Signal Management

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

About Signal Management

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 (PEC) establishes a causal relationship between a product and an event as detected in a Signal. In Vault, PECs 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 record, navigate 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.

Create a Signal Reporting Period

You can create a Signal Reporting Period from a Product-Event Combination record or from the Reporting Periods tab. To create a reporting period from the tab:

  1. Navigate to the Reporting Periods tab.
  2. Select Create.
  3. Complete the following information:
    • Product Family: Select a Product Family from the drop-down or select the Advanced Search icon to use filters and refine your search.
    • Start Date: Use the calendar to select the Start Date or enter the date manually. Select Today to set the date to the current day.
    • End Date: Use the calendar to select the End Date or enter the date manually. Select Today to set the date to the current day.
    • Signal Product Profile: Select a Signal Product Profile from the drop-down or select the Advanced Search icon to use filters and refine your search.
  4. Select Save or Save + Create to save this record and create another.

Results

Vault creates a new Signal Reporting Period in the Initial state type.

The following sections appear in the Signal Reporting Period layout:

  • Statistical Data: This section is used in signal detection. When the reporting period becomes associated with a Statistical Data record, Vault adds the record to this section.
  • PEC Periods: Select Create to create a new PEC Period record and complete the fields. When the reporting period becomes associated with a PEC Period from a Product-Event Combination record, Vault adds the PEC Period to this section.

Signal Reporting Period Lifecycle States

After you create a Signal Reporting Period, Vault sets the lifecycle state type to Initial. You can use the Workflow and State Change (workflow state change) icon to set the reporting period to certain lifecycle states. Based on your Admin’s configuration, Vault may change the lifecycle state after certain processes. The following table describes the Signal Reporting Period lifecycle state types:

State Type Description
Initial The Signal Reporting Period is not yet processed.
Queued The Signal Reporting Period is ready for system processing. You must set the record to this state for it to be considered in the scheduled signal detection process.
System Processing The Signal Reporting Period is currently being processed by Vault in the scheduled signal detection process.
Ready The Signal Reporting Period is ready for signal review.

Vault sets this state type when the Signal Reporting Period is processed by scheduled signal detection or the Alert Rule Engine. Vault also sets this field for Signal Reporting Periods that skipped processing (does not have a linked Signal Product Profile or does not have calculations and alert rules configured).
Error The Signal Reporting Period resulted in an error during processing.
Complete Users can manually set the Signal Reporting Period to this state when system processing is complete.

PEC Periods Fields

As you assess a PEC, 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. You can also create PEC Periods from a Signal Reporting Period.

To create a PEC Period, navigate to the PEC Periods section of the related Product-Event Combination or Signal Reporting Period record and select Create. The following fields appear:

Field Description
Product-Event Combination If creating the PEC Period from a Product-Event Combination record, Vault populates this field with the associated PEC.

If creating the PEC Period from a Signal Reporting Period, select a Product-Event Combination from the drop-down or select the Advanced Search icon to use filters and refine your search.
Primary Product Family Vault populates this field using the PEC's Product Family.
Primary MedDRA Term Vault populates this field with the value selected in the Primary MedDRA Term field on the related Product-Event Combination record.
MedDRA Query Vault populates this field with the value selected in the MedDRA Query field on the related Product-Event Combination record.
Primary Product Family Vault populates this field with the value selected in the Primary Product Family field on the related Product-Event Combination record.
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 PEC was detected for investigation.
Use the calendar to select the date or enter the date manually.
Safety Investigation This field is for more detailed investigation and reporting. 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 Opening 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 Opening 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 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 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 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 fields in the table below appear on each Safety Investigation. If you do not see a field, your Admin may need to add it to the layout.

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.
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.

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.
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 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 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 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:

  1. Navigate to the Safety Investigations tab and select a Safety Investigation.
  2. In the Products section, select Create.
  3. 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.
  4. 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:

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 records)
  • 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 record and multiple Safety Investigation Product records 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

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.