20R1 Safety Feature Enablement

The following is a list of new features introduced in 20R1.

For each feature, the list includes information on how enablement works and which applications include the feature. You can see detailed explanations for the features below in What’s New in 20R1.

Case Intake

Feature Enablement Additional Information
Study Arms and Blinded Product Names Configuration Enable Study Arms and Blinded Product Names
Study Site Reporters Configuration Enable Study Site Reporter
E2B Import: Product Matching Enhancements Auto-on -

Case Processing

Feature Enablement Additional Information
Medical Review Enhancements Auto-on -
Symptom Classification for Adverse Events Auto-on Depending on your Vault settings, these fields will appear automatically or may need to be added to page layouts before they appear. Contact your Veeva Services representative for more information.
Case Level Relatedness and Automatic SUSAR/SAE Detection Auto-on The Relatedness filter is available automatically on the Case tab for all users with no additional action required. However, Admins must update page layouts to add the Reporter Assessment Result and Relatedness fields, as well as some other configuration changes.
Enable Case Level Relatedness and Automatic SUSAR/SAE Tagging provides instructions.
Blinded Case Previews Auto-on -
Controlled Vocabulary: Extended Configurability Auto-on While this feature is auto-on, to enable status changes to deactivate Controlled Vocabulary records, an administrator must Enable Controlled Vocabulary User Actions
Case Product Dose and Indication Sections Configuration Enable Case Product Dose and Indication Sections
Frequency: Multi-Option Control Auto-on -
Uniform Control Enhancements Auto-on -
Precise Naming for Assessment Matrix, Case Product, and Adverse Event Auto-on -
Case Product Drug Role: Treatment Support Contact Veeva Services to request configuration upgrades to enable this feature in your Vault

Coding

Feature Enablement Additional Information
MedDRA Auto-Coding Configuration Enable MedDRA Auto-Coding
xEVMPD Dosage Forms Configuration Enable xEVMPD Dosage Forms and Non-Standard Dose Units
Non-Standard Dose Units While this feature is Auto-on, an administrator must grant the Case Entry Actions permission set access to edit new fields. Enable xEVMPD Dosage Forms and Non-Standard Dose Units provides instructions. -

Monitoring

Feature Enablement Additional Information
AESI and Configurable Watchlists Configuration Enable Adverse Event Watchlists
Standardized MedDRA Queries and Custom Queries Configuration Enable Standardized and Custom MedDRA Queries

Submissions and Distributions

Feature Enablement Additional Information
Masked Content Distributions Configuration Enable Masked Distributions
CIOMS I Form Update and Comprehensive Overflows Auto-on While this feature is Auto-on, to leverage the new CIOMS Remarks field, an administrator must add it to the Case Detail Page Layout and grant the following permission sets access to edit this field on the Product object:
  • Case Entry Actions
  • Case Intake Actions
  • Case Review Actions
FDA 3500A Comprehensive Overflows Auto-on While this feature is Auto-on, to leverage the new National Drug Code field, an administrator must add it to the Product Registration Detail Page Layout and grant the following permission sets access to edit this field on the Product Registration object:
  • Case Entry Actions
  • Case Intake Actions
  • Case Review Actions
E2B Notification Links Auto-on -

Integrations

Feature Enablement Additional Information
Import Narrative API Auto-on -

Enablement Details

See the following explanations for enablement options:

Enablement Description
Auto-On Automatically activated and no configuration is required before using the feature; note that in some cases, a new feature is dependent on another feature that must be enabled or configured.
Admin Checkbox Admins must turn on the feature with an Admin checkbox. Note that some “Auto-On” features have a checkbox setting that hides the feature; these will show “Auto-On.”
Configuration Admins must configure the feature (separately from an Admin checkbox) before it is available to use or is active; for example, an Admin must add document templates before users can create documents from templates.
Support On/off option controlled by Support.