Signal Management

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

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:

  1. A Signal is detected through a Signal Detection process or Literature Reviews.
  2. The Signal is assessed and its validity is determined.
  3. If the Signal is valid, an investigation is performed by reviewing all available data from Cases and Inbox Items.
  4. Based on the investigation outcome, the Signal is either confirmed or refuted.
  5. 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:

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 > PEC Period
  • 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 drop-down 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 drop-down 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 drop-down 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 PEC Period enters the Complete state, Vault populates this field with the value entered in the Final Disposition field of that PEC Period.
Most Recent Disposition Date When the most recent PEC Period enters the Complete state, Vault populates this field with the value entered in the Final Disposition Date field of that PEC Period.

Save the page to finish creating the record.

PEC Periods Section

As you assess a Product-Event Combination, you can create PEC Periods 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 PEC Periods for detailed investigation and reporting.

To create a PEC Period, go to the PEC Periods 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 the event related to this PEC Period.
Select a Reporting Period from the drop-down or select the Advanced Search icon to use filters and refine your search.

Alternatively, select Create Signal Reporting Period from the drop-down 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 PEC Period led to a Safety Investigation, select this investigation from the drop-down or select the Advanced Search icon to use filters and refine your search.

Alternatively, select Create Safety Investigation from the drop-down and complete the fields as detailed in the Safety Investigation Fields section below.
Investigation Type Select the investigation type for this PEC Period review.
The available options in the picklist include:
  • Routine
  • Ad-Hoc
Primary Source The reporting source through which Vault detected the signal for monitoring.
Select a Primary Source from the drop-down 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:
  • 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.
Literature Database The literature data source through which Vault detected the signal for monitoring.
Select a Literature Database from the drop-down or 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 monitoring.
Select a Health Authority Database from the drop-down or select the Advanced Search icon to use filters and refine your search.

Save the page to finish creating the record.

About Safety Investigations from PEC Periods

Creating a Safety Investigation allows you to record details such as the 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.

Create a Safety Investigation from PEC Periods

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 PEC Periods, you can also create a Safety Investigation in the following ways:

  • To create a Safety Investigation from a single PEC Period, go to the related PEC Period record, and from the All Actions menu, select Open Investigation.
  • To create a Safety Investigation from multiple PEC Periods, complete the following steps:
    1. From the Reporting Periods tab, select a Reporting Period record.
    2. In the PEC Periods section, select Show in Tab.
    3. On the All PEC Periods 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 PEC Period from which it was created. If it was created from multiple PEC Periods, Vault maps field values from the first record selected.

About Safety Investigations from Literature Articles

You can process signals as literature data from Literature Articles for analysis as part of your signal management process.

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. Vault also creates a Literature Data record linking the Literature Article and the Safety Investigation.

When there are multiple company product families 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.

In a scenario with multiple company product families where the Investigation Review Outcome is only provided for the primary Product Family (other product families have outcome left blank) 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 Product-Event Combination (PEC), identified signals can be linked to a reporting period.

For information on uploading literature documents and creating Literature Article records, see Manage the Literature Review Process.

Prerequisites

Before you can create a Safety Investigation from a Literature Article, your Admin must enable the following:

Depending on your business needs, optional capabilities are available for configuration.

Create a Safety Investigation from Literature Articles

To create a Safety Investigation from a Literature Article:

  1. Navigate to the Literature Article tab.
  2. From the All Actions menu next to the related Literature Article record, select Open Investigation.

Result

A Safety Investigation is created. Field values in the Safety Investigation are mapped from the Literature Article from which it was created.

Safety Investigation Fields

The following fields appear on each Safety Investigation:

Field Description
Description Enter a description for this investigation.
This field supports up to 150 characters.
Product Family The Product Family that is being monitored in this investigation.
Select a Product Family from the drop-down or select the Advanced Search icon to use filters and refine your search.
When you create a Safety Investigation from a PEC Period, Vault maps this value from the PEC Period.
Primary Source The reporting source through which Vault detected the signal for evaluation.
Select a Primary Source from the drop-down or select the Advanced Search icon to use filters and refine your search.
When you create a Safety Investigation from a PEC Period, Vault maps this value from the PEC Period.
Literature Database The literature data source through which Vault detected the signal for evaluation.
Select a Literature Database from the drop-down or select the Advanced Search icon to use filters and refine your search.
When you create a Safety Investigation from a PEC Period, Vault maps this value from the PEC Period.
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.
When you create a Safety Investigation from a PEC Period, Vault maps this value from the PEC Period.
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 PEC Period, Vault sets this field to the date of creation.
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 PEC Period, Vault maps this value from the PEC Period.
Priority Select the priority of the Safety Investigation. The available options in the picklist 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 options in the picklist are:
  • 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 options are:
  • Confirmed
  • Refuted
  • Monitor
  • Inactive
Final Disposition Date The date when the Final Disposition was set on the Safety Investigation.
Vault automatically 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.

Save the page to finish creating the record.

Add a MedDRA Term or MedDRA Query to a Safety Investigation

If configured by your Admin, you can add either a MedDRA Term or MedDRA Query directly on a Safety Investigation. To do this:

  1. On the Safety Investigation record, expand the Events section.
  2. Select Create.
  3. In the Create Safety Investigation Event window, 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.
  4. Select Save.