Create Statistical Data

You can store the results of Signal Calculations in Statistical Data records. These records provide information about Product-Event Combinations (PECs) and Case counts. If the Signal Calculation is associated with a safety view that returns results at the Product Family-MedDRA query level, the Statistical Data you create from the calculation will also be at the MedDRA query level, as opposed to at the MedDRA Preferred Term (PT) level.

Depending on the Output Type on the Signal Calculations, you can store calculation results in either or both of the following outputs: 

Prerequisite

To create Statistical Data records for the FAERS data source, your Admin must configure calculations and Statistical Data creation.

Create Statistical Data from Signal Calculation Runs

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

  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

If Vault detects any new PECs, Vault creates corresponding Product-Event Combination records. View the list in the Product-Event Combinations tab. For each detected PEC, Vault creates a PEC Period for the associated Reporting Period.

Vault creates a Statistical Data record for every PEC detected by the Signal Calculation and populates the fields using the Signal Calculation results. View the list in the Statistical Data tab. When the Calculation field on the Signal Calculation Run is blank and the run executed all calculations associated with the Signal Calculations Setting, Vault creates:

  • A Statistical Data record for each Signal Calculation with an Output Type of Statistical Data Record or blank
  • A CSV file for each Signal Calculation with an Output Type of CSV Attachment and where the Signal Calculation matches the created Statistical Data records on the following values:
    • MedDRA query
    • Reporting period 
    • Source 
    • Product Family
      Vault attaches each CSV in the Attachments section of the first matching Statistical Data record.

Vault also creates a Signal Case Series, if selected on the Signal Calculation. Vault does not support Signal Case Series for Signal Calculations associated with a safety view at the MedDRA query level.

Create Statistical Data from Statistical Data Tab

To create a Statistical Data record from the Statistical Data tab:

  1. Navigate to the Statistical Data tab.
  2. Select Create.
  3. Complete the applicable fields.
  4. Select Save.

Results

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
Product-Event Combination The unique Product-Event Combination (PEC) record.
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 populates this field with 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. When Vault creates the Statistical Data record as part of a scheduled run, Vault populates this field with Auto. Otherwise, Vault populates this field with 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 Product Datasheet. For more information on how Vault calculates this field, see Signal Detection Calculations.

Select Yes or No.
Current Disposition The outcome of this PEC during the most recent PEC reporting period. The options are:
  • Review Required: Select this option if the PEC requires review, for example, if the Alert column is set to Yes.
  • Review Not Required: Select this option if the PEC does not require review, for example, if the Alert column is set to No.
  • Create Safety Investigation: Select this option if the PEC is considered a potential signal and requires further validation and evaluation.
  • Monitor: Select this option if the PEC needs to be further monitored before a decision can be made.
  • Inactive: Select this option to inactivate the PEC.
Current Disposition Date The date the Current Disposition was set on the related Statistical Data record.
Previous Period Disposition The outcome of this PEC during the previous PEC reporting period. The options are:
  • Review Required: Select this option if the PEC requires review, for example, if the Alert column is set to Yes.
  • Review Not Required: Select this option if the PEC does not require review, for example, if the Alert column is set to No.
  • Create Safety Investigation: Select this option if the PEC is considered a potential signal and requires further validation and evaluation.
  • Monitor: Select this option if the PEC needs to be further monitored before a decision can be made.
  • Inactive: Select this option to inactivate the PEC.
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.
Signal Product Profile A Signal Product Profile defines a Product Family and the parameters used in signal detection. Vault populates this field when the Statistical Data record is created by the scheduled Signal Calculations and alerts job.

Source

Field Description
Source The source of the detected adverse event report. Vault populates this field with the Health Authority Database. If the Health Authority Database is blank, Vault populates this field with Safety Database. When the Detection Method is manual, select a Source from the drop-down or select the Advanced Search icon to use filters and refine your search.
Signal Source Data The data source through which Vault detected the PEC for monitoring. Vault populates the Data Source on the Signal Calculation. When the Detection Method is manual, select a Signal Source Data 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 unique, postmarket Cases in which the PEC occurred within the reporting period (includes both postmarket spontaneous and study reports).
New Spontaneous The number of unique, spontaneous Cases in which the PEC occurred within the reporting period.
New Fatal The number of unique, fatal Cases in which the PEC occurred within the reporting period (includes both postmarket spontaneous and study reports).
New Serious The number of unique, serious Cases in which the PEC occurred within the reporting period (includes both postmarket spontaneous and study reports).
Cumulative All The number of unique, postmarket Cases in which the PEC occurred up to and including the reporting period (includes both postmarket spontaneous and study reports).
Cumulative Spontaneous The number of unique, spontaneous Cases in which the PEC occurred up to and including the reporting period.
Cumulative Fatal The number of unique, fatal Cases in which the PEC occurred up to and including the reporting period (includes both postmarket spontaneous and study reports).
Cumulative Serious The number of unique, serious Cases in which the PEC occurred up to and including the reporting period (includes both postmarket spontaneous and study reports).
EBGM The Empirical Bayes Geometric Mean (EBGM) score. This disproportionality score estimates the rate of an adverse event occurring for a particular Product within a specific database.
EB05 The lower bound EBGM score. This score represents the probability that the value of the EBGM score is lower than the calculated value.
EB95 The upper bound EBGM score. This score represents the probability that the value of the EBGM score is greater than the calculated value.

Signal Case Series

A Signal Case Series is a static set of Case versions. This list keeps the data set consistent for signal analysis for all collaborating users and does not change over time.

When you create a new Statistical Data record by running a Signal Calculation set to execute Signal Case Series, Vault creates a new Signal Case Series. When you run the Signal Calculation again with the same Reporting Period, Vault updates the Signal Case Series to reflect the latest calculation run. If you update the Reporting Period and run the calculation, Vault creates a new Signal Case Series. Case series creation applies only to Statistical Data records that were created using a Signal Calculation set to execute Signal Case Series. Vault does not support Signal Case Series for Signal Calculations associated with a safety view at the MedDRA query level.

To further analyze and visualize Signal Case Series data, you can use Workbench Reports and Workbench Dashboards. To navigate to a Workbench Dashboard directly from a Signal Case Series, in the Statistical Data record, select the All Actions menu and then select Open Case Series in Workbench Dashboard.

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.