Learn how to group Case Numbers so you can export multiple safety reports at once.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About Case and Safety Report Collections
Vault enables you to organize groups of Case Numbers 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)
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 binder and updates are version-controlled.
The same Cases can be added to multiple Case Collections if needed for different reports or in different formats. Each collection can include up to 1,000 Cases.
Prerequisite
Your Admin must enable Create and Export Case and Safety Report Collections.
Create a Case Collection
To group Case Numbers for exporting to a specified format:
- Navigate to the Cases tab and use filters to list the Cases you want to include in the collection.
- From the All Actions menu, under Perform Bulk Action, select All [n] records.
- On the Refine Selection page, clear checkboxes for any Cases you don’t want to include in the collection, and then select Next.
- On the Choose Action (Step 2) page, under Manage Records, select Record Actions and then select Next.
- 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
- 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
| Field | Description |
|---|---|
| Collection Name | Vault populates a name for the Case Collection. |
| Collection Title | Select Edit to add or update the title of the Case Collection. Enter up to 500 characters. |
| Description | Select Edit to enter a description for the Case Collection. Enter up to 1,500 characters. |
| Case Collection Type | The type of Case Collection. This is one (1) of the following:
|
| Last Ran | The date and time that the Generate Document Collection action was last used. |
| CIOMS I Masked Document Collection | Vault populates a link to the associated binder of safety reports, if one (1) exists. This field appears only for the CIOMS I PII Masked & Study Blinded type of Case Collection. |
| CIOMS I Unmasked Document Collection | Vault populates a link to the associated binder of safety reports, if one (1) exists. This field appears only for the CIOMS I PII Unmasked & Study Unblinded type of Case Collection. |
| E2B R3 Document Collection | Vault populates a link to the associated binder of safety reports, if one (1) exists. This field appears only for the E2B R3 type of Case Collection. |
| Case Version Setting | Select whether you want the Generate Document Collection action to generate safety reports for the Latest Case Version or for each Specific Case Version. If left blank, Vault exports reports for the latest Case version. |
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:
- Expand the Case Numbers section.
- Select Add.
- Use the search bar and filters to find Case Numbers.
- 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.
- 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:
- Expand the Case Numbers section
- Select Add.
- Clear the checkboxes next to each Case Number you want to remove.
- Select OK.
Result
The Case Numbers section excludes the removed Case Numbers.
Generate a Safety Report Collection
You can generate safety reports for all Case Numbers in a Case Collection with a single action. Depending on your selection in the Case Version Setting field, Vault generates safety reports for the latest or for each Case 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
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.