Create Safety Investigations for Signal Management

Learn how to create Safety Investigations for Product-Event Combinations (PECs) that require further investigation, or upon request from a health authority.

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

About Safety Investigations

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

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

The Safety Investigations tab
PEC Periods
Literature Articles

Prerequisites

Before creating Safety Investigations, consider the following prerequisites:

To create a Safety Investigation from a PEC Period, your Admin must enable Creating Safety Investigations from PEC Periods.
To create a Safety 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 create more detailed Safety Investigations, your Admin must enable Capturing Additional Information for Safety Investigations.
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 Safety Investigation, your Admin must configure Adding MedDRA Terms and Queries for Safety Investigations.

Create Safety Investigations from the Safety Investigations Tab

To create a Safety Investigation from the tab:

Navigate to the Safety Investigations tab.
Select Create.
Complete the fields.
Select Save.

About Creating Safety Investigations from PEC Periods

Creating a Safety 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 Safety Investigation from:

A single PEC Period
Multiple PEC Periods

Create a Safety Investigation from a Single PEC Period

To create a Safety Investigation from a single PEC Period:

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

Create a Safety Investigation from Multiple PEC Periods

To create a Safety Investigation from multiple PEC Periods:

Navigate to the Reporting Periods tab and select a Reporting Period.
Expand the PEC Periods section and select Show in Tab.
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.
On the Refine Selection page, clear records to refine the list of PEC Periods from which to create the Safety Investigation, and then select Next.
On the Choose Action page, select Record Actions, and then select Next.
On the Choose Record Action page, select Open Investigation from Dispositions, and then select Next.
On the Confirmation page, review the information and then select Finish.
Vault creates a Safety Investigation and maps the field values from the first selected PEC Period record.
Navigate to the Safety Investigations tab and select the new record.
Select Edit.
Complete fields as needed.
Select Save.

About Creating Safety Investigations from Literature Articles

You can create a Safety 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 Safety 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 Safety 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 (1) Safety 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 Safety Investigation from Literature Articles

To create a Safety Investigation from a Literature Article:

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

Safety 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 Safety 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 Safety Investigation Product does not yet exist, Vault creates one (1) for the Product Family and sets the Rank to `1`. In certain scenarios, updating the Safety Investigation Products will update the Product Family at the Safety Investigation level.
Primary Source	The reporting source through which Vault detected the signal for evaluation. When you create a Safety 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 Safety 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 Safety Investigation from a PEC Period, Vault maps this value from the PEC Period.
Priority	Select the priority of the Safety 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 Safety 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 Safety investigation. The available options include: Confirmed Refuted
Final Disposition Date	The date when the Final Disposition was set on the Safety 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 Safety Investigation Products to a Safety Investigation

Safety 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 Safety Investigation. When you create a Safety Investigation and set the Product Family value, upon saving the record, Vault creates a Safety Investigation Product with a Rank of 1 for this Product Family.

To add Safety Investigation Products to a Safety Investigation:

Navigate to the Safety Investigations tab and select a Safety Investigation.
In the Products section, select Create.
In the Create Safety 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.
- 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 Safety Investigation Product can exist for the Safety Investigation. If you set the rank to 1 while another already exists, Vault sets the other Safety Investigation Product rank to blank.
Select Save or Save + Create to save the record and create another.

Result

Vault creates a new Safety Investigation Product in the Products section of the Safety Investigation. For more information about ranking logic and how the Product Family at the Safety Investigation and Safety Investigation Product levels relate, see the section below.

Scenarios

This section describes Vault behavior and ranking logic when you:

Update the Product Family on the Safety Investigation
Update information on the Safety Investigation Product

The following table describes Vault behavior when you update the Product Family at the Safety Investigation level:

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

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

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

Add a MedDRA Term or MedDRA Query to a Safety Investigation

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

On the Safety Investigation, expand the Events section.
Select Create.
In the Create Safety Investigation Event dialog, complete the following information:
- Name: Enter a Name for this Safety 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.
Select Save.