# Manage Case and Safety Report Collections

Vault enables you to organize groups of <a href="/en/lr/01301/#case-number">_Case Numbers_</a> into collections for reporting to partners, relevant health authorities, and other non-submission reporting requirements within your organization. You define the subset of _Cases_ within a collection by filtering on state, date ranges, products, or other case details. When you create a _Case Collection_, you specify the reporting format required, which can be any of the following:

* CIOMS I Masked
* CIOMS I Unmasked
* ICH E2B(R3)

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      <p><strong>Note</strong>: <em>Case Collections</em> support only the global CIOMS I form, not the CIOMS I (Chinese) form.</p>
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When a _Case Collection_ is ready for review or reporting, you can generate safety reports for all of the _Case Numbers_ in the specified format through the _Generate Document Collection_ action. You can select whether to generate safety reports for only the latest or for each selected _Case_ version. Vault exports all forms to a <a href="/en/lr/857974/">binder</a> and updates are version-controlled.

The same _Cases_ can be added to multiple _Case Collections_ if needed for different reports or in different formats.

## Prerequisite

Your Admin must <a href="/en/lr/680214/#case-number">enable Create and Export Case and Safety Report Collections</a>.

## Create a Case Collection

To group _Case Numbers_ for exporting to a specified format:

1. Navigate to the **Cases** tab and use <a href="/en/lr/442/#smart-filter">filters</a> to list the _Cases_ you want to include in the collection.
2. From the **All Actions** menu, under _Perform Bulk Action_, select **All [n] records**.
3. On the _Refine Selection_ page, clear checkboxes for any _Cases_ you don't want to include in the collection, and then select **Next**.
4. On the _Choose Action (Step 2)_ page, under _Manage Records_, select **Record Actions** and then select **Next**.
5. On the _Choose Record Action (Step 3)_ page, select an action and then select **Next**. The available record actions are as follows:
    * **Generate CIOMS I Unmasked Collection**
    * **Generate CIOMS I Masked Collection**
    * **Generate E2B R3 Collection**
6. On the _Summary_ page, select **Finish**.

**Result**

When the _Case Collection_ is ready, Vault sends an email and notification. The notice includes the number of _Case Numbers_ successfully added to the _Case Collection_, as well as the number that failed to generate if applicable. If the _Case Collection_ includes multiple _Case_ versions with the same _Case Number_, Vault generates a _Case Number_ for each version. In the email, select the success or failure link to download a CSV file with _Case Number_ details.

## Manage Case Collections

Navigate to **Business Admin (Quick Access) > Case Collections** to view all _Case Collections_. Select a _Case Collection_ to view or edit the _Case Collection_ details, generate or access the associated binder, and manage _Case Numbers_ in the collection.

### Case Collection Details Fields

<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Collection Name</td>
            <td>Vault populates a name for the <em>Case Collection</em>.</td>
        </tr>
        <tr>
            <td>Collection Title</td>
            <td>Select <strong>Edit</strong> to add or update the title of the <em>Case Collection</em>. Enter up to 500 characters.</td>
        </tr>
        <tr>
            <td>Description</td>
            <td>Select <strong>Edit</strong> to enter a description for the <em>Case Collection</em>. Enter up to 1,500 characters.</td>
        </tr>
        <tr>
            <td>Case Collection Type</td>
            <td>The type of <em>Case Collection</em>. This is one (1) of the following:
            <ul>
            <li><em>CIOMS I PII Masked & Study Blinded</em></li>
            <li><em>CIOMS I PII Unmasked & Study Unblinded</em></li>
            <li><em>E2B R3</em></li>
            </ul>
            </td>
        </tr>
        <tr>
            <td>Last Ran</td>
            <td>The date and time that the <em>Generate Document Collection</em> action was last used. </td>
        </tr>
        <tr>
            <td>CIOMS I Masked Document Collection</td>
            <td>Vault populates a link to the associated binder of safety reports, if one (1) exists.<br>This field appears only for the <em>CIOMS I PII Masked & Study Blinded</em> type of <em>Case Collection</em>.</td>
        </tr>
        <tr>
            <td>CIOMS I Unmasked Document Collection</td>
            <td>Vault populates a link to the associated binder of safety reports, if one (1) exists.<br>This field appears only for the <em>CIOMS I PII Unmasked & Study Unblinded</em> type of <em>Case Collection</em>.</td>
        </tr>
        <tr>
            <td>E2B R3 Document Collection</td>
            <td>Vault populates a link to the associated binder of safety reports, if one (1) exists.<br>This field appears only for the <em>E2B R3</em> type of <em>Case Collection</em>.</td>
        </tr>
        <tr>
            <td><a id="case-version-setting"></a>Case Version Setting</td>
            <td>Select whether you want the <a href="#generate-collection"><em>Generate Document Collection</em></a> action to generate safety reports for the <strong>Latest Case Version</strong> or for each <strong>Specific Case Version</strong>. If left blank, Vault exports reports for the latest <em>Case</em> version.</td>
        </tr>
    </tbody>
</table>

## Manage Case Numbers in the Collection

Within each _Case Collection_ is a _Case Numbers_ section. By referencing _Case Numbers_, Vault has a complete view of all _Case_ versions and always exports the latest version of the _Case_. Expand the section to view a list of all _Case Numbers_ in the collection. Select any _Case Number_ to view a summary with the following information:

* Details
* Case Versions
* Inbox Items
* Open Case Tasks
* Complete Case Tasks
* User Tasks
* Workflow Timeline
* System fields

Use the procedures below to add or remove _Case Numbers_.

### Add Case Numbers to a Collection

To add _Case Numbers_ to a _Case Collection_:

1. Expand the **Case Numbers** section.
2. Select **Add**.
3. Use the search bar and filters to find _Case Numbers_.
4. Select the checkbox next to each _Case Number_ you want to add or select **Select All** to quickly select all _Case Numbers_ in the list.
5. Select **OK**.

**Result**

The _Case Numbers_ section includes the selected _Cases_.

### Remove Case Numbers from a Collection

To remove a single _Case Number_ from a _Case Collection_, in the _Case Numbers_ section, select the **Actions** menu on the _Case Number_ and then select **Remove**. Vault prompts you to confirm the removal.

To remove multiple _Case Numbers_ from a _Case Collection_:

1. Expand the **Case Numbers** section
2. Select **Add**.
3. Clear the checkboxes next to each _Case Number_ you want to remove.
4. Select **OK**.

**Result**

The _Case Numbers_ section excludes the removed _Case Numbers_.

## Generate a Safety Report Collection {#generate-collection}

You can generate safety reports for all _Case Numbers_ in a _Case Collection_ with a single action. Each collection can include up to 1,000 _Cases_. Depending on your selection in the <a href="#case-version-setting"><em>Case Version Setting</em></a> field, Vault generates safety reports for the latest or for each <em>Case</em> version. From within the _Case Collection_, select the **All Actions** menu and then select **Generate Document Collection**. 

When the safety report collection generates, Vault sends an email and notification. Vault populates a link to the binder in the applicable field based on the collection type. The applicable field is one (1) of the following:

* _CIOMS I Masked Document Collection_
* _CIOMS I Unmasked Document Collection_
* _E2B R3 Document Collection_

You may need to refresh the page to see the link.

### Updating a Safety Report Collection

After generating a binder, you can update the included safety report documents. This is useful when you want to add or remove _Case Numbers_ or update document versions. From within the _Case Collection_, select the **All Actions** menu and then select **Generate Document Collection**. Vault updates the existing binder.

When you remove _Case Numbers_ from the collection, related forms are removed from the regenerated binder.

#### Document Generation and Upversioning {#doc-gen}

When you generate safety reports through the _Generate Document Collection_ action, Vault generates new or upversions existing documents for _Case Numbers_ except when both of the following criteria are met:

* The _Case_ is in the _Closed_ state.
* A document is already linked to the _Case Number_.

If you have configured the _Auto-Generate Case Forms with Case Closure_ job for CIOMS I forms, most _Cases_ will meet these criteria and Vault will not generate or upversion documents.