When a document is uploaded through SiteZone, an Index Task for that document will be made available in the Inbox. Index Tasks require a user to select an index and assign metadata for the document before submitting it to QC.

Users can perform the following actions on an Index Task:

• QC – document will continue through the normal QC steps
• Send back to Site – the document will be sent back to the Site in SiteZone (only available for documents that were requested)
• Ask – request assistance from another user
• Delete – deletes the task and document
• Delegate – Assign the task to another user for Indexing
• Return – sends the task back to the group Inbox

Note: Index tasks may also be created for documents uploaded through eUpload.

To request a document from a site in SiteZone, the following must be true:

• The document is of a type that can be generated from the site
• SiteZone is enabled for that site
• You must have TMF Request Documents group permissions

The option to request a document from a site will display on the Study Item menu as the “Request Document from Site”.  Using this menu option will generate an upload task requesting the document from that site in SiteZone.

Upload Task

While the document is awaiting upload from the site in SiteZone, the task will be available in the eTMF Inbox as an Upload Task.

Upload Tasks in eTMF can be Deleted (from both eTMF and SiteZone), Delegated to another SiteZone user to upload the document, or Returned to the Group Inbox in eTMF.

Once a document has been uploaded from the site, an Index Task will be available in the eTMF Inbox.

Documents that satisfy both of the following requirements have the ‘Send for Signature’ option available on the Tasks panel:

• Document is part of a site that has SiteZone enabled
• Document is indexed to a document type that allows a signature

Note: If the document has already received a Wet Ink Signature, choose the Finalize option instead of the Send for Signature option.

Once the document has been sent to the site for a signature, a ‘Sign Task’ will be available in the Inbox.

Sign Task

Sign Tasks stay in the Inbox until the document has been signed by the specified personnel at the site.

The tasks window on a Sign Task allow the user to Delete the task altogether, Delegate the task to another SiteZone user for signature, or return the task to the eTMF Group Inbox. Normally no intervention is needed in eTMF.

SiteZone can be enabled or disabled for individual sites by going to the Study Home page, selecting the site view of the Metadata panel, selecting the site, and choosing Enable/Disable SiteZone for Site from the Actions menu.

If disabled, no one will be able to access the site in SiteZone.

SiteZone CRAs can be managed from the Study Home page by clicking on the desired Site in the Metadata Panel, Sites View, accessing the site’s actions menu, and then clicking ‘Manage CRAs’.

Note: You must be in the MANAGE_CRA security group to have the ability to Manage SiteZone CRAs. 

You can add an existing user to the list of CRAs by typing their name into the ‘Choose a user to add as a CRA’ box and clicking ‘Add’.

For users that have been added as a CRA, you can choose if they are a Blinded or Unblinded CRA and whether or not they are Active. If a user is an inactive CRA they will not receive emails from the site, will not be able to access the site in SiteZone, and will not be listed as the CRA for the site in eTMF. Contact information for each of the CRAs is also available.

The Manage SiteZone Templates screen allows you to choose which templates you would like to use in SiteZone for various Document Types.

Users in the MANAGE_SITEZONE_TEMPLATES security group can access the ‘Manage SiteZone Templates’ option from the More Actions menu in the Top Bar.

Templates created on the View eTMF Configurations screen will be available for use on the Manage SiteZone Templates screen if they apply to the document type that a template is being selected for.

The Reference Model ID for each Document Type is also displayed here.