Signal Detection Using PV Data

Learn how to use signal detection for PV data.

About PV Signal Detection

Pharmacovigilance (PV) data is transferred daily from Vault Safety to a Signal database. Vault Safety Signal can then perform signal detection for Product-Event Combinations (PECs) from Vault Safety Cases. Vault Safety is the only PV database that can be accessed by Vault Safety Signal.

Based on your Admin’s configured signal calculations, you can run calculations on all or a subset of PV data for specified reporting periods to detect PECs. You can also run ad-hoc calculations outside of a product’s reporting period and create records detailing the results of the calculations.

Using the signal calculation results, you can create Statistical Data records, which provide information about the PEC and Case counts. Vault creates a record for each new detected PEC, if any. When a Product-Event Combination requires further investigation as a potential signal, you can create a Safety Investigation from the respective Statistical Data record.

Prerequisites

To perform signal analysis on PV data, your Admin must:

Signal Calculations

Signal Calculation Run records specify the type of calculation you will run on all PV data in Safety Signal. Optionally, for a more specific output, you can add safety view filters to a record.

After running a signal calculation, you can preview the data or store the data in a Statistical Data record.

Run Signal Calculations

To calculate signal detection scores and preview the results for PV data:

  1. Navigate to the Run Calculations tab.
  2. Select a Signal Calculation Run record. The Calculations Setting and Calculation fields provide more detail about the calculation.
  3. Expand the Filters section and each filter group to provide filter values as needed and to apply additional filters.
  4. From the All Actions menu, select Calculate.
  5. Expand the Preview section and then select Preview.

Result

Vault displays a preview of all the results found to a maximum of 100 Cases. If you leave the page, the Preview section clears. To store the results of a signal calculation, create Statistical Data records.

Create Statistical Data

You can store the results of signal calculations in Statistical Data records.

To create a Statistical Data record from a Signal Calculation Run record:

  1. Navigate to the Run Calculations tab.
  2. Select a Signal Calculation Run record.
  3. From the All Actions menu, select Create Statistical Data.

Results: Statistical Data from Signal Calculation Runs

Vault creates a Statistical Data record for every PEC detected by the signal calculation. To see the list, navigate to the Statistical Data tab.

If Vault detects any new PECs, Vault creates a new Product-Event Combination record. You can see the existing list in the Product-Event Combinations tab. For each detected PEC, Vault creates a PEC Period record.

Optionally, you can also create a Statistical Data record from the Statistical Data tab:

  1. Navigate to the Statistical Data tab.
  2. Select Create.
  3. Use the Statistical Data Fields section to complete the Create Statistical Data page.
  4. Select Save.

Results: Statistical Data from Statistical Data Tab

A new Statistical Data record appears in the Statistical Data tab.

Statistical Data Fields

The following tables describe the fields on a Statistical Data record.

Details

Field Description
PEC Period The PEC Period is also known as Product-Event Disposition. This field identifies the specific reporting period for a PEC.
Product Family The Product Family being monitored.
Vault maps the Product Family field from the PEC Period record. This field is read-only.
MedDRA Term The MedDRA term and code for the detected adverse event.
Vault maps the MedDRA Term field from the PEC Period record. This field is read-only.
MedDRA Query The Standard MedDRA Query (SMQ) or Custom MedDRA Query (CMQ) that is being monitored.
Vault maps the MedDRA Query field from the PEC Period record. This field is read-only.
Detection Date The date Vault calculated the statistical data results. Vault sets this to the current date.

Use the calendar to select a date or enter a date manually.
Reporting Period The time period for the adverse events within the PEC Period.

Vault maps the Reporting Period field from the Signal Calculation Run record.
Detection Type Select the type of analysis performed for this PEC. The options in the picklist are:
  • Routine
  • Ad-Hoc
Detection Method The method used to create the Product-Event Combination record.
Vault sets this to Manual.
Alert Identifies whether the PEC meets the criteria for further investigation, based on your Admin's configured business rules.

Select Yes or No.
Listed Identifies whether the MedDRA Term is listed on the Family Datasheet for the primary Product Family. For more information on how Vault calculates this field, see Signal Detection Calculations.

Select Yes or No.
Current Disposition The outcome of this signal during the most recent PEC reporting period. The options are:
  • Monitor: Select this option if the signal needs to be further monitored before a decision can be made.
  • Inactive: Select this option to inactivate the signal.
Current Disposition Date The date the Current Disposition was set on the related Statistical Data record.
Previous Period Disposition The outcome of this signal during the previous PEC reporting period. The options are:
  • Monitor: Select this option if the signal needs to be further monitored before a decision can be made.
  • Inactive: Select this option to inactivate the signal.
Previous Period Disposition Date The date the Previous Period Disposition was set on the related Statistical Data record.
Safety Investigation This field is for PECs that require further evaluation and assessment.
To select an existing Safety Investigation, select the drop-down or select the Advanced Search icon to use filters and refine your search. To create a Safety Investigation, from the drop-down, select Create Safety Investigation. For more instructions, see Create Safety Investigations.
Vault links the created Safety Investigation record to this field.
Statistical Data Unique Name The unique ID for this record.

Source

Field Description
Source The source of the detected adverse event report.
Select a source 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.

Data

Field Description
New All The number of post-market PECs within the reporting period (includes both post-market spontaneous and study reports).
New Spontaneous The number of spontaneous PECs within the reporting period.
New Fatal The number of fatal PECs within the reporting period (includes both post-market spontaneous and study reports).
New Serious The number of serious PECs within the reporting period (includes both post-market spontaneous and study reports).
Cumulative All The number of post-market PECs up to and including the reporting period (includes both post-market spontaneous and study reports).
Cumulative Spontaneous The number of spontaneous PECs up to and including the reporting period.
Cumulative Fatal The number of fatal PECs up to and including the reporting period (includes both post-market spontaneous and study reports).
Cumulative Serious The number of serious PECs up to and including the reporting period (includes both post-market spontaneous and study reports).

Next Steps: Create Safety Investigations from Statistical Data Records

For confirmed Product-Event Combinations that require further investigation, you can create a Safety Investigation from the Statistical Data record.