Create Signal Investigations for Signal Data Sources

You can create Signal Investigations for detected Product-Event Combinations (PECs). Use Signal Investigations to track, evaluate, and confirm safety issues relevant to the medicinal product and across multiple Products and Product Families that are concomitant or interacting with the Signal Investigation’s primary Product. Vault stores Signal Investigations in the Signal Investigations tab.

You can create Signal Investigations for detected PECs that require further analysis from the following data sources:

• PV
• EVDAS
• Literature

Create a Signal Investigation from Statistical Data

Pharmacovigilance (PV) signal data is maintained in Statistical Data records. From a Statistical Data record, start the workflow and then create a Signal Investigation.

Start the Workflow for a Signal Investigation

To start the workflow for a Signal Investigation:

1. Navigate to the Statistical Data tab and select the relevant record.
2. From the Workflow and State Change () icon, select the applicable change state action.
3. On the confirmation dialog, select Yes.

Create a Signal Investigation from a Statistical Data Record

You can create a Signal Investigation from a Statistical Data record:

• From the Signal Investigation field
• From the Open Investigation action

Once complete, Vault creates the Signal Investigation in the Signal Investigations tab.

Populate the Signal Investigation Field

To create a Signal Investigation from the Signal Investigation field on a Statistical Data record:

1. Navigate to the Statistical Data tab and select a record.
2. Select the Edit icon.
3. In the Signal Investigation field, do one of the following:
   • To select an existing Signal Investigation, select the drop-down or the Advanced Search icon to use filters and refine your search.
   • To create a new Signal Investigation, select Create Signal Investigation.
4. If creating a new Signal Investigation, in the Create Signal Investigation dialog, populate the fields as needed and then select Save.
5. Select Save.

Open an Investigation

To create a Signal Investigation using the Open Investigation action:

1. Navigate to the Statistical Data tab.
2. Beside a Statistical Data record, select the Actions menu.
3. Select Open Investigation.

Create a Signal Investigation from EVDAS eRMR Data

EudraVigilance Data Analysis System (EVDAS) signal data is maintained in EVDAS eRMR records. From an EVDAS eRMR record, start the workflow and then create a Signal Investigation.

Start the Workflow for a Signal Investigation

To start the workflow for a Signal Investigation:

1. Navigate to the EVDAS eRMR tab and select the relevant record.
2. From the Workflow and State Change () icon, select the applicable change state action.
3. On the confirmation dialog, select Yes.

Create a Signal Investigation from an EVDAS eRMR Record

To create a Signal Investigation from an EVDAS eRMR record:

1. Navigate to the EVDAS eRMR tab and select a record.
2. In the Signal Investigation field, do one of the following:
   • To select an existing Signal Investigation, select the drop-down or the Advanced Search icon to use filters and refine your search.
   • To create a new Signal Investigation, select Create Signal Investigation.
3. If creating a new Signal Investigation, in the Create Signal Investigation dialog, populate the fields as needed and then select Save.
4. Select Save.

Vault creates the Signal Investigation in the Signal Investigations tab.

Create a Signal Investigation from Literature Data

Literature data is maintained in Literature Articles. When you create a Signal Investigation from a Literature Article, the following scenarios may occur:

Scenario	Criteria	Vault Behavior
One Product results in one Signal Investigation	There is one Literature Article Product. The Product Family field is populated. The Investigation Review Outcome field is not set to No Further Action.	Creates one Signal Investigation. Creates one Literature Data record. Links the related Signal Investigation and Literature Data records together.
Multiple Products result in one Signal Investigation	There are two or more Products. For the rank 1 Product: The Product Family is populated. The Investigation Review Outcome field is not set to No Further Action. For other Products: The Investigation Review Outcome field is left blank.	Creates one Signal Investigation. Creates one Literature Data record for each unique Product Family. Links the related Signal Investigation and Literature Data records together.
Multiple Products result in multiple Signal Investigations	There are two or more Products. The Product Family fields are populated. For each Product, the Investigation Review Outcome field is not set to No Further Action and is not left blank.	Creates one Signal Investigation for each unique Product Family. Creates one Literature Data record for each unique Product Family. Links the related Signal Investigation and Literature Data records together.