# Generate Tabulations Using Aggregate Report Sections

Learn how to generate and manage tabulations at the Aggregate Report Section level.

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      <p><strong>Note</strong>: Depending on your Admin’s configuration, your Vault’s object, field, and section labels, lifecycle states, and workflows may differ from the general information in all articles. Refer to your organization’s business processes for guidance.</p>
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## About Generating Tabulations for Aggregate Report Authoring

You can generate tabulations for your aggregate reports in Safety. <a href="/en/lr/01124/">Generate Aggregate Report Tabulations</a> provides more information for generating and managing tabulations at the Aggregate Report level. At this level, the tables are added to the **Documents** section on each record. 

When authoring aggregate reports using Aggregate Report Sections, you can generate and manage tabulations individually at the Section level. This option gives you more granular control over the authoring process because tabulations can be generated or updated for specific areas of the report as needed.

Managing tabulations at the Aggregate Report level or managing them at the Aggregate Report Section level is determined by an Admin setting in your Vault.

The following sections provide more details.

## Prerequisites

Consider the following prerequisites for generating tabulations and managing them at the Aggregate Report Section level:

* Your Vault must be licensed for Veeva Safety to generate tabulations. Contact your Veeva representative for more information.
* Your Admin must <a href="/en/lr/681603/">enable Generating Tabulations Using Aggregate Report Sections</a>.
* Your Admin must <a href="/en/lr/681603/#enable-setting-to-generate-tabulations-using-sections">enable the Generate Tabulations Using Sections setting</a>. If this setting is not enabled, you can still generate tabulations at the Aggregate Report level.

## Generate Tabulations Using Sections
The following sections describe how to generate tabulations using Aggregate Report Sections:

<!--adding this reuse file because the Combine Tabulations and Authoring feature (23R3.4) is shared across Safety Management and SafetyDocs-->

### Select a Document to Generate

To tell Vault which tabulation documents to generate, create Aggregate Report Sections and complete the **Document to Generate** field using the following steps:

1. Go to an **Aggregate Report** record.
2. Create Aggregate Report Sections.
   * If you are <a href="/en/lr/680414/#automatically-generate-sections">automatically generating Sections</a> using a template and your Admin has set up the corresponding Template Item, Vault automatically creates a **Safety Tabulation** type Section with the **Document to Generate** field populated.
   * If you are <a href="/en/lr/680414/#manually-create-sections">manually creating Sections</a>, in the **Create Aggregate Report Section** dialog, select **Safety Tabulation**.
3. In the **Details** section, complete the **Document to Generate** field as follows and select **Save**:

<table>
   <thead>
       <tr>
           <th>Field</th>
           <th>Value</th>
       </tr>
   </thead>
   <tbody>
       <tr>
           <td>Document to Generate</td>
           <td>Select which tabulation document to generate from the dropdown.
           <p>
           The options that appear in the dropdown depend on the Aggregate Report Type.</p>
           <p>
           If this Section was auto-created from a template, Vault maps this field from the corresponding Template Item.</p></td>
       </tr>
   </tbody>
</table>

The following fields also appear on **Safety Tabulation** type Sections:

<table>
   <thead>
       <tr>
           <th>Field</th>
           <th>Value</th>
       </tr>
   </thead>
   <tbody>
       <tr>
           <td>Report Document (Masked)</td>
           <td>When you select the <a href="/en/lr/01128/">Generate Masked Documents option</a> on the parent <strong>Aggregate Report</strong> record, Vault links masked tabulation reports to this field.</td>
       </tr>
       <tr>
           <td>Report Document (Log)</td>
           <td>Vault creates a log file and links it to this field every time tabulations are generated.</td>
       </tr>
       <tr>
           <td>Tabulation Generation Date</td>
           <td>Vault populates this field with the date when tabulations are generated.</td>
       </tr>
   </tbody>
</table>

### Run the Generate Aggregate Report Tabulation Action

Once the _Document to Generate_ field has been populated, generate tabulations for a specific _Aggregate Report Section_ by going to the **All Actions** menu of that section and selecting **Generate Aggregate Report Tabulation**.

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      <p><strong>Note</strong>: The <em>Generate Aggregate Report Tabulation</em> action appears only for <em>Safety Tabulation</em> type sections.</p>
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When you initiate the action, Vault does the following:

* Generates tabulations based on the option selected in the _Document to Generate_ field.
* Links the generated tabulations to the _Report Document_ or _Report Document (Masked)_ field on the _Aggregate Report Section_.
* Creates a log file in the library and links it to the _Report Document (Log)_ field on the _Aggregate Report Section_.
* Populates the _Tabulation Generation Date_ field on the _Aggregate Report Section_.
* Identifies _Case_ records for traceability by generating an _Aggregate Report Case_ record for each _Case_ included in the report and updating the following:
  * The _Document_ for every ADR _Case_ within the _Summary Tabulation_. For Periodic Benefit-Risk Evaluation Reports (PBRERs), Vault sets the _Document_ to _Cumulative Tabulation of ADRs from Postmarketing Sources_. For all other reports, Vault populates _Interval Line Listings of Serious Adverse Reactions_.
  * The _Report Column_ for every ADR _Case_ within the _Summary Tabulation_. Vault clears this field.
* Populates the _List of Cases_ section with links to _Cases_ from the following interval reports for the applicable aggregate report:
  * **DSUR:** <a href="/en/lr/01280/#interval-line-listings-serious-ar">Interval Line Listings of Serious Adverse Reactions</a> for _Study Cases_
  * **PBRER:** <a href="/en/lr/01282/#interval-line-listings-serious-ar">Interval Line Listings of Serious Adverse Reactions (from Clinical Trials)</a> for _Study Cases_ and _Cumulative Tabulation of ADRs from Postmarketing Sources_
  * **PADER:** <a href="/en/lr/01281/#interval-line-listings">Interval Line Listings</a>
  * **PSUR:** <a href="/en/lr/01279/#cioms-ii-line-listing">CIOMS II Interval Line Listing of Adverse Drug Reactions</a>
  * **CIOMS II:** <a href="/en/lr/01279/#cioms-ii-line-listing">CIOMS II Interval Line Listing of Adverse Drug Reactions</a>
  * **PMDA Post-Market:**
    * <a href="/en/lr/674650/#nupr">NUPR Line Listing Form 7-2</a>
    * <a href="/en/lr/674650/#form-3">J-PSR Cumulative Tabulation of Adverse Events Form 3</a>
    * <a href="/en/lr/674650/#form-4">J-PSR Line Listing of Adverse Events Form 4</a>

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      <p><strong>Note</strong>: Vault supports a maximum of 20,000 <em>Cases</em> per aggregate report for PBRERs. <em>Case</em> listings are not generated for any other reports within the PBRER or DSUR.</p>
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To generate tabulations for multiple sections at once, navigate to the parent **Aggregate Report** record, and from the **All Actions** menu, select **Generate Aggregate Report Tabulations**. When the action is run from the parent _Aggregate Report_ record, Vault completes the actions above for all _Safety Tabulation_ type sections on that record.

### Update Generated Tabulations

To update these tabulation documents, you can run the **Generate Aggregate Report Tabulations** action again if your Aggregate Report Sections have not reached the **Complete** state. When the action is re-initiated, Vault regenerates the associated tabulations and upversions the linked documents with the new details. Related fields are also updated as required.



