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.
Note: This feature is only available on RIM Registrations Vaults and must be configured by an Admin.
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.
Working with Label Concept & Deviation Tracking Records
Labeling Concepts are primarily managed through the Events to which they relate. Similarly, Labeling Deviations are managed through a Labeling Event’s related Activity records. Regulatory Objectives capturing locally-initiated label changes may also have associated Labeling Deviations when the local market’s label differs from what was proposed.
The sections below outline steps for creating and relating these object records manually based upon recommended configuration. Note, however, that your Vault’s configuration may differ, in addition to supporting bulk creation of certain record types.
Creating Labeling Events with Labeling Impact
To create a labeling event with labeling impact:
- Create a new Event record from Admin > Business Admin or a custom object tab such as Registrations > Events.
- In the dialog, select Labeling Event from the drop-down and click Continue.
- Enter a Name and select Yes for Labeling Impact.
- Vault displays additional labeling-specific fields. Populate them and any other fields as required and click Save.
Creating Regulatory Objectives with Labeling Impact
To create a regulatory objective with labeling impact:
- Create a new Regulatory Objective record from Admin > Business Admin or a custom object tab such as Applications > Regulatory Objectives.
- In the dialog, select Regulatory Objective and click Continue.
- Enter a Name, select an Application, and populate any additional fields as required.
- Select Yes for Labeling Impact. Vault displays additional labeling-specific fields. Populate them and any other fields as required and click Save.
Creating Labeling Concepts
To create a labeling concept for an event:
- Create or locate an Event record of the object type Labeling Event.
- Within the Labeling Event, expand the Labeling Concepts panel and click Create.
- Select the Impacted CCDS Section and enter Labeling Concept Text.
- Select a Safety Category and click Save.
Creating Labeling Deviations
To create a labeling deviation for an activity or regulatory objective:
- Create or locate an Event record of the object type Labeling Event.
- Within the Labeling Event’s Activity panel, locate or create an Activity related to the event.
- Navigate to the Activity’s Labeling Deviations panel and click Add. You can select an existing Labeling Deviation or click Create.
- In the resulting dialog, populate the Event, dependent Activity, and additional fields as required. Click Save.
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.
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.
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.
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 & Label Concepts
You can configure the splitting wizard to allow users to select Labeling Concepts to split from an existing Activity.
See Configuring Bundling & Splitting for more information.
See Configuring Label Concept & Deviation Tracking (RIM) to learn about required permissions for working with the object records described here.