Signal Management | Vault Help

Learn how to track the Signal Management process in your Vault.

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 Signal Management

Vault SafetyDocs now supports the Signal Management process based on GVP Module IX guidelines. According to GVP Module IX, Signal Management should be completed in the following order:

A Signal is detected through a Signal Detection process or Literature Reviews.
The Signal is assessed and its validity is determined.
If the Signal is valid, an investigation is performed by reviewing all available data from Cases and Inbox Items.
Based on the investigation outcome, the Signal is either confirmed or refuted.
If the Signal is confirmed, further actions are taken such as putting the related product on a watchlist or creating a risk management plan and submitting it to a regulatory authority.

Signal Management in SafetyDocs provides the ability to track Signals after detection and progress through the steps above while maintaining accurate Signal-related records. This feature’s capabilities include:

Tracking emerging Signals as Product-Event Combinations
Setting Product-Event Dispositions on these Combinations
Documenting details and verdicts of Safety Investigations
Linking Product-Event Combinations and Dispositions to Safety Investigations

The following sections provide more details about Signal Management.

Prerequisites

Your Admin must configure your Vault to use the features described on this page. The following pages provide more information:

Working with Signal Documents

When uploading Signal-related documents, use the Signal Management document type. This includes the following subtypes and classifications:

Signal Management > Signal Product-Event > Product-Event Disposition
Signal Management > Signal Investigation > Investigation Summary
Signal Management > Signal Investigation > Investigation Materials

Upload Signal Management documents using the same process as for other document types. For more information, see Adding Documents.

Create a Product-Event Combination

A Product-Event Combination establishes a causal relationship between a product and an event as detected in a Signal. In Vault, Product-Event Combinations are made up of the Primary Product Family of the suspected product and the primary MedDRA term or query for the reported event.

To create a Product-Event Combination, go to the Product-Event Combinations tab in your Vault and select Create. The following fields appear:

Field	Description
Primary Product Family	The Product Family that is being monitored. Select a Product Family from the dropdown or select the Advanced Search icon to use filters and refine your search.
Primary MedDRA Term	The MedDRA code for the symptom or adverse event that is being monitored. This can be anywhere in the MedDRA Hierarchy. Select a term from the dropdown or select the Advanced Search icon to use filters and refine your search. You must specify a value for either the Primary MedDRA Term field or the MedDRA Query field.
MedDRA Query	The standard or custom MedDRA query that is being monitored. Select a query from the dropdown or select the Advanced Search icon to use filters and refine your search. You must specify a value for either the Primary MedDRA Term field or the MedDRA Query field.
Most Recent Disposition	When the most recent Product-Event Disposition enters the Complete state, Vault populates this field with the value entered in the Final Disposition field of that Product-Event Disposition.
Most Recent Disposition Date	When the most recent Product-Event Disposition enters the Complete state, Vault populates this field with the value entered in the Final Disposition Date field of that Product-Event Disposition.

Save the page to finish creating the record.

Product-Event Dispositions Section

As you assess a Product-Event Combination, you can create Product-Event Dispositions to track details about your assessment and record whether the Signal is confirmed, refuted, inactive, or needs to be monitored at that point in time. Additionally, you can create a Safety Investigation directly from Product-Event Dispositions for detailed investigation and reporting.

To create a Product-Event Disposition, go to the Product-Event Dispositions section of the related Product-Event Combination and select Create. The following fields appear:

Field	Description
Primary MedDRA Term	Vault populates this field with the value selected in the Primary MedDRA Term field on the related Product-Event Combination.
MedDRA Query	Vault populates this field with the value selected in the MedDRA Query field on the related Product-Event Combination.
Primary Product Family	Vault populates this field with the value selected in the Primary Product Family field on the related Product-Event Combination.
Reporting Period	The time period being monitored for events related to this Product-Event Disposition. Select a Reporting Period from the dropdown or select the Advanced Search icon to use filters and refine your search. Alternatively, select Create Signal Reporting Period from the dropdown and manually enter the start and end dates of the Reporting Period.
Detection Date	The date when the related Product-Event Combination was detected for investigation. Use the calendar to select the date or enter the date manually.
Safety Investigation	If this Product-Event Disposition led to a Safety Investigation, select this investigation from the dropdown or select the Advanced Search icon to use filters and refine your search. Alternatively, select Create Safety Investigation from the dropdown and complete the fields as detailed in the Create a Safety Investigation section below.
Investigation Type	Select the investigation type for this Product-Event Disposition review. The available options in the picklist include: Routine Ad-Hoc
Primary Source	The reporting source through which the signal was detected for monitoring. Select a Primary Source from the dropdown or select the Advanced Search icon to use filters and refine your search.
Final Disposition	Select the final disposition for the chosen Reporting Period from the picklist. The available options include: Confirmed Refuted Monitor Inactive
Final Disposition Date	The date when the Final Disposition was set. Use the calendar to select the date or enter the date manually.

Save the page to finish creating the record.

Note: To support hierarchical browsing of MedDRA Terms for Product-Event Combinations and Product-Event Dispositions, we recommend making some criteria VQL updates in your Vault. Contact your Admin to enable MedDRA UI Enhancements for Non-Case Coding.

Create a Safety Investigation

Creating a Safety Investigation allows you to record details such as the Reporting Period of events you are investigating, important dates, and Final Dispositions. You can also specify the outcome of your investigation and provide details about relevant data, which is useful for auditing and compliance purposes.

To create a Safety Investigation, go to the Safety Investigations tab in your Vault and select Create. Complete the fields as needed and select Save.

Alternatively, if your Admin has enabled Create Safety Investigations from Product-Event Dispositions, you can also create a Safety Investigation in the following ways:

To create a Safety Investigation from a single Product-Event Disposition, go to the related Product-Event Disposition record, and from the All Actions menu, select Open Investigation.
To create a Safety Investigation from multiple Product-Event Dispositions, complete the following steps:
1. From the Reporting Periods tab, select a Reporting Period record.
2. In the Product-Event Dispositions section, select Show in Tab.
3. On the All Product-Event Dispositions page, select Perform Bulk Actions > All records from the All Actions menu.
4. On the Refine Selection page, select the records from which you want to create the Safety Investigation and select Next.
5. On the Choose Action page, select Record Actions > Next.
6. On the Choose Record Action page, select Open Investigation from Dispositions > Next.
7. Review the information on the Confirmation page and select Finish.

Result

A Safety Investigation is created. Field values in the Safety Investigation are mapped from the Product-Event Disposition from which it was created. If it was created from multiple Product-Event Dispositions, Vault maps field values from the first record selected.

The following fields appear on each Safety Investigation:

Field	Description
Product Family	The Product Family that is being monitored in this investigation. Select a Product Family from the dropdown or select the Advanced Search icon to use filters and refine your search. When you create a Safety Investigation from a Product-Event Disposition, Vault maps this value from the Product-Event Disposition.
Primary Source	The reporting source through which the signal was detected for monitoring. Select a Primary Source from the dropdown or select the Advanced Search icon to use filters and refine your search. When you create a Safety Investigation from a Product-Event Disposition, Vault maps this value from the Product-Event Disposition.
Detection Date	The date when the related Product-Event Combination was detected for investigation. Use the calendar to select the date or enter the date manually. When you create a Safety Investigation from a Product-Event Disposition, Vault maps this value from the Product-Event Disposition.
Start Date	The date when this investigation was started. Use the calendar to select the date or enter the date manually. When you create a Safety Investigation from a Product-Event Disposition, Vault sets this field to the date of creation.
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.
Validation Outcome	Select whether this investigation led to the detected Signal being confirmed. The available options in the picklist include: Validated Non-Validated
Validation Outcome Date	The date when the Validation Outcome was set on this investigation. Vault automatically sets this to the current date whenever the Validation Outcome field is updated.
Final Disposition	The final outcome of the Safety investigation. The available options include: Confirmed Refuted Monitor Inactive
Final Disposition Date	The date when the Final Disposition was set on the related Product-Event Disposition. Vault automatically sets this to the current date whenever the Final Disposition field is updated.
Priority	Select the priority of the Safety Investigation. The available options in the picklist include: Critical High Medium Low

Save the page to finish creating the record.