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About Signal Investigations
Signal Investigations allow you to group Product-Event pairs for one Signal analysis. You can group these pairs across different Signal Product Profiles, MedDRA hierarchy levels (for example, LLT, HLT, HLGT), and MedDRA Queries (for example, SMQs and CMQs).
Prerequisites
Your Admin must enable Signal Investigations before you can use this feature.
Additionally, to include MedDRA queries on an investigation, your Admin must add SMQs and CMQs to the MedDRA Queries library.
Create a Signal Investigation
Perform the following steps to create a Signal Investigation:
- From the navigation bar, go to Signal > Investigations.
- Select Create.
- Complete the following fields in the Details section before saving the page:
Signal Investigation Details Section - Name: Enter a name for the Signal Investigation.
- Signal Product Profile: Select a Signal Product Profile from the dropdown.
- Signal Product Reporting Period: Select a Signal Product Reporting Period from the dropdown.
Upon saving, the system creates the new Signal Investigation in the Triage state.
Add MedDRA Queries to the Signal Investigation
Perform the following steps to add one or more MedDRA Queries to an investigation:
- Go to the MedDRA Queries section and select Create.
A Create Signal Investigation MedDRA Query window appears.
Signal Investigation MedDRA Query Window - Complete the following information before saving the window:
Field Description MedDRA Query Select or enter a MedDRA Query. MedDRA Query Scope Select one or both MedDRA Query Scopes for the MedDRA Query: - Select Broad to specify MedDRA terms where the Scope field is set to Broad
- Select Narrow to specify MedDRA terms where the Scope field is set to Narrow
Add Product-Events to the Signal Investigation
Perform the following steps to add a Product-Event:
- Go to the Product-Events section and select Create.
A Create Signal Investigation Product-Event window appears.
Create Signal Investigation Product-Event Window - Complete the following information before saving the window:
Field Description Product-Event Select or enter a Product-Event to include in the investigation. Investigation Outcome Select or enter an Investigation Outcome at the conclusion of the investigation: - Select Confirmed to indicate the Signal Investigation resulted in a confirmed Signal for the Product-Event.
- Select Refuted to indicate the potential signal is refuted for the Product-Event.
- Select Monitor to indicate the Product-Event is being monitored.
