Create and Track Product-Event Combinations

A Product-Event Combination (PEC) establishes a relationship between a product and an event of disproportionate reporting to help track product-related safety issues. PECs are made up of the primary Product Family of the product of interest or an Aggregate Reporting Group that combines multiple Product Families and the primary MedDRA term or query for the reported event.

This article describes how to:

Create a Product-Event Combination.
Create a Signal Reporting Period.
Create PEC Periods.

Prerequisites

To code PECs to standard MedDRA Queries (SMQs) and custom MedDRA Queries (CMQs), your Admin must enable Coding Product-Event Combinations to MedDRA Queries.

To create PECs, PEC Periods, and Signal Reporting Periods at the Aggregate Reporting Group level, your Admin must:

Create a Product-Event Combination

To create a Product-Event Combination:

Navigate to the Product-Event Combinations tab.
Select Create.
Complete the applicable fields.
Select Save.

Product-Event Combination Fields

The following fields may be available:

Field	Description
Primary Product Family	Select the Product Family that is being monitored from the drop-down or select the Advanced Search () icon to use filters and refine your search. You must specify either a Primary Product Family or an Aggregate Reporting Group.
Aggregate Reporting Group	Select the Aggregate Reporting Group that is being monitored from the drop-down or select the Advanced Search icon to use filters and refine your search. You must specify either a Primary Product Family or an Aggregate Reporting Group.
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. For PECs created by Vault, Vault populates this field using the following logic: Vault uses the MedDRA term version that is active in the MedDRA dictionary. For example, if the MedDRA dictionary's active version is 28.0, Vault looks for the MedDRA term of version 28.0. When the MedDRA Version of a Case is out of sync with the dictionary version and the term does not exist in the active version, Vault looks for the term in the respective version available, which may result in populating a deprecated term.
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 the value entered in the Final Disposition field of that PEC Period. You cannot edit this field.
Most Recent Disposition Date	When the most recent PEC Period enters the Complete state, Vault populates the value entered in the Final Disposition Date field of that PEC Period. You cannot edit this field.

Create a Signal Reporting Period

Note: You can create a Signal Reporting Period from the PEC Periods section of a Product-Event Combination or from the Reporting Periods tab.

To create a Signal Reporting Period:

Navigate to the Reporting Periods tab.
Select Create.
Complete the applicable fields.
Select Save or Save + Create to save this record and create another.

Vault creates a new Signal Reporting Period in the Initial state type. The PEC Periods section appears in the Signal Reporting Period layout. When the Signal Reporting Period becomes associated with a PEC Period from a Product-Event Combination, Vault adds the PEC Period to this section.

Signal Reporting Period Fields

The following fields may be available:

Fields	Description
Product Family	Select the Product Family to which this time period applies from the drop-down or select the Advanced Search () icon to use filters and refine your search. You must specify either a Product Family or an Aggregate Reporting Group.
Aggregate Reporting Group	Select the Aggregate Reporting Group to which this time period applies from the drop-down or select the Advanced Search icon to use filters and refine your search. You must specify either a Product Family or an Aggregate Reporting Group.
Start Date	Use the calendar to select the start date or enter the date manually.
End Date	Use the calendar to select the end date or enter the date manually.
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.

Create PEC Periods

As you assess a PEC, you can create PEC Periods to track details about your assessment and record whether the signal requires a Safety Investigation, is inactive, or needs to be monitored at that point in time.

To create a PEC Period:

Navigate to the Product-Event Combinations or Reporting Periods tab and select a record.
Expand the PEC Periods section.
Select Create.
Complete the applicable fields.
Select Save.

PEC Period Fields

The following fields may be available:

Field	Description
Product-Event Combination	If creating the PEC Period from a Product-Event Combination, Vault populates the Product-Event Combination. 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 the Product Family from the related Product-Event Combination.
Aggregate Reporting Group	If creating the PEC Period from a Product-Event Combination, Vault populates the Aggregate Reporting Group from the related Product-Event Combination. If creating the PEC Period from a Signal Reporting Period, select an Aggregate Reporting Group from the drop-down or select the Advanced Search icon to use filters and refine your search.
Primary MedDRA Term	Vault populates the Primary MedDRA Term on the related Product-Event Combination.
MedDRA Query	Vault populates the MedDRA Query on the related Product-Event Combination.
Reporting Period	The time period being monitored for the event related to this PEC Period. If creating the PEC Period from a Signal Reporting Period, Vault populates the associated Signal Reporting Period. If creating the PEC Period from a Product-Event Combination, select a Signal 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 Signal Reporting Period. Note: Each reporting period must have a unique PEC 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.
Investigation Type	Select the investigation type for this PEC Period review.
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 from the drop-down for the chosen reporting period.
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.

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