressing details of this term should be addressed in the Phase 2 eTMF domain term discussions, as per the TC charter.
1-What are Required metadata terms?
Required MD terms must be applied to EVERY document/content item in the eTMF and must have a value. For the eTMF domain class, REQUIRED terms are marked in the table with a red asterisk*.
2-What is core metadata?
Core metadata is the essential, concise and most minimal set of metadata that's needed to characterize the core system as modeled without any specific domain metadata. To enable system interoperability, less 'required' metadata is better than more.
>We did approve adding the concept/term 'Sponsor' to all eTMF content, but this is a 'Required' term, and it applies to all content in the eTMF. Site ID doesn't however apply to all content in the eTMF, only to selected documents/items. Therefore it
should not be considered as 'Required' MD in Phase 1.