Vivarcus Help Center

EDL & Expected Documents

What Is an EDL

The EDL (Expected Document List) is the "receivables checklist" of the TMF: it describes which documents should be collected, how many copies, and whether each is required. Admins configure EDLs via templates, and they are generated automatically onto the study (and its countries/sites) by the Plan Study action.

EDL entries are called Expected Documents (EDL Items). The system measures document completeness against the EDL, and uses it as the source of filing locations for automatic archiving.

Creating documents from an EDL Item is recommended — the system carries over fields such as Study and Classification, which maximizes matching success:

  1. Open the study → Expected Documents list, and open any entry's detail page.
  2. The detail page shows Document Type / Classification, # Expected, Completeness, etc.; the Matched Documents section is initially empty.
  3. All Actions → Create Document, choose a creation method (Upload / Placeholder / From Template), fill in the Name and upload the file, then save.

Note

Creating from an EDL Item only pre-fills fields; the match relationship is established automatically after the document is saved.

Matching Rules

The correspondence between documents and EDL Items is maintained by automatic matching. The system compares configured matching fields (typically Study, Study Country, Site, Classification, etc.):

  • All configured matching fields equal → match established
  • A field empty on both sides → treated as equal
  • A value on one side and empty on the other → no match

When creating documents manually, make sure these fields align with the EDL Item.

Common Actions

ActionPurpose
Match DocumentsRuns one matching pass for the entry; refreshes Matched Documents and counts
Update Related Expected DocumentsSyncs # Expected and Requiredness to related entries of the same study (e.g. country/site-level counterparts)
Create DocumentCreates a document from the entry (Upload / Placeholder / From Template)

Note

Update Related Expected Documents syncs only counts and requiredness, not document matches.

Checking Completeness

Counts and status on the entry detail page:

FieldMeaning
All Doc CountTotal number of matched documents
Steady State Doc CountApproved steady-state documents among them
CompletenessShows Complete when the threshold is met

Note

If All Doc Count has a value but Steady State is 0, the matched documents are not yet approved; complete the approval workflow first.

Troubleshooting

SymptomSuggestion
Matched Documents is emptyVerify the document's Study, Classification etc. match the EDL Item; wait a few seconds and refresh, or run Match Documents
Completeness stays Not StartedThe document must be saved and all matching fields aligned
Related entries unchanged after Update RelatedVerify that corresponding country/site-level entries exist in the same study

Required Permissions & Roles

TypePermissionControls
ObjectEDL / EDL Item: Read, EditViewing lists and entries, editing # Expected and Requiredness
Object actionEDL Item: Create Document, Match Documents, Update Related Expected DocumentsCreating documents from entries, manual matching, syncing related entries
ObjectDocument: Create, EditSaving new documents (matching happens automatically after save)

Document Contributor has read/write on EDLs and documents; read-only roles (e.g. External Inspector) can view Matched Documents and counts but cannot run actions.