The following is a list of new features introduced in 20R2.
For each feature, the list includes information on how enablement works and links for enablement instructions for each feature. For general template changes, see 20R2 Template Revisions page. You can see detailed explanations for the features below in What’s New in 20R2.
Safety
| Feature | Enablement | Additional Information |
|---|---|---|
| Health Canada E2B R2 Export | Auto-on | - |
| Optimized Submissions: Local Datasheets & Primary Expectedness | Auto-on | Auto-On in Vaults with Manage Product Datasheets configured |
| E2B R2 & R3 Validation | Auto-on | - |
| E2B R2 Product Import Converter and Other E2B Enhancements | Auto-on | - |
| PSUR Cumulative Tabulations and CIOMSII Line Listings | Configuration | Enable PSUR Cumulative Tabulations and CIOMS II Line Listings |
| Combination Products | Configuration | Enable Combination Products |
| DSUR Appendices (Cumulative SAR, Death Cases), DSUR Masked Distribution | Configuration | Enable DSUR Appendices and Masked DSUR Reports |
| XLSX Report Templates | Configuration | Enable XLSX Aggregate Report Templates |
| Case Locked Icon in Approved, Closed, and Superseded State | Auto-on | - |
| Copy Report Type and Receipt Date from AER Source Document Vault Metadata | Auto-on | - |
| Duplicate Detection Enhancements | Auto-on | - |
| MedDRA Auto-Coding Control | Auto-on | - |
| Manual Case Lock | Configuration | Enable Manual Case Locking: User Check In and Check Out |
| Case Product Drug Role: Treatment | Configuration | To enable this feature, an Admin must make the Treatment Controlled Vocabulary record Active. You may need to first Configure Controlled Vocabulary User Actions to be able to change the status to Active. |
| Medical Review Timeline | Configuration | Enable the Medical Review Timeline |
| Deprecated Controlled Vocabularies | Configuration | Enable Deprecated Controlled Vocabulary User Actions |
| Substances | Configuration | Enable Substances |
| MedDRA: Centralization | Configuration | Admins can update their MedDRA Dictionary settings to turn on centralized MedDRA |
| MedDRA Browser Hierarchy Tree View | Auto-on | - |
| Performance Optimization: Promote to Case | Auto-on | - |
| WHODrug Version Selection from Central Database | Configuration | Admins can update their WHODrug Dictionary settings to select a WHODrug version from the central database |
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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