# Create Statistical Data

You can store the results of <a href="/en/gr/935433/">_Signal Calculations_</a> in _Statistical Data_ records. These records provide information about <a href="/en/gr/896824/#create-pec">_Product-Event Combinations_ </a> (PECs) and _Case_ counts. If the _Signal Calculation_ is <a href="/en/gr/753144/#signal-view-field">associated with a safety view</a> 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 <a href="/en/gr/753144/#output-type-field">_Output Type_</a> on the _Signal Calculations_, you can store calculation results in either or both of the following outputs: 
* [_Statistical Data_][1]
* <a href="/en/gr/935433/#download">CSV files</a>

## Prerequisites {#prerequisite}

Consider the following prerequisites:
* Your Admin can configure your Vault to create _Statistical Data_ records for the following data sources:
    * <a href="/en/gr/935439/">FDA Adverse Event Reporting System (FAERS)</a>
    * <a href="/en/gr/1006100/">Vaccine Adverse Event Reporting System (VAERS)</a>
* 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 <a href="/en/gr/1005912/">multi-source signal data consolidation</a>.
* To view advanced calculation errors in more detail, your Admin must <a href="/en/gr/26387/#how-to-add-object-fields">add</a> 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:
    * <a href="/en/gr/1007527/">Enable Signal Calculations for Product Family Combinations</a>
    * <a href="/en/gr/1007532/">Configure Signal Calculations Settings for Aggregate Reporting Groups</a>

## Create Statistical Data from Signal Calculation Runs {#statistical-data-from-signal-calc-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 <a href="/en/gr/896824/#create-signal-reporting-period">_Signal Reporting Period_</a>.

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][3] 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 <a href="/en/gr/753144/#create-signal-calculations-settings">_Signal Calculations Setting_</a> 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_][4], if selected on the _Signal Calculation_. Vault does not support _Signal Case Series_ for _Signal Calculations_ associated with a <a href="/en/gr/753144/#signal-view-field">safety view at the MedDRA query level</a>.

## Create Statistical Data from Statistical Data Tab {#statistical-data-from-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][3].
4. Select **Save**.

**Results**

A new _Statistical Data_ record appears in the _Statistical Data_ tab.

## Statistical Data Fields {#statistical-data-fields}

The following tables describe the fields on a _Statistical Data_ record. 

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: Each <em>Statistical Data</em> record must have a unique combination of:</p>
<ul>
  <li><em>PEC Period</em></li>
  <li>Detection date</li>
  <li><em>Source</em></li>
  <li><em>Signal Source Data</em></li>
  <li>When <a href="/en/gr/753144/#create-signal-calculations">configured</a>, <em>Subgroup</em> (for example, <em>Age Group</em>) and <em>Subgroup</em> value (for example, <em>Elderly</em>)</li>
</ul>
    </div>
  </div>
</div>



#### Details

<table>
    <thead>
          <tr>
               <th><strong>Field</strong></th>
               <th><strong>Description</strong></th>
          </tr>
    </thead>
    <tbody>
          <tr>
               <td><em>Product-Event Combination</em></td>
               <td>The unique <em>Product-Event Combination</em> (PEC).</td>
          </tr>
          <tr>
               <td><em>PEC Period</em></td>
               <td>The specific reporting period for a PEC. The <em>PEC Period</em> is also known as <em>Product-Event Disposition</em>.</td>
          </tr>
          <tr>
               <td><em>Product Family</em></td>
               <td>Vault maps the <em>Product Family</em> from the related <em>PEC Period</em>. This field is read-only.</td>
          </tr>
          <tr>
               <td><em>Aggregate Reporting Group</em></td>
               <td>Vault maps the <em>Aggregate Reporting Group</em> from the related <em>PEC Period</em>.</td>
          </tr>
          <tr>
               <td><em>MedDRA Term</em></td>
               <td>Vault populates the <a href="/en/gr/896824/#meddra-term"><em>MedDRA Term</em></a> for the detected adverse event from the <em>PEC Period</em>. This field is read-only.</td>
          </tr>
          <tr>
               <td><em>MedDRA Query</em></td>
               <td>The <a href="/en/gr/01189/">Standardised MedDRA Query (SMQ) or custom <em>MedDRA Query</em> (CMQ)</a> that is being monitored. Vault maps the <em>MedDRA Query</em> from the <em>PEC Period</em>. This field is read-only.</td>
          </tr>
          <tr>
               <td><em>Detection Date</em></td>
               <td>The date Vault calculated the <em>Statistical Data</em> results. Vault populates this field with the current date.
                    <p>Use the calendar to select a date or enter a date manually.</p></td>
          </tr>
          <tr>
               <td><em>Reporting Period</em></td>
               <td>The time period for the adverse events within the <em>PEC Period</em>.
                    <p>Vault maps the <em>Signal Reporting Period</em> from the <em>Signal Calculation Run</em>.</p>
               </td>
          </tr>
          <tr>
               <td id="detection-type"><em>Detection Type</em></td>
               <td>Select the type of analysis performed for this PEC. The options in the picklist are:
                    <ul>  
                        <li><em>Routine</em></li>
                        <li><em>Ad-Hoc</em></li>
                    </ul>
                </td>
          </tr>
          <tr>
               <td id="detection-method"><em>Detection Method</em></td>
               <td>The method used to create the <em>Product-Event Combination</em> record. When Vault creates the <em>Statistical Data</em> record as part of a <a href="/en/gr/826975/">scheduled run</a>, Vault populates this field with <em>Auto</em>. Otherwise, Vault populates this field with <em>Manual</em>.</td>
          </tr>
          <tr>
               <td><em>Alert</em></td>
               <td>Identifies whether the PEC meets the criteria for further investigation, based on your Admin's configured business rules. 
                    <p>Select <strong>Yes</strong> or <strong>No</strong>.</p></td>
          </tr>
          <tr>
               <td><em>Listed</em></td>
               <td>Identifies whether the <em>MedDRA Term</em> is listed on the <em>Product Datasheet</em>. For more information on how Vault calculates this field, see <a href="/en/gr/752951/#listedness">Signal Detection Calculations</a>.
                    <p>Select <strong>Yes</strong> or <strong>No</strong>.</p></td>
          </tr>
          <tr>
               <td><em>Current Disposition</em></td>
               <td>The outcome of this PEC during the most recent PEC reporting period. The options are: 
                    <ul>
                        <li><strong>Review Required</strong>: Select this option if the PEC requires review, for example, if the <em>Alert</em> column is set to <em>Yes</em>.</li>
                        <li><strong>Review Not Required</strong>: Select this option if the PEC does not require review, for example, if the <em>Alert</em> column is set to <em>No</em>.</li>
                        <li><strong>Create Safety Investigation</strong>: Select this option if the PEC is considered a potential signal and requires further validation and evaluation.</li>
                        <li><strong>Monitor</strong>: Select this option if the PEC needs to be further monitored before a decision can be made.</li>
                        <li><strong>Inactive</strong>: Select this option to inactivate the PEC.</li>
                    </ul></td>
          </tr>
          <tr>
               <td><em>Current Disposition Date</em></td>
               <td>The date the <em>Current Disposition</em> was set on the related <em>Statistical Data</em> record.</td>
          </tr>
          <tr>
               <td><em>Previous Period Disposition</em></td>
               <td>The outcome of this PEC during the previous PEC reporting period. The options are: 
                    <ul>
                        <li><strong>Review Required</strong>: Select this option if the PEC requires review, for example, if the <em>Alert</em> column is set to <em>Yes</em>.</li>
                        <li><strong>Review Not Required</strong>: Select this option if the PEC does not require review, for example, if the <em>Alert</em> column is set to <em>No</em>.</li>
                        <li><strong>Create Safety Investigation</strong>: Select this option if the PEC is considered a potential signal and requires further validation and evaluation.</li>
                        <li><strong>Monitor</strong>: Select this option if the PEC needs to be further monitored before a decision can be made.</li>
                        <li><strong>Inactive</strong>: Select this option to inactivate the PEC.</li>
                    </ul></td>
          </tr>
          <tr>
               <td><em>Previous Period Disposition Date</em></td>
               <td>The date the <em>Previous Period Disposition</em> was set on the related <em>Statistical Data</em> record.</td>
          </tr>
          <tr>
               <td><a id="statistical-data-safety-investigation-field"></a><em>Safety Investigation</em></td>
               <td>This field is for PECs that require further evaluation and assessment.<br>
                    To select an existing <em>Safety Investigation</em>, select the drop-down or select the <strong>Advanced Search</strong> icon to use filters and refine your search. To create a <em>Safety Investigation</em>, from the drop-down, select <strong>Create Safety Investigation</strong>. For more instructions, see <a href="/en/gr/752958/#create-a-safety-investigation-from-statistical-data">Create Safety Investigations</a>.<br>
                    Vault links the created <em>Safety Investigation</em> record to this field.</td>
          </tr>
          <tr>
               <td><em>Statistical Data Unique Name</em></td>
               <td>The unique ID for this record.</td>
          </tr>
          <tr>
               <td><em>Signal Product Profile</em></td>
               <td>A <em>Signal Product Profile</em> defines a <em>Product Family</em> and the parameters used in signal detection. Vault populates this field when the <em>Statistical Data</em> record is created by the <a href="/en/gr/826975/">scheduled <em>Signal Calculations</em> and alerts job</a>.</td>
          </tr>
         <tr>
               <td><em>Subgroup</em></td>
               <td>The subgroup used for this <em>Statistical Data</em>.</td>
          </tr>
         <tr>
               <td><em>Age Group</em></td>
               <td>The age group used for subgrouping this <em>Statistical Data</em>.</td>
          </tr>
         <tr>
               <td><em>Indication</em></td>
               <td>The indication used for subgrouping this <em>Statistical Data</em>.</td>
          </tr>
         <tr>
               <td><em>Receipt Year</em></td>
               <td>The receipt year used for subgrouping this <em>Statistical Data</em>.</td>
          </tr>
         <tr>
               <td><em>Region</em></td>
               <td>The region used for subgrouping this <em>Statistical Data</em>.</td>
          </tr>
         <tr>
               <td><em>Route of Admin</em></td>
               <td>The route of administration used for subgrouping this <em>Statistical Data</em>.</td>
          </tr>
         <tr>
               <td><em>Sex</em></td>
               <td>The sex used for subgrouping this <em>Statistical Data</em>.</td>
          </tr>
    </tbody>
</table>

#### Source

<table>
    <thead>
          <tr>
               <th><strong>Field</strong></th>
               <th><strong>Description</strong></th>
          </tr>
    </thead>
    <tbody>
          <tr>
               <td><em>Source</em></td>
               <td>The source of the detected adverse event report. Vault populates this field with the <em>Regulatory Database</em>. If the <em>Regulatory Database</em> is blank, Vault populates this field with <em>Safety Database</em>. If the <em>Results Output</em> on the <a href="/en/gr/753144/#create-signal-calculations-settings"><em>Signal Calculations Setting</em></a> is <em>Single Record</em>, Vault leaves this field blank. When the <a href="#detection-method"><em>Detection Method</em></a> is manual, select a <strong>Source</strong> from the drop-down or select the <strong>Advanced Search</strong> icon to use filters and refine your search.</td>
          </tr>
          <tr>
               <td><em>Signal Source Data</em></td>
               <td>The data source through which Vault detected the PEC for monitoring (for example, FAERS). If the <em>Results Output</em> on the <em>Signal Calculations Setting</em> is <em>Single Record</em>, Vault leaves this field blank. When the <a href="#detection-method"><em>Detection Method</em></a> is manual, select a <strong>Signal Source Data</strong> from the drop-down or select the <strong>Advanced Search</strong> icon to use filters and refine your search.</td>
          </tr>
         <tr>
               <td><em>Calculation Data Sources</em></td>
               <td>The <em>Data Source</em> used in the <em>Signal Calculation</em>. Vault populates this field using the following logic: 
                    <ul>
                        <li>If the <em>Results Output</em> on the <em>Signal Calculations Setting</em> is <em>Multiple Records</em>: 
                            <ul>
                                <li>If the <em>Data Source</em> on the <em>Signal Calculation</em> is blank, Vault populates <code>Safety Data</code>.</li>
                                <li>If the <em>Data Source</em> is set, Vault populates the respective data source.</li>
                            </ul>
                        </li>
                        <li>If the <em>Results Output</em> on the <em>Signal Calculations Setting</em> is <em>Single Record</em>, Vault populates this field with all the calculation data sources included in the <em>Signal Calculations Setting</em> separated by a comma (for example, <code>FAERS, Safety Data, VAERS</code>).</li>
                    </ul>
                </td>
          </tr>
    </tbody>
</table>

#### Data

For more information about the different types of calculations and scores, see <a href="/en/gr/752951/">Signal Detection Calculations</a>.

<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>New All</em></td>
            <td>The number of unique, postmarket <em>Cases</em> in which the PEC occurred within the reporting period (includes postmarket spontaneous reports).</td>
        </tr>
        <tr>
            <td><em>New Spontaneous</em></td>
            <td>The number of unique, spontaneous <em>Cases</em> in which the PEC occurred within the reporting period (includes postmarket spontaneous reports).</td>
        </tr>
        <tr>
            <td><em>New Fatal</em></td>
            <td>The number of unique, fatal <em>Cases</em> in which the PEC occurred within the reporting period (includes postmarket spontaneous reports).</td>
        </tr>
        <tr>
            <td><em>New Serious</em></td>
            <td>The number of unique, serious <em>Cases</em> in which the PEC occurred within the reporting period (includes postmarket spontaneous reports).</td>
        </tr>
        <tr>
            <td><em>Cumulative All</em></td>
            <td>The number of unique, postmarket <em>Cases</em> in which the PEC occurred up to and including the reporting period (includes postmarket spontaneous reports).</td>
        </tr>
        <tr>
            <td><em>Cumulative Spontaneous</em></td>
            <td>The number of unique, spontaneous <em>Cases</em> in which the PEC occurred up to and including the reporting period (includes postmarket spontaneous reports).</td>
        </tr>
        <tr>
            <td><em>Cumulative Fatal</em></td>
            <td>The number of unique, fatal <em>Cases</em> in which the PEC occurred up to and including the reporting period (includes postmarket spontaneous reports).</td>
        </tr>
        <tr>
            <td><em>Cumulative Serious</em></td>
            <td>The number of unique, serious <em>Cases</em> in which the PEC occurred up to and including the reporting period (includes postmarket spontaneous reports).</td>
        </tr>
        <tr>
            <td><em>EBGM</em></td>
            <td>The Empirical Bayes Geometric Mean (EBGM) score. This score provides <a href="/en/gr/752951/#disproportionality">disproportionate reporting</a>.</td>
        </tr>
        <tr>
            <td><em>EB05</em></td>
            <td>The lower bound EBGM score. This score represents the probability that the value of the EBGM score is lower than the calculated value.</td>
        </tr>
       <tr>
            <td><em>EB95</em></td>
            <td>The upper bound EBGM score. This score represents the probability that the value of the EBGM score is greater than the calculated value.</td>
        </tr>
      <tr>
            <td><a id="advanced-calculation-errors"></a><em>Advanced Calculation Errors</em></td>
            <td><p>This field applies to <em>Statistical Data</em> records created manually or on a schedule from a <em>Signal Calculation Run</em>. If an advanced calculation failed to generate a score <a href="/en/gr/935433/#advanced-calculation">during the calculation run</a>, 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 (;).</p>
            <p>If the <em>Create Statistical Data</em> action is run (manually or on a schedule) from the <em>Signal Calculation Run</em>, Vault updates this field accordingly.</p>    
            </td>
        </tr>
      <tr>
            <td><em>IC</em></td>
            <td>The raw <a href="/en/gr/752951/#ic">Information Component (IC)</a> score (not calculated with the Bayesian shrinkage model). This score provides <a href="/en/gr/752951/#disproportionality">disproportionate reporting</a>. </td>
        </tr>
     <tr>
            <td><em>IC-Bayes</em></td>
            <td>The IC score calculated using the <a href="/en/gr/752951/#ebgm">Bayesian shrinkage model</a>.</td>
        </tr>
     <tr>
            <td><em>IC005</em></td>
            <td>The lower bound of the 99% IC confidence interval, representing the probability the value of the IC score is lower than the calculated value. </td>
        </tr>
     <tr>
            <td><em>IC025</em></td>
            <td>The lower bound of the 95% IC confidence interval, representing the probability the value of the IC score is lower than the calculated value. </td>
        </tr>
     <tr>
            <td><em>Prior Used</em></td>
            <td>The prior distribution used in the <em>IC-Bayes</em> calculation. When you run an IC calculation, Vault refers to this field to calculate the <em>IC-Bayes</em> value.</td>
        </tr>
    </tbody>
</table>

### Signal Case Series {#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 <a href="/en/gr/753144/#signal-view-field">safety view at the MedDRA query level</a>.

#### Open Signal Case Series in Workbench Dashboards

To further analyze and visualize _Signal Case Series_ data, you can use <a href="/en/gr/752963/#case-series">_Workbench Reports_</a> and <a href="/en/gr/831712/#case-series">_Workbench Dashboards_</a>. To navigate to a _Workbench Dashboard_ directly from a _Signal Case Series_:
1. Navigate to **Statistical Data > [Statistical Data]**. 
2. 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**
3. In the dashboard, select the **Filters** (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-workbench-filter-icon.png" alt="filter icon" style="" />) icon.
4. 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: 
1. Navigate to **Workbench Dashboards > [Workbench Dashboard]**.
2. Select the **Filters** icon.
3. Select a _Statistical Data_ ID from the _Signal Case Series_ drop-down.
4. Select **Apply**.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: To use <em>Workbench Reports</em> and <em>Workbench Dashboards</em>, you must obtain a <a href="/en/gr/752926/">Veeva Safety Workbench</a> license.</p>
    </div>
  </div>
</div>



## Next Steps: Create Safety Investigations from Statistical Data Records

For confirmed _Product-Event Combinations_ that require further investigation, you can <a href="/en/gr/752958/#create-a-safety-investigation-from-statistical-data">create a <em>Safety Investigation</em></a> from the _Statistical Data_ record.

[1]: #statistical-data-from-signal-calc-runs
[2]: #statistical-data-from-tab
[3]: #statistical-data-fields
[4]: #signal-case-series