Promote to Case

When you promote a record to a Case, the system runs duplicate detection to find potential matches and prevent duplicate Cases.

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About Case Promotion

To create a new Vault Safety Case, you can promote an existing AER or Inbox Item using the Promote to Case action.

When you initiate the Case promotion process, Vault Safety duplicate detection compares the current record against all other Cases in the system. The check is useful in the following scenarios:

  • Preventing duplicate Case creation
  • Creating follow-up Cases
  • Copying patient information to a new Case

Note Once a Case has been created with at least one Case Adverse Event, Case Product, or Case Reporter, you cannot delete the Case record from your vault. Furthermore, you cannot delete the following primary Case child records, which the system automatically creates upon Case promotion:

  • Primary Case Adverse Event
  • Primary Case Reporter
  • Primary Case Product

Another Case promotion method is available for Inbox Items received through an AS2 gateway Transmission. See Automated Case Promotion for more detail.

Prerequisites

The following checklists outline the prerequisites for promoting an Inbox Item or AER to a Case.

Inbox Item Promotion Prerequisites

  • The Organization must be specified on the Inbox Item.
    The Organization is required to ensure only users with permissions in that Organization can view the Inbox Item and the resulting Case.
  • Your vault may be configured to hide the Promote to Case action until the Inbox Item is in the Verified state.
  • Your vault may be configured to hide the Promote to Case action until the following minimum case criteria fields are set:
    • Identifiable Patient
    • Identifiable Reporter
    • One of the following:
      1. Country of the Primary Reporter
      2. Country of the Adverse Event
    • Adverse Event
    • One of the following:
      1. Study
      2. Company Product

AER Promotion Prerequisites

  • The Organization must be specified on the AER.
    The Organization is required to ensure only users with permissions in that Organization can view the AER and the resulting Case.
  • The following minimum case criteria fields must be set to Yes:
    • Identifiable Reported Event
    • Identifiable Patient
    • Identifiable Reporter
    • Identifiable Country
    • Identifiable Company Product

Valid Case Criteria

An AER or Inbox Item should have enough information to qualify as a valid case before you promote to Case.

There are fields on the AER and Inbox Item objects to help you check whether a record has the required information to qualify as a valid case.

The following images show these fields, which are automatically populated based on the data entered on the record:

  • Note For AERs, an Administrator can configure your environment to require additional custom valid case criteria using Vault formulas.

    AER Case Validity Fields
    AER Case Validity Fields
  • Inbox Item Case Validity Fields
    Inbox Item Case Validity Fields

Promote an Inbox Item or AER to a Case

Once you’ve verified that an AER or Inbox Item has all the data required for a valid ICSR, you can access the Promote to Case action from the All Actions (All Actions) menu on the record or by selecting Create Case Action.

Once you initiate the Promote to Case action, duplicate detection runs automatically.

If any information in the record matches an existing Case, the Potential Matches page appears.

If the record does not match any existing Cases, Vault Safety creates the Case and an Inbound Transmission record.

Note Your Administrator can configure your vault to display user actions to promote Inbox Items at any given lifecycle state. For example, a configuration might only allow you to promote the Inbox Item after completing the verification process, or it may allow you to promote when the Inbox Item is still in the Triage state. Refer to your standard operating procedures for more information.

Learn how Case intake and Case promotion consider Inbox Items with Combination Products.

Duplicate Case Detection

During duplicate detection, Vault Safety compares the current record against all other Cases and AERs in the system to find potential matches and prevent duplicates. You’ll see the following screen while the system performs duplicate detection:

Running Duplicate Detection
Running Duplicate Detection

If the system detects matching information, the Potential Matches page appears. Review and complete the Potential Matches page to continue.

Potential Match Page
Potential Matches Page

The left pane lists all potential match Cases with similar or matching information. The Comparison table lists the information for the current record side-by-side with the Case that is a potential match.

The following indicators assist with comparing information:

  • Potential Match represents an exact match.
  • Potential Match represents a partial match or similar information.

Deep Duplicate Detection

You must contact Veeva Support to request deep duplicate search be made available in your vault.

Deep duplicate search compares primary as well as non-primary records. For example, the system compares case information including Patient, primary and non-primary Adverse Events, Study, primary and non-primary Products, and Primary Reporter information.

Deep duplicate search can be used to determine whether each potential match is a likely match or a possible match:

likely-match-tag if all the following are a match:

  • Primary Company/Study Product
  • Patient MRN OR 2 other Patient fields
  • Any 2 Event fields

Note If the UID (UID, WWUID, External UID, or Case Identifiers) match, the system automatically determines the Case is a likely match. A cross compare match (for example, a WWUID matching an External UID) also results in a likely match. This cross-comparison only occurs when deep duplicate detection is enabled.

possible-match-tag if all the following are a match:

  • 2 out of the 3 likely match criteria are met
  • 1 Patient field OR 1 Primary Event field OR 3 Primary Reporter fields

If deep duplicate search is enabled in your vault and the record does not match any existing Cases, a “No Match Found” page appears. You can select one of the following options:

  • Cancel: Cancel the process and return to the Inbox Item. You can then go to the Case tab to perform a manual search for a match.
  • Continue: Create a new Case and an Inbound Transmission.

Complete the Potential Matches Page

  1. In the left pane, select a Case to compare it with the current record.
  2. Review each Case listed in the Comparison table to determine whether the record is a new Case, a new Case with existing patient details, a duplicate of an existing Case, or a follow-up Case.
  3. From the drop-down list beside Possible Duplicate, select one of the following options:
    Option Description
    New Case Select this option if the current record is not a duplicate of any potential matches.
    If you select this option, the system creates the Case and an Inbound Transmission record.
    New Case - Copy Patient Info If the current Inbox Item includes a patient with an existing Case, select the Case, and then select New Case - Copy Patient Info.
    If you select this option, in addition to creating a Case that includes the patient details, you can specify other information to copy, including the following:
    • Medical History
    • Drug History
    • Case Contacts
    • Test Results
    • Suspect/Interacting Products
    • Concomitant Products
    • Narrative
    • Adverse Events to Medical History
    • Concomitant Products to Drug History

    See Copy Patient Information from Existing Case for more detail.

    Note The new Case is not linked to the original Case. However, the audit trail records which information was copied.

    Duplicate If a Case is an exact match to the current record, select the Case, and then select Duplicate.
    If you select this option, the system marks the record as Duplicate and does not create a Case. The system links the duplicate record to the matching Case in the Initial Case field.
    Follow-Up If an AER or Inbox Item is a follow-up to an existing Case, select the Case, and then select Follow-Up.
    If you select this option on an Inbox Item, the system directs you to the Case Compare page. See Inbox Item Follow-Up for more detail.
    If you select this option, the system promotes the AER to a Follow-Up Case. For more information, see Considerations for Follow-Up Promotion on an AER.

    Note This option is not available for Inbox Items that are found to match a Case in the Void, Nullified, Voiding, or Nullifying lifecycle state or a Case in the lifecycle state with the Deleted state type. The Deleted state type can only be mapped to one lifecycle state.

    Mark as Follow-Up Select this option to link the Inbox Item to an In-Flight Case An open Case that has not completed case processing (generally in any state before Approved, Closed, or Superseded).
    and indicate it should be merged with the Case. In order for the action to be successful, the Case must not have completed processing and can not be in a prohibited state.

    If you select this option, the state changes to Marked as Follow-up and a new section, Inbox Item has been marked as a follow-up, appears on the Inbox Item with a link to the associated Case. Note that an administrator must configure the Inbox Item page layout in order for this section to appear. This lets the Case Processor know there is new information on the Inbox Item that should be merged with the In-Flight Case.

    If you do not see this option, an administrator must enable the Mark as Follow-up option in the Case Promotion settings.

    You can undo this action by navigating back to the Inbox Item and selecting Unmark Follow-Up in the All Actions (All Actions) menu.

    Note Promoted Inbox Items cannot be unlinked from the Case.

  4. Select Complete.

How Duplicate Detection Works

The system looks at certain data points on each Case to determine potential matches.

Excluded Case States

Vault Safety compares the current Inbox Item or AER with all Cases and AERs linked to the same Organization, except those in the following states:

Excluded State Description
Superseded Cases The system looks at the latest Case version rather than Superseded versions.
Promoted AERs The system looks at the promoted Case rather than the original AER.
Duplicate AERs The system does not look at Duplicate AERs because they cannot be promoted to Cases.
Rejected AERs The system does not look at Rejected AERs because they cannot be promoted to Cases.

Note Inbox Items are not included in the search for duplicates.

Fields

When searching for duplicate Cases, the system compares information entered or received in the following fields:

Details

If deep duplicate detection is enabled in your vault, the system compares any AER or Inbox Item UID (WWUID, UID, External System UID and Case Identifiers) with any Case UID (WWUID, UID, External System UID and Case Identifiers). You must contact Veeva Support to request this feature.

Primary Product

The system compares values entered in the following fields for the primary Case Product:

  • Product
  • Study
  • Study Product
  • Study Arm

Note When a study Case is blinded, the system cannot compare the Study Product with other Cases.

Note If deep duplicate detection is enabled in your vault, the system can also compare the above field values for up to 10 non-primary Case Products. You must contact Veeva Support to request this feature.

Primary Events

The system compares values entered in the following fields for the primary Case Adverse Event:

  • Event Country
  • Event (Reported)
  • Event (MedDRA)
  • Event Onset

Note If deep duplicate detection is enabled in your vault, the system can also compare the above field values for up to 10 non-primary Case Adverse Events. You must contact Veeva Support to request this feature.

Patient

The system compares values entered in the following Case Patient fields:

  • Patient Initials/ID
  • Gender
  • Date of Birth
  • Age at Onset
  • Gestation
  • Age Group
  • GP MRN
  • Hospital MRN
  • Investigation MRN
  • Specialist MRN

Primary Reporter

The system compares values entered in the following fields for the primary Reporter Case Contact:

  • Reporter First Name
  • Reporter Last Name
  • Reporter Country
  • Reporter Qualification

Note When a study Case is blinded, the system cannot compare the Study Product with other Cases.

Considerations When Promoting an AER to a Follow-Up Case

The following sections describe important information to consider when you promote an AER to a Follow-Up Case, depending on how you created the follow-up AER. This section does not apply to Inbox Items.

For information on creating a Follow-Up Case from an initial Case in the Closed state, see Add a Follow-Up Case.

Promote an E2B Imported AER to a Follow-Up Case

When you promote a Follow-Up Case from an E2B-imported AER, the resulting Follow-Up Case contains only data from the E2B source file.

You must update the Follow-Up Case to add any information from the previous Case version that the E2B source file omits.

Promote a Manually Entered AER to a Follow-Up Case

When you promote a Follow-Up Case from an AER created through manual data entry, the resulting Follow-Up Case contains all data from the initial case and any additional information from the follow-up AER. You may need to correct duplicate information in the resulting Follow-Up Case.

When the Follow-Up AER contains conflicting data from the initial Case, the system reconciles certain information during case promotion.

The following list describes how Vault Safety reconciles certain fields when you promote an AER to a Follow-Up Case:

  • Masked Fields: For fields with a Reason Omitted masking option, the information entered in the AER being promoted to a Follow-Up takes precedence. For example, if the initial Case specified a field value, but the follow-up masked the same field with a Reason Omitted option, the resulting Follow-Up Case blanks the field but maintains the Reason Omitted option.
  • Value and Unit Fields: For the following fields, the latest data in the follow-up overwrites the value from the initial case, including null values:
    • Age
    • Gestation
    • Height
    • Weight
  • Age-Related Fields: The follow-up information takes precedence over the initial case for all age-related fields, including Date of Birth, Age at Onset, and Age Group.
  • Receipt Date: The receipt date remains constant across both the initial and follow-up case versions. The follow-up receipt date is recorded in the New Info Date field.

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