The Site Activation Progress View allows a study startup team to view document completeness across sites at a glance. To use this view, you must complete several configuration steps:
- Configure Site Activation Progress settings
- Create milestone and EDL item records if they don’t exist and configure relationships between the records
- Populate SIV fields on sites
- Optional: Configure custom permission sets to hide access to Site Activation Progress tab
Note: This feature is only available on Clinical Operations Study Startup Vaults.
How to Enable and Configure Site Activation Progress
Navigate to Admin > Settings > Application Settings and populate the following fields:
- Time Period for “SIV in the Next” Group: Set the period that Vault will consider as “upcoming” when grouping sites in the Site Activation Progress view. If the Site record’s Planned SIV Date is beyond this period, Vault displays it in the Planned group. For example, if the time period is set to 10 days and the Planned SIV Date for site 1405 is 11 days from today, site 1405 appears in Planned.
- Milestone Types to Show & Group By: Select the types of milestones that appear in the Site Activation Progress view. The view automatically groups documents by their associated milestone type and filters out documents associated with an unselected milestone type. Note that Milestone Type is a picklist field associated with the Milestone object; by default, it includes “Start,” “Conduct,” and “Close,” but you can update the picklist items to match your business process and terminology.
How to Set Up the Milestone Item Relationship
When you enable the Site Activation Progress feature, Vault automatically creates the Milestone Item object, which is a relational object supporting a many-to-many relationship between the EDL Item and Milestone objects.
To create these relationships, you first need to edit the page layout for EDL Item and Milestone objects to add a related object section for Milestone and EDL Item, respectively. Once the related object section appears on the record detail page, you can create relationships from the details page for an EDL Item or Milestone record.
The link between EDL Item records and Milestone records (and their Milestone Type) tells Vault which EDL items to include in the Site Activation Progress view.
When you enable Site Activation Progress, you’ll see two new fields on the Study Site object: Planned SIV Date and Actual SIV Date. The progress view uses the Planned SIV Date value to group sites into Overdue, Due In the Next X Days, and Planned categories. The view groups sites into SIV Complete if Actual SIV Date is populated.
How to Make Site Activation Progress Available
After you’ve finished the other configuration steps, the Site Activation Progress tab becomes available for all users with a standard security profile. If your organization wants to limit access, you can assign users to a custom security profile that does not include a permission set with the tab permission.