Selecting a Gear on any part of any page will display an Actions Menu. Actions Menus allow the user to access various options for the page or item that the Menu is associated with.
Example:
In the Work Area there are three types Gears.
- Starting on the left side of the screen, the Gear above the Filters will display options for the Filters.
- The Gear directly above the Study Items List will display options for the entire Study Items List.
- The gears next to each Study Item will display options relating to that individual Study Item.
The options that display on each gear may be dictated by the user’s permissions.
Depending on your role, the “More” gear in the Top Bar can lead to the following functions.
eTMF’s Metrics and Reporting lets you create custom views of the status of your TMF.
You can configure the views to fit your role and to see the right level of detail for insight into the progress of your TMF.
You can also drill down to details about sites and studies, as well as statistics and charts to further inform your decisions.
Getting to Metrics and Reports
- From anywhere in the eTMF, click the Metrics button in the top bar to access Metrics and Reporting.
- From Study Home, click on the Metrics bar graphs in the bottom right corner to see those Metrics in more detail.
What Reports Are Available?
Site Metrics is a data-table overview of the progress of sites with filtering to let you focus on specific areas.
Site Metrics are available to all Administrators and Study Owners.
Site Metrics Display
The Site Metrics data-table is helpful for easily viewing the following information about all Sites within eTMF:
- Latest Milestone
- Site Status
- Total Expected Documents
- Count of Final Items
- Count of Past Due Items – If the Site has Past Due items this cell will be Red.
- Count of Nearly Due Items
- Count of Not Yet Due Items
- Count of In Progress Items
This list includes all commonly-used key terms in the IQVIA eTMF Help Pages. Click on the hyperlink for a keyword here or on any Help Page for its definition.
File Review Glossary
Key Concepts of the User Interface:
What is CTMS data?
CTMS (Clinical Trial Management System) data defines the studies, milestones, sites, subjects, investigators and indications that the eTMF system will manage as components of your Trial Master File.
What does CTMS data do?
CTMS data populates many of the options that are available when you work with your eTMF system. For example, when you run the “Create Study” wizard, the choices you see in that wizard come from CTMS data.
CTMS Data Format
The Wingspan eTMF system accepts CTMS data in the form of 7 specfically-named .csv (Comma Separated Value) files.
Do not change the names of these files.
These files are:
- study_details.csv
- site_milestone.csv
- country_milestone.csv
- study_milestone.csv
- subject.csv
- site_investigator.csv
- study_indication.csv
- site.csv
These files can be Uploaded into the eTMF system, or they can be compressed into a single .zip file and uploaded together.
Note: The name of each file must contain the Java name used to specify the file encoding if the file is not encoded as UTF-8. The encoding is period delimited in the name and comes immediately before the “.csv” extension, (e.g., site_investigators.Cp1252.csv). The encoding is optional if the file is UTF-8 (e.g., the assumption is the file is encoded in UTF-8). So study_details.csv will be processed the same as study_details.UTF8.csv. It should be noted that the default encoding in Windows is typically Cp1252. A list of common encodings and their Java name can be found here: http://www.devsphere.com/mapping/docs/guide/encodings.html
How To Upload CTMS Data
To Upload CTMS Data, select the More Actions menu in the Top Bar and select Administration. On the Administration page, select the Actions dropdown next to System Configuration and select Upload CTMS Data.
You can upload CTMS Data by selecting ‘Add File(s)’ or by dragging and dropping a file into the window.
