The Study Startup Specialist Homepage provides a single page to view key information for Startup Specialists, including actionable tasks, milestones, and data related to overdue or high priority items at the Study, Study Country, and Study Site levels. With the Study Startup Specialist Homepage, you can quickly identify actions needed, assess the status of your sites, and navigate to and interact with your data.
Note: This feature is only available on Clinical Operations Study Startup Vaults and requires some configuration by an Admin.
To view the Study Startup Specialist Homepage, you must select a Study record from the context selector. You can select any study that you have permission to view. You can choose to narrow your homepage view by selecting a Study Country and a Site from the drop-down menus in the context selector.
Vault filters any object or document lists on the homepage by the records you choose in the context selector. For example, if Teresa selects Study: VV485 > Study Country: United States > Site: VV485-301, all components of Teresa’s homepage will be specific to the study site, VV485-301.
Startup Specialist Homepage Components
The Study Startup Specialist Homepage contains several widgets that track and display real-time metrics. Depending on the configuration of your Vault, the labels of the widgets that you see in your Vault may be different than the labels listed below.
Site Startup Progress
The Site Startup Progress widget displays a list of sites relevant to the Study or Study Country you chose in the context selector. If you’ve selected a Site in the context selector, the widget will still display other Sites in the selected Study Country. When you select a Site from the Site Startup Progress widget, the homepage updates to reflect data for that Site.
Vault sorts Sites by name and displays key startup details to help you decide which site to focus on: Primary Investigator, Days to Greenlight, and Greenlight Completeness. These fields update as the site’s related Milestone of type Site Greenlight record is updated. Your Admin can configure these fields to automatically populate when a Site is selected.
From this widget, you can perform bulk object record actions, access the Actions menu for each Site, and create new Site records.
Upcoming Site Greenlights & Submissions
These widget display pie chart summaries of open Milestones of type Site Greenlight and Submission Milestone records for the context you’ve selected, grouped by Milestone Risk: On Track, Pending, At Risk, Overdue, and Unknown.
The Milestone Risk field is a formula field on the Milestone object. Vault automatically calculates Milestone Risk based on values in a Milestone record’s Actual Finish Date, Planned Finish Date, and the % Complete fields. Below is the default logic for setting this field, but an Admin can change the thresholds that determine these values:
|Planned Finish Date < 8 Days||Planned Finish Date = 8-14 Days||Planned Finish Date = 15-21 Days||
Planned Finish Date > 21 Days
|Completeness < 25%||At Risk||At Risk||At Risk||On Track|
|Completeness < 50%||At Risk||At Risk||On Track||On Track|
|Completeness < 75%||At Risk||On Track||On Track||On Track|
|Completeness <= 100%||Pending||On Track||On Track||On Track|
If the Planned Finish Date is blank, the Milestone Risk is Unknown. If Planned Finish Date is before the current day, the Milestone Risk is Overdue.
If you hover over a Risk section in one of the pie charts, the hovercard displays the corresponding Milestones records and their Completeness value, sorted by Planned Finish Date. Click a Milestone name to navigate to that record.
Tasks Requiring Attention
The Tasks Requiring Attention widget displays counts of Clinical User Tasks, document workflow tasks, and object workflow tasks related the following objects: Expected Document, Milestone, Milestone Item, Study, Study Communication Log, Study Country, Study Person, and Site for the Study, Study Country, or Study Site you chose in the context selector. Tasks are sorted into three categories: Overdue, Unassigned, and Due Today.
If you click on one of these task counts, the widget toggles to display a grid view of the corresponding tasks. Click a task to navigate to it. To return to the summary view, click Back to tasks requiring attention.
From each task’s Actions menu in this widget, you can choose to Complete workflow tasks, Reassign document workflow tasks, Accept unassigned tasks, or Complete, Assign, or Reassign user tasks, depending on workflow configurations.
The My Tasks widget displays a simplified view of the Vault Home My Tasks page. This widget shows your assigned Clinical User Tasks, document workflow tasks, and object workflow tasks on the following objects: Expected Document, Milestone, Milestone Item, Study, Study Communication Log, Study Country, Study Person, and Site for the selected Study, Study Country, or Study Site.
From the Actions menu, you can choose to Complete tasks or Undo Acceptance (workflow tasks only).
The Upcoming Milestones widget displays a list of open Milestone records for your Study, Study Country, or Site. From this widget, you can perform bulk object actions, access the Actions menu for each Milestone, and create and relate object records. Select a Milestone Category to filter the list of Milestones displayed.
If you hover over a Milestone, a hovercard displays the % Complete, a status indicator icon, a list of Milestone Dependencies, a list of expected documents, and a list of matched documents with each document’s Name, Status, and Version. Learn more about milestone hover cards.
Greenlight Planning & Progress
The Greenlight Planning and Progress widget displays running totals of Greenlight Milestones over time by Baseline Finish Date, Planned Finish Date, and Actual Finish Date.
The first date on the X-axis is the earliest applicable date for a Greenlight Milestone record in your selected context, and the last date is the latest applicable date. The Y-axis represents the count of Greenlight Milestone records for a given day. The vertical line on the X-axis represents the current date. If you hover over an entry on the chart, a hovercard displays the total count of Greenlight Milestone records for that day.
The chart legend identifies the three (3) date groupings: Baseline Finish Date, Planned Finish Date, and Actual Finish Date. Vault sorts Greenlight Milestone records within these date groupings when the corresponding date field falls on or before a date on the X-axis. Click an entry in the legend to add or remove that line from the chart.
If you click the download icon in the upper-right corner of the chart, you can download it in various image formats or as a PDF.
About Milestone Greenlights
The Days to Greenlight field calculates the difference between the current date and the site’s Planned Greenlight Date. When the entry action is configured, Vault sets the Planned Greenlight Date by adding the Target Lag, Site Selection to Greenlight field value from the site’s related Study Country record to the date the site is selected for the study. The Target Lag, Site Selection to Greenlight field automatically defaults to the Default Days, Site Selected to GL field value on the related Country record. When the Planned Finish Date of a site’s related Milestone of type Site Greenlight record is updated, Vault also updates the Days to Greenlight field, unless the Milestone has an Actual Finish Date.
The Greenlight Completeness field on the Site object displays a status indicator icon representing the % Greenlight Activities Complete for that site. Vault updates % Greenlight Activities Complete for a Site whenever the Completeness value is updated on a related Greenlight Milestone record. When the related Greenlight Milestone is complete, Vault no longer updates % Greenlight Activities Complete for the Site. Learn more about how Vault calculates milestone Completeness.
You must have at least View permission on the following objects to see the Study Startup Specialist Homepage components:
- Study, Study Country, and Study Site
- Clinical User Task
- Expected Document
- Milestone Item
- Study Communication Log
- Study Person
- Site Metrics