Learn how to group Case Numbers together 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 Safety 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 in a single action. The system exports all forms to a binder and updates are version-controlled. This makes downloading and sharing Document Collections quick and easy.
The same Cases can be added to multiple Case Collections if needed for different reports or in different formats.
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, complete the following steps:
- On the Cases tab, use filters to list the Cases you want to include in the collection. See Searching Vault: Smart Filtering for more information.
- In the All Actions menu, under Perform Bulk Action, select All [n] records.
- On the Refine Selection page, you can 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, the system sends an email notification and generates a system 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. In the email, select the success or failure link to download a CSV file with Case Number details.
View Case Collections
Find all Case Collections under the Case Collections tab. Select a Case Collection to view the Case Collection type, generate or access the associated binder, and manage Case Numbers in the Collection.
Case Collection Details Fields
| Field | Description |
|---|---|
| Collection Name | A system-generated 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:
|
| CIOMS I Masked Document Collection | A system-generated link to the associated binder of safety reports, if one (1) has been generated. This field appears only for the CIOMS I PII Masked & Study Blinded Case Collection type. |
| CIOMS I Unmasked Document Collection | A system-generated link to the associated binder of safety reports, if one (1) has been generated. This field appears only for the CIOMS I PII Unmasked & Study Unblinded Case Collection type. |
| E2B R3 Document Collection | A system-generated link to the associated binder of safety reports, if one (1) has been generated. This field appears only for the E2B R3 Case Collection type. |
| Last Ran | The date and time that the Generate Document Collection action was last used. |
Manage Case Numbers in the Collection
Within each Case Collection is a Case Numbers section. By referencing Case Numbers, the system 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 and complete the following steps:
- 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. The system prompts you to confirm the removal.
To remove multiple Case Numbers from a Case Collection, expand the Case Numbers section and complete the following steps:
- 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.
From within the Case Collection, select the All Actions menu and then select Generate Document Collection.
A link to the binder is populated in the applicable field. Depending on the collection type, this may be any of the following fields:
- 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.
Select the binder link to view and work with the documents. For more information, see Binders Overview.
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. The system updates the existing binder.
When you remove Case Numbers from the Collection, related forms are removed from the regenerated binder.
Working with Safety Report Binders
You can view a binder by selecting the link on the associated Case Collection. You can also find binders generated from Case Collections in the Vault Library. For more information, see Searching Vault.
Vault Safety includes the following safety report binder document types, subtypes, and classifications:
- Case Binder > Case Collection Binder > CIOMS Masked Case Collection
- Case Binder > Case Collection Binder > CIOMS Unmasked Case Collection
- Case Binder > Case Collection Binder > E2B Case Collection
Safety Report Versions
When generating safety reports for a Case Collection, the system creates or updates document versions based on the latest Case version’s state and whether safety reports already exist in that format. The system generates a report for the latest Case version if one (1) does not already exist. The report is added to the binder and the Case.
CIOMS I Masked Form Generation Considerations
The system completes the following configuration when generating CIOMS I Masked forms:
- The Redacted field is set to Yes.
- If the Study Case version’s Blind Protection field is set to On, the expected study content is blinded.
E2B(R3) Generation Report Considerations
Consider the following when generating E2B(R3) reports:
- The format for E2B(R3) reports is always ICH E2B(R3). Localized E2B(R3) reports cannot be generated from Case Collections.
- When generating ICH E2B(R3) reports for Case Collections, the system populates some required data elements as outlined in the following table:
| E2B Data Element Name | Populated Value |
|---|---|
| N.1.2 Batch Number | The system generates a batch number. |
| N.1.3 Batch Sender Identifier | The system populates "SENDERID". |
| N.1.4 Batch Receiver Identifier | The system populates "RECEIVERID". |
| N.2.r.2 Message Sender Identifier | The system populates "SENDERID". |
| N.2.r.3 Message Receiver Identifier | The system populates "RECEIVERID". |