A document that is not planned. The Study Item for the document will not be generated until the document comes in.

Site Master File.

Indication in eTMF that a document is expected to be received via scanning.  Provides a user with the ability to enter document metadata and generate a Transmittal.

Cover sheet displaying metadata for a document to be scanned that is placed in front of a document during scanning.  The transmittal includes a bar code that will allow the scanning system to associate the document with a specific eTMF study item when scanning is complete.

An Example Transmittal

The date that an electronic copy of the document was received for upload to the eTMF.

The approval or finalization date of a source document.

The transmission of a file from an external location into the eTMF system.

The creation of a linked relationship between a document and one or more study items.
(Multi index = more than one study item)

The combination of content and metadata associated with a Study Item.

A document that has been designated as expected or received (even if not expected) in advance for a particular study. Study items may be empty placeholders awaiting content, placeholders that have been fulfilled with content, or placeholders that have been fulfilled by supplying reasons why content will not be collected.