Sections in This Article
About Signal Management
The Signal > Product-Events tab displays tracked Product-Events. You can also access the Signal Workbench for each tracked Product-Event record for a quantitative Product-Event analysis.
There are two methods to track a Product-Event:
Track a Product-Event from the Signal Detection Dashboard
- Go to Signal > Signal Product Profiles.
- Select Open Detection from the All Actions (
) menu beside the applicable Signal Product Profile. - Navigate to the Product-Event Combinations grid at the bottom of the page.
- Select Track beside the applicable Product-Events.
Track a Product-Event from the Product-Event Combinations Grid
Result
A Product-Event record is created in the Signal > Product-Events tab:
Select the record in the Product-Events tab to view the Product-Event details and the data source calculations.
See Use Signal Detection for more information on the Detection Dashboard.
Manually Create a Product-Event
There are two methods for manually creating tracked Product-Events:
- You can select the Create button on the Product-Events page. Complete the Create Product-Event page using the Product-Event field reference below.
- Use the Vault Loader to import Product-Events in bulk.
Prerequisites
An administrator must enable manual Signal tracking.
Product-Event Fields
This section describes the standard fields available for data entry when you manually create a Product-Event from the Product-Events tab. The fields are arranged in the order they appear on the page layout provided in the Vault Signal template. You may see additional fields or a different layout, depending on your Vault’s configuration.
Use the Details section to specify general information about the Signal you are monitoring.
| Field | Description |
|---|---|
| Product-Event | (Required) The identifying name of the detected Product-Event. Enter a name for the Product-Event you are creating. Note The system automatically populates this field when the Product-Event is tracked from the Signal Detection Dashboard. |
| Signal Product Profile | (Required) The Signal Product Profile associated with the detected Product-Event. Select an option from the dropdown menu. Once a Product-Event is created, this field cannot be edited. If you select a different value, you cannot save the record. |
| Adverse Event Term | (Required) The coded MedDRA Adverse Event Term for the detected Product-Event. Select an option from the dropdown menu. Once a Product-Event is created, this field cannot be edited. If you select a different value, you cannot save the record. |
Note The system prevents you from creating the Product-Event if the selected Adverse Event Term and Signal Product Profile pair already exist.
Upload Product-Events with Vault Loader
Another method for manual Product-Event creation is importing Product-Events in bulk using Vault Loader.
Go to Business Admin (Quick Access) > Loader. See Vault Loader: Create, Update & Delete Object Records for more information on how to use this tool.
Product-Event Lifecycle States
The Product-Event object comes with the standard Product-Event Lifecycle and the following standard lifecycle states:
| Field | Description |
|---|---|
| Triage | The initial Lifecycle State for a Product-Event record. |
| Validated | This Lifecycle State indicates the Product-Event was validated with sufficient evidence to justify a causal association with the Product. |
| Regulatory Verdict - Monitor | This Lifecycle State indicates the Product-Event record is monitored. |
| Regulatory Verdict - Refuted | This Lifecycle State indicates a "False" Product-Event with no causal association with the medicinal Product. |
| Closed | This is an end state of a Product-Event that does not require further assessment or processing. |
Depending on your Vault’s configuration, you may see the Lifecycle Stages Chevron panel at the top of the Product-Event page. The panel shows what stage the Product-Event is in:
Note Depending on your Organization, the Product-Event Lifecycle and the Product-Event Lifecycle Stages may be configured differently in your Vault. Refer to your standard operating procedures for more information.
