The Study Management Homepage provides a single page for Study Managers and Monitors to access key information, status, metrics, and data at the Study, Study Country, and Site levels and act on that information.
To access the Study Management homepage:
- Navigate to Study Management > Study Management > Homepage.
Homepage
The Study Management Homepage doesn’t show any information until a Study is selected. A Study, Study Country, and/or Site must be selected in order to populate the Study Management Homepage with information.
Use the selected Study, Study Country, or Site link to navigate to that record. When the Select Study, Select Study Country, and/or Select Site is populated, the Study Homepage displays the related information into several sections:
- Study Details
- Summary Metrics
- Monitoring Plan
- My Tasks
- Study Enrollment Status
- Study Quality
If only Study is selected, all information related to that study will be displayed, including all study countries and sites.
If a more focused view of the study is desired, you can drill down to the Study Country or Site level to only view information about the specific study country, or site.
Details
This section shows:
Key Milestone dates for the selected Study, Study Country, or Site. As a study progresses, milestones are recorded at the Study, Study Country, and Site level and will display here. Milestones play a key part in driving the efficiency and timeliness of a study.
In this section you can:
Select Create Site Communication Log from the Actions menu to record a site communication
Select View Site Communication from the Actions menu to see all site communications for the selected Study, Study Country, or Site.
Summary Metrics
This section shows:
- Metrics, such as subject enrollment rate, percentage of enrolled subjects, and percentage of completed subjects for the selected Study, Study Country, or Site.
In this section you can:
Hover over a percentage to show details about the metric.
Select Summary Metrics from the Actions menu to see all enrollment metrics for the selected Study, Study Country, or Site.
Select Subject Status from the Actions menu to see all subjects for the selected Study, Study Country, or Site.
Monitoring Plan
This section shows:
- A list of any monitoring visits that have been created for the selected Study, Study Country, or Site along with their Planned Start Date and Lifecycle State. At the Site level, you can also see the Actual Visit Start Date.
In this section you can:
- Study Managers and Monitors can create new visits by clicking + Create.
- Export the visible table as CSV or Excel from the Action menu.
My Tasks
This section shows:
- Any tasks that have been assigned to you and the Task Due Date.
In this section you can:
- Click the Task Name to directly access the specific task inside of Vault.
- Hover over the Task Name and select Reassign from the Actions menu to reassign the task to another user.
- Hover over the Task Name and select Complete from the Actions menu to complete the task.
Enrollment Status
This section shows:
- Enrollment metrics by status for the selected Study, Study Country, or Site as a graph of the number of subjects enrolled over time.
In this section you can:
- Hover over the yellow exclamation sign, if visible, to display the missing data of the Study Enrollment.
- Hover over any point on the graph to display specific details of the subject status.
- Hover over the blue diamond in the top right of the graph display details of the enrollment status. Clicking the Download icon allows you to download the graph as a PNG, JPEG, or PDF.
- Click one or more of the Subject Status filters to toggle its representation in the graph.
Quality
This section shows:
- Color-coded graphs for issues and follow-up items for the selected Study, Study Country, or Site:
- The left graph displays metrics of protocol deviations and observations.
- The right graph displays metrics of follow up items by priority.
In this section you can:
- Hover over the data points on the graph to see more details.
- Click any of the Severity or Category filters to toggle its representation in the graph.
- Click the Status dropdown to filter either graph by a specific category.
- Click the Action menu to create a new Follow-up item or Clinical User Task.