Vault allows you to manage Monitoring Events across multiple Sites using Monitoring Schedules. Events can be manually scheduled or applied in bulk from an approved Monitoring Scheduling Template.
To configure Monitoring Schedules:
- Add the Site Monitoring Schedule to the Study Site object.
- Add the Monitoring Schedule Templates page layout section to the Study or Study Country objects, as needed.
- Add the Create Monitoring Schedule Items from Template user action to the Monitoring Schedule object.
- Optional: Add a workflow step to run the Create Monitoring Schedule Items from Template system action.
- Configure the appropriate Object Lifecycle steps or workflows for approving a Monitoring Schedule Template and related Monitoring Schedule Template Items.
- Configure the appropriate Object Lifecycle steps or workflows for approving a Monitoring Schedule and related Monitoring Schedule Items.
- Optional: Add the Monitoring Schedule Site Parameter to the Study Site object page layout.
Monitoring Scheduling Templates
You can create Monitoring Schedule Templates on Study and Study Country records. Each template includes a list of Monitoring Schedule Template Items and is associated with a Monitoring Schedule Parameter. For example, if you wish to have risk-based schedules, you can create High Risk, Medium Risk, and Low Risk Monitoring Schedule Parameters.
Each Monitoring Schedule Item has the following fields:
- Milestone Type
- Monitoring Event Type
- Monitoring Visit Method
- Recurring (Yes/No)
- Recurring Frequency: If the previous field is Yes, enter the number of days after which the event recurs.
- Application Role and Study Team Role: These two fields determine the CRA assigned when the Monitoring Event is created.
- Sequence: This field is required prior to approving a monitoring schedule and must be unique for all related items in a Monitoring Schedule. If multiple valid Monitoring Schedule Items are eligible to create Monitoring Events, the highest sequence number determines the recurring frequency.
- Minimum Window
- Maximum Window
Site Monitoring Schedules
Approved Monitoring Schedule Templates with corresponding Monitoring Schedule Template Items can be applied to a site’s Monitoring Schedule via a workflow step or user action, depending on the configuration.
If a Monitoring Schedule Template is approved for both a Study and Study Country, the Study Country’s template is used. If it is only present for the Study, the Study’s template is used. If configured, the Monitoring Schedule Parameter is also used to determine the correct Monitoring Schedule Template to apply.
Once the site’s Monitoring Schedule moves to its Approved lifecycle state, Vault then creates Monitoring Events directly from the site’s Monitoring Schedule Items. Vault automatically uses the specified Monitoring Event Type and Milestone Type. The Days from Initiation field specifies the time period for the initial expected Baseline Start Date. If the event is recurring, subsequent Baseline dates are set based on the Recurring Frequency. The Minimum and Maximum Dates allow you to define the expected time frame for a Monitoring Event and can be used for reporting purposes.
If your organization uses custom Monitoring Event Types, you can add them to your Monitoring Schedules and Monitoring Schedule Templates. Vault will automatically create the custom Monitoring Events with matching Milestone Types once you have configured the event types and corresponding milestones.
Adding the Application and Study Team Roles allows automatic matching to assign a CRA to the Monitoring Event. If a Study Person is both defined and active for the Study Team Role on the Study Site, Study Country, or Study and if the End Date is either blank or greater than the Baseline Visit Start Date, the Study Person will populate in the Monitoring Event created from the item. Vault first evaluates the Study Site, then the Study Country, and then the Study when attempting to assign the CRA.
Note: Vault only assigns the CRA if one and only one Study Person is assigned to the role. In other words, if there are multiple Study Persons assigned to the same role, Vault does not default the CRA.
Monitoring Event Schedule Parameter
The Monitoring Schedule Parameter field is available to ensure the Site uses the correct schedule when set on a Study Site. For example, you can specify additional Monitoring Events for a Site that requires more frequent visits by ensuring the Monitoring Schedule Parameter matches the desired template.