# Configuration for Updating Local Regulatory Information 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.
## Configuration Overview To configure your Vault to update regulatory information: 1. Activate the _Last Sent to Impacted Markets_ field within all of the _Event_ relationship objects [inventoried][1] 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. 2. 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. 3. Within the _Event_ object lifecycle, configure the _Update Local Regulatory Information_ action as a user action on all applicable lifecycle states. 4. 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. 5. 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. 6. Activate the _Enable Updating of Local Regulatory Information_ Application Setting. * Optional: Select and populate one or more of the **Exclude [Activities, Submissions, Regulatory Objectives] in the following states** sub-settings. These settings prevent Vault from pushing new _Event_ details to records where it may not make sense to do so for your organization, such as once an _Activity_ has moved to _In Progress_, or for _Regulatory Objectives_ that have been _Withdrawn_. ### Event & Relationship Object Inventory {#event-and-relationship-object-inventory} This feature requires configuration within the below objects and their related types. | Object | Object Types | |---|---| | Event (`event__rim`) | Investigational Event (`investigational_event__v`)
Labeling Event (`labeling__rim`)
Manufacturing Event (`manufacturing__rim`)
Other Event (`other__rim`)
Regulatory Event (`regulatory_event__rim`)
Safety Event (`safety_event__v`)| | Event Active Substance (`event_active_substance__rim`) | N/A | | Event Authorization (`event_authorization__v`)| Device Certificate (`device_certificate__v`)
Device Listing (`device_listing__v`)
Device Premarket Submission (`device_premarket_submission__v`)| | Event Change Item (`event_change_item__v`) | Event Change Item (`change_item__v`)
Event Packaging Change (`packaging_change__v`)
Event Product Change (`product_change__v`) | | Event Clinical Study (`event_clinical_study__v`) | N/A | | Event Extended eCTD Keyword (`event_extended_ectd_keyword__v`)| eCTD Component (`ectd_component__v`)
eCTD Container (`ectd_container__v`)
eCTD Descriptor (`ectd_descriptor__v`)
eCTD Facility (`ectd_facility__v`) | | Event Inactive Ingredient (`event_inactive_ingredient__rim`) | N/A | | Event Indication (`event_indication__rim`) | Event Full Indication Text (`full_indication_text__v`)
Event Indication (`indication__v`) | | Event Nomenclature Code (`event_product_classification__v`) | N/A | | Event Nonclinical Study (`event_nonclinical_study__v`) | N/A | | Event Organization (`event_site_organization__v`) | Product Organization (`product_organization__v`)
Site Organization (`site_organization__v`) | | Event Packaging (`event_packaging__rim`) | Event Device Packaging (`packaged_device_product__v`)
Event Drug Packaging (`packaged_medicinal_product__v`) | | Event Packaging Characteristic (`event_packaging_characteristic__v`)| UDI Attributes (`udi_attributes__v`)
UDI Clinical Size (`udi_clinical_size__v`) | | Event Pharmaceutical Form (`event_pharmaceutical_form__v`) | N/A | | Event Product (`event_drug_product__rim`) | Event Device Product (`device_product__v`)
Event Drug Product (`drug_product__v`) | | Event Product Characteristic (`event_product_characteristic__v`) | Basic UDI Attributes (`basic_udi_attributes__v`)
Manufactured Dosage Form (`manufactured_dosage_form__v`)
Physical Characteristic (`physical_characteristic__v`) | | Event Regulatory Text (`event_regulatory_text__v`) | Device Description (`device_description__v`)
Device Indications for Use (`device_indications_for_use__v`)
Device Intended Use (`device_intended_use__v`)
Device Trade Name (`device_trade_name__v`)
Drug Trade Name (`drug_trade_name__v`) | | Event Shelf Life or Condition (`event_shelf_life_and_storage__v`) | Bulk Ingredient (`bulk_ingredient__v`)
Bulk Product (`bulk_product__v`)
Bulk Substance (`bulk_substance__v`)
Device Critical Warning (`device_critical_warning__v`)
Device Shelf Life (`device__v`)
Device Storage and Handling Condition (`device_storage_and_handling_condition__v`)
Medicinal Product Container Level (`container__v`)
Medicinal Product Packaging Level (`packaged_product__v`)| | Event Site Contact (`event_site_contact__v`) | N/A | | Event Site Role (`event_site_role__v`) | N/A | | Labeling Concept (`labeling_concept__v`) | N/A | ## Related Permissions {#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][1] _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][1] _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 | [1]: #event-and-relationship-object-inventory [2]: #related-permissions