By default, the Create Related Records wizard allows users to bulk create local regulatory information (Activities, Submissions, Regulatory Objectives) across many markets from a given Event record. For situations where an Event’s scope later increases or decreases, the Update Local Regulatory Information wizard allows users to quickly push the new or updated details in bulk to these existing local records. This capability is useful when, for example:
- A new Packaging and its related details (such as Shelf Life or Condition) are added to an Event with existing Submissions and Regulatory Objectives for many markets.
- A Change Item requires a new Labeling Concept, and that Change Item is already related to a number of Activities.
- Event details are required for content planning in RIM Submissions.
Note: This feature is available in RIM Registrations Vaults configured for the Create Related Records wizard.
Configuration Overview
To configure your Vault to update regulatory information:
- Activate the Last Sent to Impacted Markets field within all of the Event relationship objects inventoried below. Then, add the field to all applicable object page layouts.
- Recommended: Add the Last Sent to Impacted Markets field to the “System Information” or other similar layout section.
- Recommended: Add page layout rules to prevent users from editing Event relationship records when the Last Sent to Impacted Markets field is populated. This
- Activate the Event object’s Local Regulatory Info Last Created field, then add it to all applicable object page layouts. We recommend including this field in the “System Information” or other similar layout section.
- Create a new object action for the Event object using the Update Local Regulatory Information action. During configuration, do not check the Available in All Lifecycle States option. Then, associate the action with all applicable Event object types.
- Within the Event object lifecycle:
- Configure the Update Local Regulatory Information action as a user action on all applicable lifecycle states.
- Recommended: Relabel the existing Review Related Records user action to “Review Local Regulatory Information”. This existing action is located on the lifecycle state mapped to the In Data Review state, and is related to the Create Related Records wizard’s review configuration.
- Recommended: Review your Vault’s field configuration for all Activity, Regulatory Objective, and Submission relationship objects. For any relationship fields configured with a default value, we recommend moving this configuration to the corresponding Event relationship object instead. Otherwise, this wizard limitation results in duplicate records, as Vault cannot properly detect duplicates when comparing the user-selected Event details with existing Activity, Submission, and Regulatory Objective relationship records.
- Optional: Enable Change Item grouping. This assists RIM users in assessing and dispositioning single changes that involve many products and/or packaging types by grouping records by Product Family within the Update Local Regulatory Information wizard. To enable this feature:
- Activate the Change Item object type within the Change Item, Event Change Item, Activity Change Item objects and ensure users are assigned Read, Create, and Edit permissions for these objects via assigned permission sets.
- Navigate to Admin > Settings > Application Settings and select the Enable Grouping of Change Items by Product Family Application Setting.
- Activate the Enable Updating of Local Regulatory Information Application Setting, then use the optional Lifecycle States sub-settings to prevent Vault from updating Activity, Submission, and/or Regulatory Objective records in the selected states.
Event & Relationship Object Inventory
This feature requires configuration within the Event object, its object types, as well as the listed Event relationship objects and their related types.
| Object | Object Types |
|---|---|
| Event | Investigational Event Labeling Event Manufacturing Event Other Event Regulatory Event Safety Event |
| Event Active Substance | N/A |
| Event Authorization | Device Certificate Device Listing Device Premarket Submission |
| Event Change Item | Event Change Item Event Packaging Change Event Product Change |
| Event Change Item Labeling Concept | N/A |
| Event Clinical Study | N/A |
| Event Extended eCTD Keyword | eCTD Component eCTD Container eCTD Descriptor eCTD Facility |
| Event Inactive Ingredient | N/A |
| Event Indication | Event Full Indication Text Event Indication |
Event Nomenclature Code (event_product_classification__v) |
N/A |
| Event Nonclinical Study | N/A |
Event Organization (event_site_organization__v) |
Product Organization Site Organization |
| Event Packaging | Event Device Packaging Event Drug Packaging |
| Event Packaging Characteristic | UDI Attributes UDI Clinical Size |
| Event Pharmaceutical Form | N/A |
Event Product (event_drug_product__rim) |
Event Device Product Event Drug Product |
| Event Product Characteristic | Basic UDI Attributes Manufactured Dosage Form Physical Characteristics |
| Event Regulatory Text | Device Description Device Indications for Use Device Intended Use Device Trade Name Drug Trade Name |
Event Shelf Life or Condition (event_shelf_life_and_storage__v) |
Bulk Ingredient Bulk Product Bulk Substance Device Critical Warning Device Shelf Life Device Storage and Handling Condition Medicinal Product Container Level Medicinal Product Packaging Level |
| Event Site Contact | N/A |
| Event Site Role | N/A |
Related Permissions
Users updating local regulatory information should have all relevant permissions for the Create Related Records wizard. Additionally, they must be assigned a permission set with the below Update Local Regulatory Information wizard-specific permissions.
| Permission Label | Permission |
|---|---|
| Objects: Activity Change Item | Read, Create, Edit |
| Objects: Activity Labeling Concept | Read, Create, Edit |
| Objects: Event: [All listed Event object types] | Read, Create, Edit |
| Objects: Event: Object Field Permissions: Local Regulatory Info Last Created | Read, Edit |
| Objects: Event: Object Action Permissions: Update Local Regulatory Information | View, Execute |
| Objects: [All listed Event relationship objects] | Read, Create, Edit |
| Objects: Labeling Concept | Read |
| Objects: [All relevant Regulatory Objective relationship objects] | Read, Create, Edit |
| Objects: [All relevant Submission relationship objects] | Read, Create, Edit |