Enable Create and Export Case and Safety Report Collections

Learn how to configure your Vault for generating exportable Safety Report Collections.

About the Feature

To support reviewing and reporting on groups of Cases, with 24R1 Vault Safety includes Case Collections and the export of multiple E2B(R3) and CIOMS I forms at once. Upon document generation, forms are organized into binders, facilitating easy downloading and sharing of safety reports with partners or relevant health authorities. Additionally, Vault Safety can be configured to generate CIOMS I forms for all Closed Cases daily.

Complete the procedures on this page to enable this feature in your Vault. Then, see Manage Case and Safety Report Collections and Configure the Auto-Generate Case Forms with Case Closure Job for more information.

Configure Security for Case Collection Binders

Grant access to the Case Collection Binder document type as follows:

1. Go to Admin > Configuration > Document Types.
2. On the Case Binder (case_binder__v) > Case Collection Binder (case_collection_binder__v) document type, select the Actions menu and then select Edit Details.
3. Go to the Security tab and use the Create Binder Permission picklist to add groups who should have access to Case Collection binders.
4. Select Save.

Configure Shared Document Fields

Add the Case Collection field to the CIOMS I and E2B(R3) document classifications with field dependencies as follows:

1. Go to Admin > Configuration > Document Fields.
2. Expand Base Document > Case > Individual Case Safety Reports (ICSR).
3. Select CIOMS I and then select Add > Existing Shared Field to add the Case Collection (case_collection__v) field.
4. Repeat step 3 for the E2B(R3) document classification.
5. Go to Admin > Configuration > Field Dependencies.
6. Select Create and complete the following steps:
   1. On the Select the Dependency Rule Type dialog, configure the following details:
      • Select Controlled by document type
      • Type: Case
      • Subtype: Individual Case Safety Reports (ICSR)
      • Classification: CIOMS I
   2. Select OK.
   3. On the Create Field Dependency page, set the following dependency rule:
      • Field > Case Collection > Is hidden
   4. Select Save.
7. Repeat step 6 for the E2B(R3) document classification.

Configure Generate Case Collections Actions

Use the sections below to add the following actions:

• Generate CIOMS I Masked Collection
• Generate CIOMS I Unmasked Collection
• Generate E2B R3 Collection

Add User Actions to the Case Object

Complete the following steps to add the user action to the Case object:

1. Go to Admin > Configuration > Objects > Case > Actions.
2. For each of the actions listed above, select Create, select the action from the picklist, and then select Continue.
3. On the Create Action page, we recommend selecting the Available in All Lifecycle States checkbox. If this does not align with your organization’s standard procedures, do not select the checkbox and see Configure the User Actions on Select States after completing step 4 of this procedure.
4. Select Save.
5. On the Atomic Action Security Defaults dialog, Execute is selected for all lifecycle states by default. For states you do not want the action to be available on, select Hide or View.
6. Select Save.
7. Go to the Object Types tab, select Actions, and then in the All Actions menu, select Edit Object Type Actions.
8. Based on your business process, for applicable object types, select the checkbox for each of the new actions and then select Save.

Configure the User Actions on Select States

To configure the generate Case Collections user actions on specific lifecycle states only, after creating the actions on the Case object (steps 1–4 above), complete the following steps:

1. Go to Admin > Configuration > Object Lifecycles > Case Lifecycle.
2. In the States section, select a state.
3. In the User Actions section, select Edit.
4. Select Create Rule and then save each action with the configuration that follows your organization’s process.
5. Within each lifecycle state, the Atomic Security: Actions setting for each action defaults to Execute. Adjust the settings as needed according to your organization’s process.

Configure the Case Collection Object

To configure the Case Collection object, update the layout and add the Generate Document Collection action.

To complete these procedures, go to Admin > Configure > Objects > Case Collection.

Update the Case Collection Layout

Complete the following steps to update the Case Collection layout:

1. On the Layouts tab, select case_collection_detail_page_layout__c.
2. In the Details section, ensure the following fields are included:
   • Collection Title
   • Description
   • Case Collection Type
   • CIOMS I Masked Document Collection
   • CIOMS I Unmasked Document Collection
   • E2B R3 Document Collection
   • Last Ran
3. Insert the Case Collection-Case Number > Case Number related object section.
   For information on configuring object layout sections, see How to Add Sections.
4. (Optional) Add, move, and remove other fields as desired.
5. Select Save.

Add the Generate Document Collection Action

Complete the following steps to add the Generate Document Collection action to the Case Collection object:

1. On the Actions tab, select Create and then select Generate Document Collection from the picklist.
2. Select Continue.
3. On the Create Action page, select the Available in All Lifecycle States checkbox and then select Save.
4. On the Atomic Action Security Defaults dialog, Execute is selected for all lifecycle states by default. For states you do not want the action to be available on, select Hide or View.
5. Select Save.
6. Go to the Object Types tab, select Actions, and then in the All Actions menu, select Edit Object Type Actions.
7. In the column for each object type, select the Generate Document Collection checkbox and then select Save.

Add the Case Collection Tab

Complete the following steps to add the Case Collections tab to the navigation bar:

1. Go to Admin > Configuration > Tabs.
2. Select Create and then complete the fields as follows:
   1. In the Label field, enter “Case Collection”.
   2. In the Tab Type field, select Object.
   3. In the Object field, select Case Collections.
   4. Under Creation Options, select Prevent record creation.
   5. Select Save.
3. (Optional) Select Reorder to drag and drop the Case Collections tab so it is a sub-tab of the Business Admin (Quick Access) tab and then Save.

Grant Permissions

Ensure your permissions sets grant the appropriate level of access to objects, fields, and actions according to your organization’s process.

Manage permissions from Admin > Users & Groups > Permission Sets > [Permission Set].

Add Object Permissions

Configure permissions for the Case Collection and Case Collection-Case Number objects as follows:

1. On the Objects tab, select Edit.
2. Under Case Collection, select the Read, Create, and Edit checkboxes for each of the following:
   • CIOMS I PII Unmasked & Study Unblinded
   • CIOMS I PII Masked & Study Blinded
   • E2B R3
3. For Case Collection-Case Number, select the Read, Create, Edit, and Delete checkboxes.
4. Select Save.

Add Generate Document Collection Permissions

Configure object field and action permissions for Generate Document Collection as follows:

1. On the Objects tab, select Case Collection.
2. In the Object Field Permissions section, select Edit and then select the Read and Edit checkboxes for the following fields:
   • CIOMS I Masked Document Collection
   • CIOMS I Unmasked Document Collection
   • E2B R3 Document Collection
3. In the Object Action Permissions section, select Edit and then select the View and Execute checkboxes for the Generate Document Collection action.
4. Select Save.

Add Bulk Action Permissions

To create a Case Collection through Case search, grant users bulk action permissions.

Add Case Actions Permissions

Configure permissions for the following Case actions as described in the steps below:

• Generate CIOMS I Masked Collection
• Generate CIOMS I Unmasked Collection
• Generate E2B R3 Collection

1. On the Objects tab, select Case.
2. In the Object Action Permissions section, select Edit.
3. Select the View or Execute checkbox for each action.
4. Select Save.

Add Case Collections Tab Permissions

Complete the following steps to grant permissions for the Case Collections tab in accordance with your organization’s process:

1. On the Tabs tab, select Edit.
2. In the Tabs section, next to Case Collections, select the View checkbox.
3. Select Save.