Create Signal Investigations for Signal Management

You can create Signal Investigations for detected Product-Event Combinations (PECs) that require further investigation, or upon request from a health authority. Use Signal Investigations to track, evaluate, and confirm safety issues relevant to the primary medicinal product and across multiple Products and Product Families or Aggregate Reporting Groups that are concomitant or interacting with the Signal Investigation’s primary Product. Vault stores Signal Investigations in the Signal Investigations tab.

As part of the signal management process, you can create a Signal Investigation from: 

• The Signal Investigations tab
• PEC Periods
• Literature Articles

Prerequisites

Before creating Signal Investigations, consider the following prerequisites:

• To create a Signal Investigation from a PEC Period, your Admin must enable Creating Safety Investigations from PEC Periods.
• To create a Signal Investigation from a Literature Article, your Admin must configure the following:
  • Creating Safety Investigations from Literature Articles
  • Literature Review Process Management
  • Importing Literature References from Databases
  • Literature Coding to Product Family
  • Literature Multi-Product Support
  • Optional: Depending on your business needs, additional features are available for configuration.
• To capture additional information for Signal Investigations, your Admin must add the following fields to the Details section in the Signal Investigation object layout:
  • Description
  • Due Date
  • Validation Outcome Rationale
  • Disposition Rationale
• To track safety issues related to Products that are concomitant or interacting with the primary Product, your Admin must enable Multiple Product Families on Safety Investigations.
• To add a MedDRA Term or MedDRA Query directly on a Signal Investigation, your Admin must configure Adding MedDRA Terms and Queries for Safety Investigations.
• To create Signal Investigations and Signal Investigation Products at the Aggregate Reporting Group level, your Admin must:
  • Enable Signal Calculations for Product Family Combinations
  • Configure Signal Calculations Settings for Aggregate Reporting Groups

Create Signal Investigations from the Signal Investigations Tab

To create a Signal Investigation from the tab:

1. Navigate to the Signal Investigations tab.
2. Select Create. 
3. Complete the fields.
4. Select Save.

Depending on your Admin’s configuration, Vault can monitor and detect when a Signal Investigation enters the Risk Mitigation state and create a series of PVA obligation-related object records to allow you to take the necessary steps to address the related signal event.

About Creating Signal Investigations from PEC Periods

Creating a Signal Investigation from a PEC Period allows you to record details such as the important dates and priority. You can also specify the outcome of your investigation and provide details about relevant data, which is useful for auditing and compliance purposes. To learn more about PEC Periods, see Create and Track Product-Event Combinations.

You can create a Signal Investigation from:

• A single PEC Period
• Multiple PEC Periods

Create a Signal Investigation from a Single PEC Period

To create a Signal Investigation from a single PEC Period:

1. Navigate to the PEC Periods section from one of the following tabs and then select a PEC Period: 
   • Reporting Periods
   • Product-Event Combinations
2. From the All Actions menu, select Open Investigation. 
   Vault creates a Signal Investigation and maps the field values from the PEC Period. 
3. Navigate to the Signal Investigations tab and select the new record. 
4. Select Edit.
5. Complete fields as needed.
6. Select Save.

Create a Signal Investigation from Multiple PEC Periods

To create a Signal Investigation from multiple PEC Periods:

1. Navigate to the Reporting Periods tab and select a Reporting Period.
2. Expand the PEC Periods section and select Show in Tab.
3. On the All PEC Periods page, from the All Actions menu, select All [n] records or Current Page ([n] records). You can perform a bulk action for up to 1,000 records.
4. On the Refine Selection page, clear records to refine the list of PEC Periods from which to create the Signal Investigation, and then select Next.
5. On the Choose Action page, select Record Actions, and then select Next.
6. On the Choose Record Action page, select Open Investigation from Dispositions, and then select Next.
7. On the Confirmation page, review the information and then select Finish.
   Vault creates a Signal Investigation and maps the field values from the first selected PEC Period record. 
8. Navigate to the Signal Investigations tab and select the new record. 
9. Select Edit.
10. Complete fields as needed.
11. Select Save.

About Creating Signal Investigations from Literature Articles

You can create a Signal Investigation for each Product Family on a Literature Article with an independent Investigation Review Outcome that doesn’t result in No Further Action.

When multiple company Product Families are identified in the article, Vault creates a Signal Investigation and Literature Data record for each Product Family on a Literature Article resulting in an independent Investigation Review Outcome that doesn’t result in No Further Action. You can also include multiple Products and Product Families in a Signal Investigation to track related products.

In a scenario with multiple company Product Families where the Investigation Review Outcome is provided for the primary Product Family only (other Product Families have a blank outcome), Vault creates one Signal Investigation for the primary Product Family and a Literature Data record for each Product Family without the review outcome.

For each PEC, identified signals can be linked to a reporting period.

Create a Signal Investigation from Literature Articles

To create a Signal Investigation from a Literature Article:

1. Navigate to the Literature Articles tab.
2. From the All Actions menu next to the related Literature Article, select Open Investigation.
   Vault creates a Signal Investigation and maps the field values from the Literature Article. Vault also creates a Literature Data record linking the Literature Article and the Signal Investigation.
3. Navigate to the Signal Investigations tab and select the new record. 
4. Select Edit.
5. Complete fields as needed.
6. Select Save.

Signal Investigation Fields

The following fields may be available:

Field	Description
Description	Enter a description for this investigation. This field supports up to 150 characters.
Product Family	The Product Family being monitored in this investigation. When you create a Signal Investigation from a PEC Period, Vault maps this value from the PEC Period. Otherwise, select a Product Family from the drop-down or select the Advanced Search () icon to use filters and refine your search. If a Signal Investigation Product does not yet exist, Vault creates one for the Product Family and sets the Rank to 1. In certain scenarios, updating the Signal Investigation Products will update the Product Family at the Signal Investigation level.
Aggregate Reporting Group	The Aggregate Reporting Group being monitored in this investigation. When you create a Signal Investigation from a PEC Period, Vault maps this value from the PEC Period. Otherwise, select an Aggregate Reporting Group from the drop-down or select the Advanced Search () icon to use filters and refine your search. If a Signal Investigation Product does not yet exist, Vault creates one for the Aggregate Reporting Group and sets the Rank to 1. In certain scenarios, updating the Signal Investigation Products will update the Aggregate Reporting Group at the Signal Investigation level.
Primary Source	The reporting source through which Vault detected the signal for evaluation. When you create a Signal Investigation from a PEC Period, Vault maps this value from the PEC Period. Otherwise, select a Primary Source from the drop-down or select the Advanced Search icon to use filters and refine your search.
Literature Database	The literature data source through which Vault detected the signal for evaluation. Select the Advanced Search icon to use filters and refine your search.
Health Authority Database	The health authority data source through which Vault detected the signal for evaluation. Select a Health Authority Database from the drop-down or select the Advanced Search icon to use filters and refine your search.
Start Date	The date when this investigation was started. When you create a Signal Investigation from a PEC Period, Vault sets this field to the date of creation. Otherwise, use the calendar to select the date or enter the date manually.
Detection Date	The date when the related PEC was detected for investigation. Use the calendar to select the date or enter the date manually. When you create a Signal Investigation from a PEC Period, Vault maps this value from the PEC Period.
Priority	Select the priority of the Signal Investigation. The available options include: Critical High Medium Low
Due Date	The date this investigation is due. Use the calendar to select the date or enter the date manually.
Validation Outcome	Select the validation outcome of the Signal Investigation. The available options include: Validated Non-Validated
Validation Outcome Date	The date when the Validation Outcome was set on this investigation. Vault sets this to the current date whenever the Validation Outcome field is updated.
Validation Outcome Rationale	Enter the reason for this Validation Outcome. This field supports up to 500 characters.
Final Disposition	The final outcome of the Signal Investigation. The available options include: Confirmed Refuted
Final Disposition Date	The date when the Final Disposition was set on the Signal Investigation. Vault sets this to the current date whenever the Final Disposition field is updated.
Disposition Rationale	Enter the reason for this Final Disposition. This field supports up to 500 characters.
Summary of Key Data	Enter a summary of the data that led to the outcome of this investigation. This field supports up to 20,000 characters.

Add Signal Investigation Products to a Signal Investigation

Signal Investigation Products allow you to investigate safety issues across multiple Products and Product Families that may be concomitant or interacting with the primary Product in a single Signal Investigation. When you create a Signal Investigation and set the Product Family or Aggregate Reporting Group value, upon saving the record, Vault creates a Signal Investigation Product with a Rank of 1 for this Product Family or Aggregate Reporting Group.

To add Signal Investigation Products to a Signal Investigation:

1. Navigate to the Signal Investigations tab and select a Signal Investigation.
2. In the Products section, select Create.
3. In the Create Signal Investigation Product dialog, complete the following information:
   • Product Family: Select a value from the drop-down or use the Advanced Search icon to use filters and refine your search.
   • Aggregate Reporting Group: Select a value from the drop-down or use the Advanced Search icon to use filters and refine your search.
   • Product: Select a value from the drop-down or use the Advanced Search icon to use filters and refine your search. If a Product is already referenced on the Product Family, you can leave this field blank.
   • Rank: Enter the rank number. Only a single rank 1 Signal Investigation Product can exist for the Signal Investigation. If you set the rank to 1 while another already exists, Vault sets the other Signal Investigation Product rank to blank.
4. Select Save or Save + Create to save the record and create another.

Vault creates a new Signal Investigation Product in the Products section of the Signal Investigation. For more information about ranking logic and how the Product Family or Aggregate Reporting Group at the Signal Investigation and Signal Investigation Product levels relate, see the scenarios below.

Scenarios

This section describes Vault behavior and ranking logic when you:

• Update the Product Family or Aggregate Reporting Group on the Signal Investigation
• Update information on the Signal Investigation Product

The following table describes Vault behavior when you update the Product Family or Aggregate Reporting Group at the Signal Investigation level:

Scenario	Vault Behavior
No Signal Investigation Products exist (due to a new Signal Investigation being created or a user deleting all Signal Investigation Products)	Creates a Signal Investigation Product and sets the Product Family or Aggregate Reporting Group to that of the Signal Investigation Sets the Rank to 1 on the Signal Investigation Product
A single Signal Investigation Product exists on the Signal Investigation	Updates the Product Family or Aggregate Reporting Group on the Signal Investigation Product to that of the Signal Investigation If the Rank field is blank, sets it to 1
Multiple Signal Investigation Products exist	Vault does not update any Signal Investigation Products
When you clear the Product Family or Aggregate Reporting Group value on the Signal Investigation	Vault does not update any Signal Investigation Products

The following table describes Vault behavior when you update information, such as the Product Family and Rank, at the Signal Investigation Product level:

Scenario	Vault Behavior
When you update the Product Family or Aggregate Reporting Group on the Signal Investigation Product and it is the only one that exists on the Signal Investigation	Updates the Product Family or Aggregate Reporting Group at the Signal Investigation level to that of the Signal Investigation Product
When you update the Product Family or Aggregate Reporting Group on a rank 1 Signal Investigation Product	Updates the Product Family or Aggregate Reporting Group at the Signal Investigation level to that of the Signal Investigation Product
When you create a new Signal Investigation Product and it is the only one that exists on the Signal Investigation	Sets the Rank field to 1, even if you set a different number or leave this field blank Updates the Product Family or Aggregate Reporting Group at the Signal Investigation level to that of the Signal Investigation Product
When you create a rank 1 Signal Investigation Product and multiple Signal Investigation Products already exist	If an existing Signal Investigation Product of rank 1 already exists, Vault clears the Rank value of the existing record Updates the Product Family or Aggregate Reporting Group at the Signal Investigation level to that of the Signal Investigation Product
When you update the Rank value on a Signal Investigation Product to 1	If an existing Signal Investigation Product of rank 1 already exists, Vault clears the Rank value of the existing record Updates the Product Family or Aggregate Reporting Group at the Signal Investigation level to that of the Signal Investigation Product
When you update the Rank value of a rank 1 Signal Investigation Product to a different number	Vault does not update the Product Family or Aggregate Reporting Group at the Signal Investigation level
When you delete a rank 1 Signal Investigation Product	Vault does not update the Product Family or Aggregate Reporting Group at the Signal Investigation level

Add a MedDRA Term or MedDRA Query to a Signal Investigation

To add either a MedDRA Term or MedDRA Query directly on a Signal Investigation:

1. On the Signal Investigation, expand the Events section.
2. Select Create.
3. In the Create Signal Investigation Event dialog, complete the following information:
   • Name: Enter a Name for this Signal Investigation event.
   • MedDRA: Use the drop-down or the Advanced Search icon to select a MedDRA Term. You can select either a MedDRA Term or a MedDRA Query, but not both.
   • MedDRA Query: Use the drop-down or the Advanced Search icon to select a MedDRA Query. You can select either a MedDRA Term or a MedDRA Query, but not both.
4. Select Save.