Users in the Distribute Documents group can Distribute Program Level Documents (such as safety reports) to sites for document types that are marked as Distributable in the eTMF. The document must be Final before it can be distributed. You can choose specific sites to which the document should be distributed.

Distributing a document results in two actions:

• Linking of the document into each study for which a site was chosen (unless it has already been linked into that study). After linking, the Program level document will appear in the Study Item list for the study.
• Creating a record in the Audit Trail of when the document was distributed to the site

How to Distribute a Document

To distribute a document, select the “Distribute Document” option on the document’s Actions menu. On the Distribute Document screen, select which sites the document will be distributed to.

• The document can be distributed to any or all sites for studies associated with its Program that are not locked or archived
• The grid will not display sites to which the document has already been distributed
• Use the filters on the left hand side of the dialog to select sites for only specific studies or countries, or to eliminate sites based on their status or most recent milestone
• To select all displayed sites, select the box above the grid

When the appropriate sites have been selected, click Distribute. You can distribute the document multiple times based on different conditions. Close the dialog when done.

You can generate a distribution report to view distribution information in an Excel file that can be downloaded from the Downloads page.  If the document has been acknowledged by the site, the name of the person who acknowledged the document will display in the report, as well as the date of acknowledgement.

Note that all sites will display in the report, but only the sites selected to receive the document will show a distribution date.