Inbox Items received through an AS2 gateway, Intake API, E2B import, or Safety-EDC Vault Connection can be automatically promoted to an Initial or Follow-Up Case.
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 Automated Case Promotion
Vault Safety sometimes receives Inbox Items from a source system that require little to no Case triage. Inbox Items received in the following ways can be automatically promoted to a Case:
- Received through an AS2 gateway Transmission
- Received through an Intake API
- Received through the Safety-EDC Vault Connection
- Inbox Items imported from any structured source
Vault then determines whether an automatically promoted Case should be an initial or follow-up version, or should be marked as follow-up.
Prerequisites
Your Admin must perform the following configuration for Automated Case Promotion to proceed:
- Enable Automated Case Promotion on Transmission Profiles. This feature enablement includes enabling Auto Promote and configuring the merge methods on the Transmission Profile being used to receive Cases. To learn more, see Manage Transmission Profiles.
- Enable Automated Case Promotion for E2B Imported Inbox Items.
- To support automatic promotion of Inbox Items generated from email attachments, configure email to Vault Safety Inbox Item
- Configure the Case Promotion Settings Page: Enable Merge to In-Flight Case section.
Note: Automated Case Promotion, Auto-Translation Framework for Local Intake, and Sender-Based Inbound Validations are not compatible. You can enable all three (3) features in your Vault but you can only use one (1) for an inbound Transmission Profile.
Your Admin can also enable Automated Case Promotion for non-Cases. For example, Cases that do not need to be reported to any Health Authorities.
Automated MedDRA Coding
MedDRA coding suggestions are available during Automated Case Promotion. For example, in instances when Automated Case Promotion would be prevented by an incorrect or missing MedDRA code on the source document, Vault populates high-confidence terms, when available, during import or Inbox Item creation. For more information, see Enable Smart MedDRA Coding.
Note: To use auto-coding, your Vault must have an active MedDRA dictionary
Automated Case Promotion Process
The following diagrams illustrate the Automated Case Promotion process:
When Vault generates an Inbox Item, it determines whether Automated Case Promotion is possible:
An Inbox Item is imported using one of the following methods:
A source organization, such as a trading partner or health authority, sends a transmission through an AS2 gateway (E2B file) or Intake API (JSON or E2B file) to be imported as an Inbox Item.
A study site creates an SAE in a CDMS Vault and the Safety-EDC Vault Connection transfers the data to your Safety Vault, generating an Inbox Item.
An Inbox Item is created from an E2B (single E2B, multi-E2B, or ZIP file from your Vault Library or email attachment).
Vault determines if the Inbox Item can be auto-promoted using the following criteria:
Is Auto Promote enabled in the respective transmission profile or for the E2B document fields?
Is the Inbox Item valid for promotion or is it missing information?
If any of these criteria are not met, auto-promotion will not be possible. See Automated Case Promotion Error Troubleshooting to learn about possible solutions for promotion failures.
Vault determines how to promote the Inbox Item.
After confirming auto-promotion is possible, the Inbox Item state changes to “Processing” and Vault determines whether the Inbox Item can be promoted to an Initial Case, merged into an In-Flight Case, or promoted to a Follow-up Case.
Vault checks whether there is an In-Flight Case in Vault with a matching Case Identifier. If there is no matching Case Identifier, Vault promotes the Inbox Item to an Initial Case. For more information on matching Case Identifiers, see Promote to Case.
If there is a Case with a matching Case identifier, Vault determines whether the Inbox Item can be marked as follow-up. The matching Case cannot be in a prohibited state. See Merge to In-Flight Case for more detail.
If the Inbox Item can be merged, Vault indicates this by setting the Inbox Item state to Marked as Follow-Up and linking it to the Case.
If the Inbox Item cannot be merged into a Case, Vault determines if it can be promoted to a Follow-up Case. First, it determines whether to treat the case as serious or non-serious using the following criteria:
- Serious: If the Inbox Item has a Primary Adverse Event AND the Seriousness for the Primary Adverse Event is populated.
The Primary Adverse Event for E2B files is the first entry in the adverse events (section E.I/B.2). - Non-serious: If the Inbox Item does not have a Primary Adverse Event or if the Seriousness field is blank.
Vault determines if the Inbox Item can be created as a Follow-up Case. The matching Case cannot be in a prohibited state. If the matching Case is in a prohibited state, Vault moves the Inbox Item to the Promotion Failed state.
Vault proceeds with the merge method specified on the respective Transmission Profile (if sent from a source organization or CDMS Vault) or on the E2B document (if from E2B import). Your Admin can configure the merge method to use for each Transmission Profile and a user can configure the merge method to use for each uploaded E2B document, depending on whether the Case is serious or non-serious.
Merge Methods
Vault can use one of the following merge methods to auto-promote an Inbox Item to a follow-up Case:
- Manual Merge: Once the Inbox Item is imported, you must manually merge the Inbox Item into a follow-up Case.
- Smart Merge: A follow-up Case is created using both the Inbox Item and initial Case data using default merging behaviour.
- Override: A follow-up Case is created using only the Inbox Item data.
Manual Merge
The following diagram describes the manual merge method:
Vault sets the Inbox Item state to Marked as Follow-Up and links it to the initial Case to indicate they are related.
Once the Inbox Item has been imported into your Vault, you must go to the Inbox Item and select Promote to Follow-up.
Since the Inbox Item is in the Marked as Follow-Up state and is linked to the initial Case, Vault directs you to the Inbox Item to Case Compare page.
Prior to creating a follow-up Case, you can compare the two (2) cases and select any changes you want to make.
For more details on other actions, see Complete the Inbox Item to Case Compare Page.
Auto-calculation can be disabled by your Admin when promoting an Inbox Item. See Inbox Item Follow-Up for more information.
The Inbox Item goes to the Promoted state and links to this follow-up Case.
Smart Merge
The following diagram describes the smart merge method:
Vault creates a follow-up Case from the Inbox Item information and the initial Case using the default merge behaviour.
The Inbox Item goes to the Promoted state and links to this follow-up Case.
Override Merge
The following diagram describes the override merge method:
Vault creates a follow-up Case using only the Inbox Item information, meaning the follow-up Case is identical to the Inbox Item.
If the initial Case has any narrative documents, they will be appended to the generated narratives on the follow-up Case. Document references from the initial Case and Inbox Item will be combined on the follow-up Case.
The Inbox Item goes to the Promoted state and links to this follow-up Case.
Automated Case Promotion Error Troubleshooting
After automated Case promotion, Vault sends you a notification with the results of the promotion and a link to the Inbox Item.
When you import an Inbox Item, Vault also sends a notification to indicate the results of the import. See Verify an Imported Inbox Item for more information about confirming the success of the import and how Vault displays validation errors, if any. You can use Vault error messages to correct any invalid data. If the Inbox Item was successfully imported, you can now attempt automated Case promotion.
Vault also populates the Automation Message field in the System section of the respective Inbox Item with the reason automated Case promotion failed.
The following section describes workarounds for when automated Case promotion fails.
Workarounds
After attempting automated Case promotion, if your Inbox Item enters the Missing Information or Promotion Failed state, use one (1) of the solutions below:
- Check that the Inbox Item is valid and there is no missing information using the Inbox Item promotion prerequisites.
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Use a workaround: Your Admin can create a user action to set the Inbox Item back to the New state so that you can manually promote it.
WORKAROUND PART 1: ADMIN INSTRUCTIONS
Follow the steps below to create the Change State to New user action:
- Navigate to Admin > Configuration > Object Lifecycles > Inbox Item.
- Select the Missing Information state.
- Create the following user action:
- Save the page.
- Repeat step 3 for the Promotion Failed state.
Result
The Change State to New user action is now available for Inbox Items in the Missing Information or Promotion Failed state.WORKAROUND PART 2: USER INSTRUCTIONS
Follow the steps below to manually promote the Inbox Item:
- On the Inbox tab, navigate to the respective Inbox Item.
- Select Change State to New from the All Actions menu beside it.
- From the All Actions menu, select Promote to Case.