To facilitate the sharing of File Review information, you can export all Review Items and Action Items associated with a specific File Review to an Excel report.
To export a File Review report, select “Export File Review Report” from the Actions Menu of a specific File Review (shown above) or from the File Review List’s Actions Menu (shown to the right). A message alerts you that the export is in progress.
To view the report, access the Downloads area in eTMF by selecting “View Downloads” from the More Actions menu in the Global Header. From the list of downloads, find and select the report with a Download Type of “File Review Export” and the appropriate date/time.
The report contains two tabs. The Review Items tab displays all Review Items from the File Review and their associated metadata, while the Action Items tab displays all Action Items from the File Review and their associated metadata.
The File Review Dashboard provides an at-a-glance view of File Review progress in a visually robust and interactive display. The dashboard contains three sections:
- Completeness Report
- File Review Defect Analysis Report
- Filters Panel
Each section can be hidden to enlarge the display of the other sections, as shown below.
The Completeness Report section of the dashboard shows two pie charts-one for Review Items and one for action items. Each pie chart shows the proportion of existing items in different statuses. If you hover over a portion, a tool tip displays the actual number of items in the status and its relative percentage to the whole. This information enables you to take action or investigate further where needed.
The Defect Analysis Report section initially displays a bar chart of Action Items by Problem Type. This allows you to see the types of issues that are occurring most frequently. If you hover over a particular bar on the chart, a tool tip displays the specific number of Action Items in the File Review with that issue. Use the toggle to display a bar chart of Action Items by Issue Category. By switching to the Issue Categories view, you can view issues at a more granular level.
The Filters panel allows you to limit the information displayed by facet. For example, you can select to view File Review information for a specific study, Review Type or Review Manager.
A user with at least TMF View File Reviews permissions and who has access to at least one File Review* can view content within the File Review Dashboard.
To view the dashboard, select the “File Review Dashboard” option from one of the following menus:
- File Reviews List Page Actions Menu
- File Review Actions Menu
- Review Items List Page Actions Menu
- File Review Reports
*Access to specific File Reviews is controlled by the groups specified in each File Review Template.
Before File Reviews can be created, one or more File Review Templates must be configured by a Business Administrator or other user with TMF Manage File Review Templates permissions. A File Review Template defines the characteristics for a particular type of File Review, including the following:
- The minimum percentage of Study Items to include as Review Items
- The types of Study Items to include as Review Items (e.g., empty Study Items)
- Mandatory Document Types
- Excluded Document Types
- Limits on Finalized Documents and Empty Study Items
- The groups of users who can create and manage, conduct, and view File Reviews
Once templates are defined, authorized users can create new File Reviews based on the templates.
Note: A File Review Template must be made effective for it to be available for use during File Review creation.
The File Review Templates List Page in eTMF displays a list of File Review Templates defined and options for managing those templates. From the File Review Templates List Page, you can also create new File Review Templates.
To access the File Review Templates List Page, select “View Configurations” from the More Actions Menu in the Global Header and select “File Review Templates” from the Breadcrumb Menu.
