The following is a list of new features introduced in 20R3 and details on how to make each feature available.
For each feature, the list includes information on how enablement works and links for enablement instructions for each feature. For general template changes, see the 20R3 Template Revisions page, which will be available on November 26th. You can see detailed explanations for the features below in What’s New in 20R3.
Safety
| Feature | Enablement | Additional Information |
|---|---|---|
| CIOMS Enhancements | Auto-on | - |
| Generate ICH E2B R2 | Auto-on | - |
| ICH E2B R3 Submission Validation | Auto-on | - |
| VAERS Combination Products Submission | Configuration | Admins must perform the following configuration to enable vaccine combination products: |
| Email Distributions & Submissions | Configuration | Enable Email Submissions and Distributions |
| MHRA Submission Setup (BREXIT) | Configuration | Admins must perform configuration to move the United Kingdom out of the jurisdiction of the EMA and add it to the jurisdiction of the MHRA in addition to setting up the MHRA Gateway. |
| EMA/UK Vaccines Submission | Configuration | Enable Vaccines and VAERS Submissions |
| Auto-Submissions | Configuration | Enable Auto-Submissions |
| ICH E2B R3 Case Validation | Configuration | Enable E2B Case Validation and Submissions |
| VAERS Submission | Configuration | Enable Vaccines and VAERS Submissions |
| Masked Distribution for VAERS E2B R3 File Format | Auto-on* | Controlled using the Mask PII, Mask E2B, and Mask Unblinded Content fields.
*Legacy Vaults may need to perform additional configuration to Enable Masked Distributions. |
| System Managed Lock Object Protection (Approved, Closed, Superseded, Locked) | Auto-on | - |
| Atomic Security Support on App Controls | Auto-on | - |
| PBRER Unmasked Cumulative SAE from Clinical Trials and Line Listings | Auto-on | *The unmasked Cumulative SAE from Clinical Trials table is automatically generated for PBRER without any configuration. However, blind protection will be applied so that only authorized users may access unmasked versions. The "Document(s) to Generate" picklist and the "Generate Masked Document" checkbox must be configured to appear on the object layout. |
| Local Region Submissions and Language Translation Support | Configuration | Enable Localized Submissions and Translation Support |
| Automatic Email of Case Questionnaire & Scheduled Reminders | Configuration | Enable Automatic Email of Case Questionnaire & Scheduled Reminders |
| Add Regulatory Agencies as Standard Organizations | Admin Checkbox | Enable Regulatory Agencies |
| Multilingual MedDRA | Admin Checkbox | Enable Multilingual MedDRA |
| Extended Data Model for Vaccines | Configuration | Enable Vaccines and VAERS Submissions |
| Extended Data Model for Vaccines | Configuration | - |
Performance and Infrastructure Enhancements:
|
Auto-on | - |
Safety.AI
Note: While most of the Safety.AI features are auto-on, you must perform one-time configuration on your Vault to display Safety.AI components and make Safety.AI features available. The steps to configure Safety.AI are different depending on the Vault Safety release that your Vault was initially deployed from.
| Feature | Enablement | Additional Information |
|---|---|---|
| Inbox Item Security and Audit Trail | Auto-on | - |
| Inbox Item Date Validations | Auto-on | - |
| Manual AER Intake | Auto-on | - |
| Inbox Item Document Linking | Auto-on | - |
| Case Level Seriousness Detection For Inbox Priority | Auto-on | - |
| Vaccine Administration Facility and Cause of Death Intake | Auto-on | - |
| Structured Case Data Intake and New Inbox Item Fields | Auto-on | - |
| Human Verification Enhancements For Predictions | Auto-on | - |
| Case Contact Intake and Classification | Auto-on | - |
| Intake and Verification for New Product and Reporter Fields | Auto-on | - |
| Product And Medical Event Classification | Auto-on | - |
| Promote to Case from Inbox Item | Configuration | Admins must perform configuration to add the Promote to Case user action to the Inbox Item object. |
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. |
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