This report provides a list of all users with details of the specific privileges and access they have to a study, if any. It can be generated from the More menu by users in the TMF Run User Reports group.
Leave the Users field blank to generate the report for all users.
Go to More, Downloads to see report results.
This report provides a summary of information on the account details and activities of selected user(s). It can be generated from the More menu by users in the TMF Run User Reports group.
Leave the Users field blank to generate the report for all users.
Go to More, Downloads to see report results.
This report provides information on completed workflow tasks. It can be generated from the More menu by users in the TMF Run User Reports group.
Leave the Users field blank to generate the report for all users.
Go to More, Downloads to see report results.
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:
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 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.
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:
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 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.
Once a study has been locked, it can be archived
To archive a study, navigate to the study’s Study Home Page Action Menu and select the Archive Study option.
This will open the Archive Study window, shown below
Archiving restricts access to the study and adds a named archivist.
Note: Archived studies can be exported by any user with rights to export the study.
Any user with membership in the TMF Archivist group can be designated as a study archivist.
Archiving a study revokes permission of all contributors, document specialists and readers to access the study.
Study Owners, Business Administrators, and Regulatory Agency users still have access to Archived studies and can view study Metrics and run Reports.
Note: Submit a request to helpdesk@mywingspan.com to begin the process of restoring an archived study to active status.
The Distribution Excel report provides information about which sites have had documents distributed to them. When SiteZone is in use, it will also provide information about acknowledgement date and user.
The View Distribution Report Menu Option is available on the Actions menu for a Program Level document if all of the following are true:
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.
