Label Concept & Deviation Tracking (RIM)

When regulatory events and activities have labeling impact, Label Concept and Deviation Tracking in Vault RIM Registrations allows for detailed tracking and management of the resulting labeling concept updates and deviations. Organizations enter proposed changes and send them to affiliate teams to provide local disposition and capture deviations in local labeling; Vault makes the changes and timelines globally and locally visible while the label content is approved, updated, and submitted.

How Label Concept & Deviation Tracking Works

Labeling Events and Labeling Concepts

When creating an Event record related to drug product labeling (a Labeling Event), you can use the Labeling Impact field to indicate it as such. If Labeling Impact is Yes, Vault presents additional labeling-related fields to capture:

  • CCDS to be Updated and CCDS with Changes Reflected: Impacted versions of the Company Core Data Sheet (CCDS)
  • Safety Category: The risk class to which it belongs
  • Trigger Date: Clock start date for completing the labeling update
  • Due Date: Based on the Trigger Date and risk class

Additionally, when Labeling Impact is Yes, the Labeling Concepts section allows you to create and associate Labeling Concept records corresponding to section level changes proposed for the CCDS.

Activities and Labeling Deviations

Following impact assessment based upon the event’s related Products, you can create Activity records, either manually or in bulk, to provide detail of the new Label Concepts to local affiliates. Referencing the Activity and Label Concept data, local affiliates submit the proposed changes to the local Health Authority. Should the local Health Authority reject or otherwise require updates to the proposed changes, the Labeling Deviations object relationship with Activity allows for tracking and management of instances where the local market’s label differs from what was proposed in the event’s Label Concept.

Regulatory Objective Label Concept Tracking

When label changes are locally-initiated, you can set the Labeling Impact field on the Regulatory Objective record to Yes, displaying additional labeling-related fields to capture Corresponding CCDS and Resulting Local Label, the Safety Category, Trigger Date, and Due Date.

Automatic Record Creation & Automation

When configured by an Admin, Vault can automatically copy Labeling Concept records to underlying Activity records, create Labeling Deviation records based upon the outcome of an Activity lifecycle, and calculate Safety Category and Due Date based upon labeling records.

For Vault to successfully create and auto-name these records, the CCDS Section (ccds_section__v) field is required.

Labeling Concepts

When you manually or bulk create an Activity related to an Event, Vault copies the Event’s Labeling Concept records to the created Activity.

Additionally, as Labeling Concepts are created, edited, or deleted, Vault maintains the related Event and Activity records’ Safety Category based upon the corresponding field within the associated Labeling Concept record as follows:

  • When there are multiple Labeling Concepts with varying safety categories, Vault compares the value across the records and selects the highest-value category (for example, Class I) to set within the Event or Activity.
  • When a Labeling Concept record is deleted, Vault assesses the value across the remaining Activity-related concepts. If no other records exist, Vault clears the Event and Activity records’ Safety Category field.

Labeling Deviations

When an Activity’s associated Labeling Deviation is Accepted for Dependent Countries (as indicated by the Deviation Review Disposition field), Vault:

  • Copies the Labeling Deviation record to any related dependent Activities and sets Deviation Review Disposition to Accepted for Dependent Countries.
  • Creates corresponding Labeling Deviation and Activity-Labeling Deviation records for any related dependent Activities.

When the Labeling Deviation object lifecycle is configured to use the Reviewed state type, Vault also defaults certain fields and creates these records in the mapped lifecycle state.

Additionally, Vault can automatically create Labeling Deviations based on the outcome of the Activity and Activity Labeling Concept lifecycles as follows:

  • When an Activity record reaches the lifecycle state configured as the Filing Rejected lifecycle state type, for example Not Approved.
  • When an Activity Labeling Concept reaches the lifecycle state configured as the Concept Rejected state type, for example Rejected. Vault only creates new records when there are no existing records with the same Activity and Labeling Concept field values.

Labeling Deviations for All Dependent Markets

Depending on your Vault’s configuration, Vault may cascade deviation information to dependent markets. To do this, Vault skips the check which prevents the creation of more than one Labeling Deviation per Activity and Labeling Concept. This can be useful for organizations where a single labeling concept is associated with multiple deviations.

Lead Reference Market Due Date & Activity Due Date

Vault can maintain an Activity record’s Due Date based upon its dependent activities’ Lead Reference Market Due Date:

When an Activity Dependency record is indicated as a lead dependency (its Lead Dependency field is set to Yes), Vault sets the Activity field Lead Reference Market Due Date with the dependency record’s Due Date. Vault allows only one Activity Dependency record to be indicated as the Lead Dependency.

Then, an Admin can optionally configure a custom formula referencing the Lead Reference Market Due Date, in the Activity’s Due Date field to calculate the Activity based upon its dependent activities.

Splitting Activities & Labeling Concepts

During the splitting process, you can select Labeling Concepts to split from an existing Activity.

See Configuring Label Concept & Deviation Tracking (RIM) to learn about required permissions for working with the object records described here.