The signal detection process detects Product-Event Combinations (PECs) at the Product Family-MedDRA Preferred Term (PT) level. If required, you can set up your Vault to detect PECs at the Product Family-MedDRA Query level and identify signal events for a group of MedDRA terms.
Note: Vault supports detection at the MedDRA Query level for Safety data only.
Depending on your business needs, configure your Vault for Signal Calculations to return case counts and Empirical Bayes Geometric Mean (EBGM) scores:
- Scenario A: At the Preferred Term (PT) level and MedDRA Query level for a given Product Family
- Scenario B: At the MedDRA Query level for a given Product Family, with PTs included in the MedDRA Query in CSV format
- Scenario C: At the MedDRA Query level for a given Product Family, with PTs included in the MedDRA Query in Statistical Data records
Prerequisites
Before configuring your Vault to return results at the MedDRA Query level, you must enable Signal Calculations for MedDRA Queries.
Scenario A: Identify MedDRA Terms and MedDRA Queries in Statistical Data Records
In this example scenario, you are configuring your Vault to identify MedDRA terms and MedDRA Queries and generate Statistical Data records according to the following parameters:
- The Output Type for all calculations is Statistical Data Record (or blank).
- Standard MedDRA Queries (SMQs) include:
- Accidents and injuries
- Asthma/bronchospasm
- The Product Family is Cholecap.
To do this:
- Create a Signal Product Profile with the following information:
- Name: Enter
Cholecap. - Product Family: Select Cholecap from the drop-down.
- Source: Select Safety Database from the drop-down.
- Organization: Select the appropriate Organization.
- Name: Enter
- Populate the Alert Rule Sets section to specify the rules a PEC must meet to qualify as a potential signal.
- Create a Signal Reporting Period with the following information:
- Product Family: Select Cholecap from the drop-down.
- Start Date: Use the calendar to select a start date or enter the date manually.
- End Date: Use the calendar to select an end date or enter the date manually.
- Signal Product Profile: Select Cholecap from the drop-down.
- Review Type: Select Ad-Hoc from the drop-down.
- Copy the pharmacovigilance (PV) Signal Views provided by Veeva as indicated so that you can modify the new custom views according to your business needs.
- Create a Signal Calculations Setting with the name
Cholecap Calculations Setting. - Create Signal Calculations for this Signal Calculations Setting as indicated.
- Navigate to the Signal Product Profile you created and in the Calculations Setting field, select Cholecap Calculations Setting from the drop-down.
After a user runs the Signal Calculations and creates Statistical Data, Vault generates the specified results.
Signal Views Table
The following table displays the Signal Views you must copy and rename:
| Signal View to Copy | New Custom Signal View Name |
|---|---|
| [New Counts-PT-level view] | New Counts (PT) |
| [Cumulative Counts-PT-level view] | Cumulative Counts (PT) |
| [EBGM Counts-PT-level view] | EBGM Counts (PT) |
| [New Counts-MedDRA Query-level view] | New Counts MedDRA Query |
| [Cumulative Counts-MedDRA Query-level view] | Cumulative Counts MedDRA Query |
| [EBGM Counts-MedDRA Query-level view] | EBGM Counts MedDRA Query |
Signal Calculations Table
The following table displays the Signal Calculations you must create:
| Signal Calculation to Create | Query Type | Calculation | Output Type | Signal View | Filter |
|---|---|---|---|---|---|
| PT level | SQL | N/A | Statistical Data Record (or blank) | New Counts (PT) | N/A |
| PT level | SQL | N/A | Statistical Data Record (or blank) | Cumulative Counts (PT) | N/A |
| PT level | Advanced | EBGM | Statistical Data Record (or blank) | EBGM Counts (PT) | N/A |
| MedDRA Query level (Accidents and injuries) | SQL | N/A | Statistical Data Record (or blank) | New Counts MedDRA Query | MedDRA Query ID > Accidents and injuries |
| MedDRA Query level (Accidents and injuries) | SQL | N/A | Statistical Data Record (or blank) | Cumulative Counts MedDRA Query | MedDRA Query ID > Accidents and injuries |
| MedDRA Query level (Accidents and injuries) | Advanced | EBGM | Statistical Data Record (or blank) | EBGM Counts MedDRA Query | MedDRA Query ID > Accidents and injuries |
| MedDRA Query level (Asthma/bronchospasm) | SQL | N/A | Statistical Data Record (or blank) | New Counts MedDRA Query | MedDRA Query ID > Asthma/bronchospasm |
| MedDRA Query level (Asthma/bronchospasm) | SQL | N/A | Statistical Data Record (or blank) | Cumulative Counts MedDRA Query | MedDRA Query ID > Asthma/bronchospasm |
| MedDRA Query level (Asthma/bronchospasm) | Advanced | EBGM | Statistical Data Record (or blank) | EBGM Counts MedDRA Query | MedDRA Query ID > Asthma/bronchospasm |
As the PT-level views in this scenario are not associated with a MedDRA Query, you do not need to specify a MedDRA Query filter value for the PT-level calculations.
Results
For the PT-level Signal Calculations, as each of these calculations has an Output Type of Statistical Data Record (or blank), Vault creates a Statistical Data record for each new detected Product Family-PT combination. The following table lists the results in each PT-level Statistical Data record:
| Statistical Data Record ID | Product Family | MedDRA Term | MedDRA Query | New Counts (Spontaneous) | Cumulative Counts (Spontaneous) | New Counts (Fatal) | Cumulative Counts (Fatal) | EBGM |
|---|---|---|---|---|---|---|---|---|
| SD-0001 | Cholecap | Accident at work | [Blank] | 3 | 19 | 0 | 1 | 1.12 |
| SD-0002 | Cholecap | Animal Bite | [Blank] | 4 | 8 | 0 | 0 | 0.89 |
| SD-0003 | Cholecap | Back Injury | [Blank] | 5 | 20 | 0 | 0 | 1.45 |
| SD-0004 | Cholecap | Asthma exercise induced | [Blank] | 1 | 20 | 0 | 0 | 1.02 |
| SD-0005 | Cholecap | Hyperventilation | [Blank] | 0 | 5 | 0 | 0 | 0.95 |
| SD-0006 | Cholecap | Wheezing | [Blank] | 2 | 10 | 0 | 0 | 1.28 |
| SD-0007 | Cholecap | Arthritis | [Blank] | 2 | 4 | 0 | 0 | 0.74 |
| SD-0008 | Cholecap | Nausea | [Blank] | 3 | 10 | 0 | 0 | 1.10 |
| SD-0009 | Cholecap | Rash | [Blank] | 10 | 30 | 0 | 0 | 1.05 |
The Signal Calculations Setting in this scenario includes three PT-level Signal Calculations (new counts, cumulative counts, and EBGM counts). Vault returns detected PTs that exist for the given Product Family (Cholecap). Some of the MedDRA terms returned by the PT-level calculations are also associated with the following MedDRA Queries:
- Accidents and injuries:
- Accident at work
- Animal Bite
- Back Injury
- Asthma/bronchospasm:
- Asthma exercise induced
- Hyperventilation
- Wheezing
The Arthritis, Nausea, and Rash PTs are not associated with either of the selected MedDRA Query values. To identify PTs only from a given MedDRA Query, see scenarios B and C.
For the MedDRA Query-level Signal Calculations, as each of these calculations has an Output Type of Statistical Data Record (or blank), Vault creates a Statistical Data record for each Product Family-MedDRA Query combination. The following table lists the results in each MedDRA Query-level Statistical Data record:
| Statistical Data Record ID | Product Family | MedDRA Term | MedDRA Query | New Counts (Spontaneous) | Cumulative Counts (Spontaneous) | New Counts (Fatal) | Cumulative Counts (Fatal) | EBGM |
|---|---|---|---|---|---|---|---|---|
| SD-0010 | Cholecap | [Blank] | Accidents and injuries | 12 | 47 | 0 | 1 | 1.30 |
| SD-0011 | Cholecap | [Blank] | Asthma/bronchospasm | 3 | 35 | 0 | 0 | 1.24 |
The Signal Calculations Setting in this scenario includes six MedDRA Query-level Signal Calculations (new counts, cumulative counts, and EBGM counts for each MedDRA Query).
Scenario B: Identify Preferred Terms for a MedDRA Query in CSV Format
In this example scenario, you are configuring your Vault to identify MedDRA Queries and MedDRA terms within those queries and generate the respective output according to the following parameters:
- The Output Types are:
- For MedDRA Query-level calculations: Statistical Data Record (or blank)
- For PT-level calculations: CSV Attachment
- Standard MedDRA Queries (SMQs) include:
- Accidents and injuries
- Asthma/bronchospasm
- The Product Family is Cholecap.
To do this:
- Create a Signal Product Profile with the following information:
- Name: Enter
Cholecap. - Product Family: Select Cholecap from the drop-down.
- Source: Select Safety Database from the drop-down.
- Organization: Select the appropriate Organization.
- Name: Enter
- Populate the Alert Rule Sets section to specify the rules a PEC must meet to qualify as a potential signal.
- Create a Signal Reporting Period with the following information:
- Product Family: Select Cholecap from the drop-down.
- Start Date: Use the calendar to select a start date or enter the date manually.
- End Date: Use the calendar to select an end date or enter the date manually.
- Signal Product Profile: Select Cholecap from the drop-down.
- Review Type: Select Ad-Hoc from the drop-down.
- Copy the pharmacovigilance (PV) Signal Views provided by Veeva as indicated so that you can modify the new custom views according to your business needs.
- Create a Signal Calculations Setting with the name
Cholecap Calculations Setting. - Create Signal Calculations for this Signal Calculations Setting as indicated.
- Navigate to the Signal Product Profile you created and in the Calculations Setting field, select Cholecap Calculations Setting from the drop-down.
After a user runs the Signal Calculations and creates Statistical Data, Vault generates the specified results.
Signal Views Table
The following table displays the Signal Views you must copy and rename:
| Signal View to Copy | New Custom Signal View Name |
|---|---|
| [New Counts-MedDRA Query-level view] | New Counts MedDRA Query |
| [New Counts-MedDRA Query-PT-level view] This view returns new case counts of detected PTs for the Product Family that are included in the given MedDRA Query. |
New Counts MedDRA Query (PT) |
| [Cumulative Counts-MedDRA Query-level view] | Cumulative Counts MedDRA Query |
| [Cumulative Counts-MedDRA Query-PT-level view] This view returns cumulative case counts of detected PTs for the Product Family that are included in the given MedDRA Query. |
Cumulative Counts MedDRA Query (PT) |
| [EBGM Counts-MedDRA Query-level view] | EBGM Counts MedDRA Query |
| [EBGM Counts-MedDRA Query-PT-level view] This view returns EBGM case counts of detected PTs for the Product Family that are included in the given MedDRA Query. |
EBGM Counts MedDRA Query (PT) |
Signal Calculations Table
The following table displays the Signal Calculations you must create:
| Signal Calculation to Create | Query Type | Calculation | Output Type | Signal View | Filter |
|---|---|---|---|---|---|
| MedDRA Query level (Accidents and injuries) | SQL | N/A | Statistical Data Record (or blank) | New Counts MedDRA Query | MedDRA Query ID > Accidents and injuries |
| PT level (Accidents and injuries) | SQL | N/A | CSV Attachment | New Counts MedDRA Query (PT) | MedDRA Query ID > Accidents and injuries |
| MedDRA Query level (Accidents and injuries) | SQL | N/A | Statistical Data Record (or blank) | Cumulative Counts MedDRA Query | MedDRA Query ID > Accidents and injuries |
| PT level (Accidents and injuries) | SQL | N/A | CSV Attachment | Cumulative Counts MedDRA Query (PT) | MedDRA Query ID > Accidents and injuries |
| MedDRA Query level (Accidents and injuries) | Advanced | EBGM | Statistical Data Record (or blank) | EBGM Counts MedDRA Query | MedDRA Query ID > Accidents and injuries |
| PT level (Accidents and injuries) | Advanced | EBGM | CSV Attachment | EBGM Counts MedDRA Query (PT) | MedDRA Query ID > Accidents and injuries |
| MedDRA Query level (Asthma/bronchospasm) | SQL | N/A | Statistical Data Record (or blank) | New Counts MedDRA Query | MedDRA Query ID > Asthma/bronchospasm |
| PT level (Asthma/bronchospasm) | SQL | N/A | CSV Attachment | New Counts MedDRA Query (PT) | MedDRA Query ID > Asthma/bronchospasm |
| MedDRA Query level (Asthma/bronchospasm) | SQL | N/A | Statistical Data Record (or blank) | Cumulative Counts MedDRA Query | MedDRA Query ID > Asthma/bronchospasm |
| PT level (Asthma/bronchospasm) | SQL | N/A | CSV Attachment | Cumulative Counts MedDRA Query (PT) | MedDRA Query ID > Asthma/bronchospasm |
| MedDRA Query level (Asthma/bronchospasm) | Advanced | EBGM | Statistical Data Record (or blank) | EBGM Counts MedDRA Query | MedDRA Query ID > Asthma/bronchospasm |
| PT level (Asthma/bronchospasm) | Advanced | EBGM | CSV Attachment | EBGM Counts MedDRA Query (PT) | MedDRA Query ID > Asthma/bronchospasm |
As all PT-level views are associated with a MedDRA Query in this scenario, you must specify a MedDRA Query filter value for the PT-level calculations as well.
Results
For the MedDRA Query-level Signal Calculations, as each of these calculations has an Output Type of Statistical Data Record (or blank), Vault creates a Statistical Data record for each Product Family-MedDRA Query combination. The following table lists the results in a MedDRA Query-level Statistical Data record:
| Statistical Data Record ID | Product Family | MedDRA Term | MedDRA Query | New Counts (Spontaneous) | Cumulative Counts (Spontaneous) | New Counts (Fatal) | Cumulative Counts (Fatal) | EBGM |
|---|---|---|---|---|---|---|---|---|
| SD-0001 | Cholecap | [Blank] | Accidents and injuries | 12 | 47 | 0 | 1 | 1.30 |
| SD-0002 | Cholecap | [Blank] | Asthma/bronchospasm | 3 | 35 | 0 | 0 | 1.24 |
The Signal Calculations Setting in this scenario includes six MedDRA Query-level Signal Calculations (new counts, cumulative counts, and EBGM counts for each MedDRA Query).
For the PT-level Signal Calculations, as each of these calculations has an Output Type of CSV Attachment, Vault attaches a CSV to the first Statistical Data record matching on the following:
- Product Family (Cholecap)
- MedDRA Query (Accidents and injuries or Asthma/bronchospasm)
- Signal Reporting Period
- Source (Safety Database)
Each CSV lists new detected Product Family-PT combinations, where the PTs also belong to the respective MedDRA Query. The following table lists the results in each PT-level CSV attachment:
| CSV Attachment | Attached to | Product Family | MedDRA Term | MedDRA Query | New Counts (Spontaneous) | Cumulative Counts (Spontaneous) | New Counts (Fatal) | Cumulative Counts (Fatal) | EBGM |
|---|---|---|---|---|---|---|---|---|---|
| calculation_result_SCALC-0001 | SD-0001 | Cholecap | Accident at work | [Blank] | 3 | 19 | 0 | 1 | 1.12 |
| Cholecap | Animal Bite | [Blank] | 4 | 8 | 0 | 0 | 0.89 | ||
| Cholecap | Back Injury | [Blank] | 5 | 20 | 0 | 0 | 1.45 | ||
| calculation_result_SCALC-0002 | SD-0002 | Cholecap | Asthma exercise induced | [Blank] | 1 | 20 | 0 | 0 | 1.02 |
| Cholecap | Hyperventilation | [Blank] | 0 | 5 | 0 | 0 | 0.95 | ||
| Cholecap | Wheezing | [Blank] | 2 | 10 | 0 | 0 | 1.28 |
The Signal Calculations Setting in this scenario includes six PT-level Signal Calculations (new counts, cumulative counts, and EBGM counts for each MedDRA Query). Vault returns detected PTs that exist for the given Product Family-MedDRA Query combinations. In this scenario, Vault returns PTs for the following MedDRA Queries:
- Accidents and injuries:
- Accident at work
- Animal Bite
- Back Injury
- Asthma/bronchospasm:
- Asthma exercise induced
- Hyperventilation
- Wheezing
Scenario C: Identify Preferred Terms for a MedDRA Query in Statistical Data Records
In this example scenario, you are configuring your Vault to identify MedDRA Queries and MedDRA terms within those queries and generate Statistical Data records according to the following parameters:
- The Output Type for all calculations is Statistical Data Record (or blank).
- Standard MedDRA Queries (SMQs) include:
- Accidents and injuries
- Asthma/bronchospasm
- The Product Family is Cholecap.
To do this:
- Create a Signal Product Profile with the following information:
- Name: Enter
Cholecap. - Product Family: Select Cholecap from the drop-down.
- Source: Select Safety Database from the drop-down.
- Organization: Select the appropriate Organization.
- Name: Enter
- Populate the Alert Rule Sets section to specify the rules a PEC must meet to qualify as a potential signal.
- Create a Signal Reporting Period with the following information:
- Product Family: Select Cholecap from the drop-down.
- Start Date: Use the calendar to select a start date or enter the date manually.
- End Date: Use the calendar to select an end date or enter the date manually.
- Signal Product Profile: Select Cholecap from the drop-down.
- Review Type: Select Ad-Hoc from the drop-down.
- Copy the pharmacovigilance (PV) Signal Views provided by Veeva as indicated so that you can modify the new custom views according to your business needs.
- Create a Signal Calculations Setting with the name
Cholecap Calculations Setting. - Create Signal Calculations for this Signal Calculations Setting as indicated.
- Navigate to the Signal Product Profile you created and in the Calculations Setting field, select Cholecap Calculations Setting from the drop-down.
After a user runs the Signal Calculations and creates Statistical Data, Vault generates the specified results.
Signal Views Table
The following table displays the Signal Views you must copy and rename:
| Signal View to Copy | New Custom Signal View Name |
|---|---|
| [New Counts-MedDRA Query-level view] | New Counts MedDRA Query |
| [New Counts-MedDRA Query-PT-level view] This view returns new case counts of detected PTs for the Product Family that are included in the given MedDRA Query. |
New Counts MedDRA Query (PT) |
| [Cumulative Counts-MedDRA Query-level view] | Cumulative Counts MedDRA Query |
| [Cumulative Counts-MedDRA Query-PT-level view] This view returns cumulative case counts of detected PTs for the Product Family that are included in the given MedDRA Query. |
Cumulative Counts MedDRA Query (PT) |
| [EBGM Counts-MedDRA Query-level view] | EBGM Counts MedDRA Query |
| [EBGM Counts-MedDRA Query-PT-level view] This view returns EBGM case counts of detected PTs for the Product Family that are included in the given MedDRA Query. |
EBGM Counts MedDRA Query (PT) |
Signal Calculations Table
The following table displays the Signal Calculations you must create:
| Signal Calculation to Create | Query Type | Calculation | Output Type | Signal View | Filter |
|---|---|---|---|---|---|
| MedDRA Query level (Accidents and injuries) | SQL | N/A | Statistical Data Record (or blank) | New Counts MedDRA Query | MedDRA Query ID > Accidents and injuries |
| PT level (Accidents and injuries) | SQL | N/A | Statistical Data Record (or blank) | New Counts MedDRA Query (PT) | MedDRA Query ID > Accidents and injuries |
| MedDRA Query level (Accidents and injuries) | SQL | N/A | Statistical Data Record (or blank) | Cumulative Counts MedDRA Query | MedDRA Query ID > Accidents and injuries |
| PT level (Accidents and injuries) | SQL | N/A | Statistical Data Record (or blank) | Cumulative Counts MedDRA Query (PT) | MedDRA Query ID > Accidents and injuries |
| MedDRA Query level (Accidents and injuries) | Advanced | EBGM | Statistical Data Record (or blank) | EBGM Counts MedDRA Query | MedDRA Query ID > Accidents and injuries |
| PT level (Accidents and injuries) | Advanced | EBGM | Statistical Data Record (or blank) | EBGM Counts MedDRA Query (PT) | MedDRA Query ID > Accidents and injuries |
| MedDRA Query level (Asthma/bronchospasm) | SQL | N/A | Statistical Data Record (or blank) | New Counts MedDRA Query | MedDRA Query ID > Asthma/bronchospasm |
| PT level (Asthma/bronchospasm) | SQL | N/A | Statistical Data Record (or blank) | New Counts MedDRA Query (PT) | MedDRA Query ID > Asthma/bronchospasm |
| MedDRA Query level (Asthma/bronchospasm) | SQL | N/A | Statistical Data Record (or blank) | Cumulative Counts MedDRA Query | MedDRA Query ID > Asthma/bronchospasm |
| PT level (Asthma/bronchospasm) | SQL | N/A | Statistical Data Record (or blank) | Cumulative Counts MedDRA Query (PT) | MedDRA Query ID > Asthma/bronchospasm |
| MedDRA Query level (Asthma/bronchospasm) | Advanced | EBGM | Statistical Data Record (or blank) | EBGM Counts MedDRA Query | MedDRA Query ID > Asthma/bronchospasm |
| PT level (Asthma/bronchospasm) | Advanced | EBGM | Statistical Data Record (or blank) | EBGM Counts MedDRA Query (PT) | MedDRA Query ID > Asthma/bronchospasm |
As all PT-level views are associated with a MedDRA Query in this scenario, you must specify a MedDRA Query filter value for the PT-level calculations as well.
Results
For the PT-level Signal Calculations, as each of these calculations has an Output Type of Statistical Data Record (or blank), Vault creates a Statistical Data record for each new detected Product Family-PT combination, where the PTs also belong to the respective MedDRA Query. The following table lists the results in each PT-level Statistical Data record:
| Statistical Data Record ID | Product Family | MedDRA Term | MedDRA Query | New Counts (Spontaneous) | Cumulative Counts (Spontaneous) | New Counts (Fatal) | Cumulative Counts (Fatal) | EBGM |
|---|---|---|---|---|---|---|---|---|
| SD-0001 | Cholecap | Accident at work | [Blank] | 3 | 19 | 0 | 1 | 1.12 |
| SD-0002 | Cholecap | Animal Bite | [Blank] | 4 | 8 | 0 | 0 | 0.89 |
| SD-0003 | Cholecap | Back Injury | [Blank] | 5 | 20 | 0 | 0 | 1.45 |
| SD-0004 | Cholecap | Asthma exercise induced | [Blank] | 1 | 20 | 0 | 0 | 1.02 |
| SD-0005 | Cholecap | Hyperventilation | [Blank] | 0 | 5 | 0 | 0 | 0.95 |
| SD-0006 | Cholecap | Wheezing | [Blank] | 2 | 10 | 0 | 0 | 1.28 |
The Signal Calculations Setting in this scenario includes six PT-level Signal Calculations (new counts, cumulative counts, and EBGM counts for each MedDRA Query). Vault returns detected PTs that exist for the given Product Family-MedDRA Query combinations. In this scenario, Vault returns PTs for the following MedDRA Queries:
- Accidents and injuries:
- Accident at work
- Animal Bite
- Back Injury
- Asthma/bronchospasm:
- Asthma exercise induced
- Hyperventilation
- Wheezing
For the MedDRA Query-level Signal Calculations, as each of these calculations has an Output Type of Statistical Data Record (or blank), Vault creates a Statistical Data record for each Product Family-MedDRA Query combination. The following table lists the results in each MedDRA Query-level Statistical Data record:
| Statistical Data Record ID | Product Family | MedDRA Term | MedDRA Query | New Counts (Spontaneous) | Cumulative Counts (Spontaneous) | New Counts (Fatal) | Cumulative Counts (Fatal) | EBGM |
|---|---|---|---|---|---|---|---|---|
| SD-0007 | Cholecap | [Blank] | Accidents and injuries | 12 | 47 | 0 | 1 | 1.30 |
| SD-0008 | Cholecap | [Blank] | Asthma/bronchospasm | 3 | 35 | 0 | 0 | 1.24 |
The Signal Calculations Setting in this scenario includes six MedDRA Query-level Signal Calculations (new counts, cumulative counts, and EBGM counts for each MedDRA Query).