Automated Case Promotion

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

The system 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.
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

The Smart MedDRA Coding feature supports 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, Smart MedDRA Coding can populate 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).

The system 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.

The system determines how to promote the Inbox Item.

After confirming auto-promotion is possible, the Inbox Item state changes to “Processing” and the system 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.

The system checks whether there is an In-Flight Case in Vault with a matching Case Identifier. If there is no matching Case Identifier, the system 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, the system determines whether the Inbox Item can be merged into that In-Flight Case. See Merge to In-Flight Case for more detail. If the Inbox Item can be merged, the system indicates this by setting the Inbox Item state to Marked as Follow-Up and linking it to the Case.

Note: A new Case is not created at this point in the process.

If the Inbox Item has a matching MRN with the Case, but the Case Identifiers do not match, the system sets the Inbox Item to Marked as Follow-Up. However, manual promotion will result in a Promotion Failed state. See Automated Case Promotion Error Troubleshooting for more information.

If the Inbox Item can not be merged into a Case, the system can promote it 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.

The system 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

The system can use one of the following merge methods to auto-promote an Inbox Item to a Follow-Up Case:

Manual Merge: A Follow-Up Case is created using only the Initial Case data. Once the Inbox Item is imported, you must manually merge the Inbox Item into this 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:

The system creates a Follow-Up Case from only the Initial Case, meaning the Follow-Up Case is identical to the Initial Case.

The system sets the Inbox Item state to Marked as Follow-Up and links it to the Follow-Up 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 Create Case.
Since the Inbox Item is in the Marked as Follow-Up state and is linked to the Follow-Up Case, the system directs you to the Case Compare page. You can compare the two cases and select any changes you want to make.
Auto-calculation can be disabled by your Admin when promoting an Inbox Item. See Inbox Item Follow-Up: Auto-Calculations for more information.

Selecting Merge to Current merges the Inbox Item information into the Follow-Up Case

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:

The system 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:

The system 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, the system sends you a notification with the results of the promotion and a link to the Inbox Item.

When you import an Inbox Item, the system 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 the system displays validation errors, if any. You can use the system error messages to correct any invalid data. If the Inbox Item was successfully imported, you can now attempt Automated Case Promotion.

There are multiple reasons an Inbox Item can be sent to the Promotion Failed state.
One reason is that the Inbox Item and Case have mismatching Case Identifiers, even if they have a matching MRN. In the scenario where an Inbox Item and Case have mismatching Case Identifiers but a matching MRN, the system sets the Inbox Item state to Marked as Follow-Up and upon initiating the Create Case action on the Inbox Item, the system moves the Inbox Item to the Promotion Failed state.

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 of the solutions below:

Check that the Inbox Item is valid and there is no missing information using the Inbox Item Promotion Prerequisites.
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
1. Go to Admin > Configuration > Object Lifecycles > Inbox Item.
2. Select the Missing Information state.
3. Create the following user action:
4. Save the page.
5. 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
1. On the Inbox tab, navigate to the respective Inbox Item.
2. Select Change State to New from the All Actions menu beside it.
3. Manually promote the Inbox Item by selecting Promote to Case from the All Actions menu.