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 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:
Prerequisites
Consider the following prerequisites:
- Your Admin can configure your Vault to create Statistical Data records for the following data sources:
- To open FAERS and VAERS Case series in a dashboard and store Signal Calculations of different data sources in a single Statistical Data record, your Admin must enable multi-source signal data consolidation.
- To view advanced calculation errors in more detail, your Admin must add the Advanced Calculation Errors field to the Data section of the Statistical Data object layout.
- To create Statistical Data at the Aggregate Reporting Group level, your Admin must:
Create Statistical Data from Signal Calculation Runs
To create a Statistical Data record from a Signal Calculation Run:
- Navigate to the Run Calculations tab.
- Select a Signal Calculation Run record.
- 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 Signal Reporting Period.
When the Calculation on the Signal Calculation Run is set, 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 on the Signal Calculation Run is blank, the run executes all calculations associated with the Signal Calculations Setting and Vault creates:
- Statistical Data records using the following logic:
- If the Results Output on the Signal Calculations Setting is Multiple Records: A Statistical Data record for Signal Calculation results for each data source with an Output Type of Statistical Data Record or blank
- If the Results Output on the Signal Calculations Setting is Single Record: A Statistical Data record for Signal Calculation results with an Output Type of Statistical Data Record or blank. Vault includes all calculation scores for a PEC in a single Statistical Data record, regardless of the data source. For example, if calculations of the Safety and FAERS data source detect the same PEC, Vault includes these calculations in the same Statistical Data record.
- A CSV file for each Signal Calculation (either for each data source or including all data sources, depending on the Results Output) with an Output Type of CSV Attachment and where the Signal Calculation matches the created Statistical Data records on the following values:
- MedDRA Term or MedDRA Query
- Reporting period
- Source
- Product Family or Aggregate Reporting Group
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:
- Navigate to the Statistical Data tab.
- Select Create.
- Complete the applicable fields.
- 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.
Note: Each Statistical Data record must have a unique combination of:
- PEC Period
- Detection date
- Source
- Signal Source Data
- When configured, Subgroup (for example, Age Group) and Subgroup value (for example, Elderly)
Details
| Field | Description |
|---|---|
| Product-Event Combination | The unique Product-Event Combination (PEC). |
| PEC Period | The specific reporting period for a PEC. The PEC Period is also known as Product-Event Disposition. |
| Product Family | Vault maps the Product Family from the related PEC Period. This field is read-only. |
| Aggregate Reporting Group | Vault maps the Aggregate Reporting Group from the related PEC Period. |
| MedDRA Term | Vault maps the MedDRA Term for the detected adverse event from the PEC Period. This field is read-only. |
| MedDRA Query | The Standardised MedDRA Query (SMQ) or custom MedDRA Query (CMQ) that is being monitored. Vault maps the MedDRA Query from the PEC Period. 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 Signal Reporting Period from the Signal Calculation Run. |
| Detection Type | Select the type of analysis performed for this PEC. The options in the picklist are:
|
| 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:
|
| 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:
|
| 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. |
| Subgroup | The subgroup used for this Statistical Data. |
| Age Group | The age group used for subgrouping this Statistical Data. |
| Indication | The indication used for subgrouping this Statistical Data. |
| Receipt Year | The receipt year used for subgrouping this Statistical Data. |
| Region | The region used for subgrouping this Statistical Data. |
| Route of Admin | The route of administration used for subgrouping this Statistical Data. |
| Sex | The sex used for subgrouping this Statistical Data. |
Source
| Field | Description |
|---|---|
| Source | The source of the detected adverse event report. Vault populates this field with the Regulatory Database. If the Regulatory Database is blank, Vault populates this field with Safety Database. If the Results Output on the Signal Calculations Setting is Single Record, Vault leaves this field blank. 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 (for example, FAERS). If the Results Output on the Signal Calculations Setting is Single Record, Vault leaves this field blank. 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. |
| Calculation Data Sources | The Data Source used in the Signal Calculation. Vault populates this field using the following logic:
|
Data
For more information about the different types of calculations and scores, see Signal Detection Calculations.
| 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 (includes both postmarket spontaneous and study reports). |
| 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 score provides disproportionate reporting. |
| 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. |
| Advanced Calculation Errors | This field applies to Statistical Data records created manually or on a schedule from a Signal Calculation Run. If an advanced calculation failed to generate a score during the calculation run, Vault populates this field to indicate there was an advanced calculation error. If multiple advanced calculations failed (for example, EBGM and Information Component), Vault populates this field with all errors, separated by a semicolon (;). If the Create Statistical Data action is run (manually or on a schedule) from the Signal Calculation Run, Vault updates this field accordingly. |
| IC | The raw Information Component (IC) score (not calculated with the Bayesian shrinkage model). This score provides disproportionate reporting. |
| IC-Bayes | The IC score calculated using the Bayesian shrinkage model. |
| IC005 | The lower bound of the 99% IC confidence interval, representing the probability the value of the IC score is lower than the calculated value. |
| IC025 | The lower bound of the 95% IC confidence interval, representing the probability the value of the IC score is lower than the calculated value. |
| Prior Used | The prior distribution used in the IC-Bayes calculation. When you run an IC calculation, Vault refers to this field to calculate the IC-Bayes 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.
Open Signal Case Series in Workbench Dashboards
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:
- Navigate to Statistical Data > [Statistical Data].
- From the All Actions menu, select one of the following actions depending on the data source:
- Safety: Open Case Series in Workbench Dashboard
- FAERS: Open FAERS Case Series in Dashboard
- VAERS: Open VAERS Case Series in Dashboard
- In the dashboard, select the Filters (
) icon. - Enter the applicable filters and select Apply.
For the EVDAS data source, you cannot navigate to a Workbench Dashboard directly from a Statistical Data record. To open a dashboard for EVDAS data:
- Navigate to Workbench Dashboards > [Workbench Dashboard].
- Select the Filters icon.
- Select a Statistical Data ID from the Signal Case Series drop-down.
- Select Apply.
Note: To use Workbench Reports and Workbench Dashboards, you must obtain a Veeva Safety Workbench license.
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.