Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
The following is a list of new features introduced in 21R1 and details on how to make each feature available. For a full list of Vault Safety features that require configuration, see Feature Enablement.
For general template changes, see the 21R1 Template Revisions page, which will be available on April 15th. You can see detailed explanations for the features below in 21R1 New Features.
Safety
| Feature | Enablement | Additional Information |
|---|---|---|
| E2B R2 ACK for Inbound Transmission | Auto-On |
- |
| EMA E2B R3 Submission Validation | Auto-On * |
This feature is Auto-On. However, if ICH Submission Validation was not previously enabled in the 20R3 release, this feature requires configuration on the Transmission (Submission and Distribution) to add the Validation Results section to the Page Layout. |
| Local Expedited, Downgrade, and Postmarket Study Submissions | Auto-On * |
This feature is available automatically with no additional action required for customers who have enabled the Evaluate Reporting Obligations action, which was introduced in 19R3 as part of the EMA Submissions feature. |
| Multi-Case E2B Import via API/AS2 | Auto-On * |
This feature will be available automatically in a future release for vaults with AS2 Gateway or API Transmissions already configured. In 21R1, contact Veeva Managed Services to request this feature. |
| Multiple Case E2B Import | Auto-On |
- |
| PADER Transmission Date Filter | Auto-On * |
This feature is available automatically with no additional action required for customers who have configured PADER aggregate reports. This feature will not impact previously generated reports. Reports must be re-generated to take effect. |
| Postmarket Studies and Literature enhancements for PADER, PBRER, PSUR, CIOMS and 3500A | Auto-On |
This feature is available automatically for customers who are using PADER, PBRER, PSUR, CIOMS I, or 3500A. However, there is some page layout configuration for the Study Type field. See Enable Postmarket Studies for instructions. This feature will not impact previously generated reports. Reports must be re-generated to take effect. |
| Promote to Case Follow-up: Set Follow-up Receipt Date to Initial Receipt Date | Auto-On * |
This feature is available automatically with no additional action required. This new default behavior takes effect for new cases when they are created from an AER. This feature does not update existing cases. |
| VAERS Certification Enhancements | Auto-On * |
This feature will be available automatically in a future release for vaults with Vaccines and VAERS Submissions enabled. In 21R1, contact Veeva Managed Services to request this feature. To display VAERS related dosage fields for external vaccines, the External Product Type field must be added to the External Case Product Page Layout. |
| VAERS E2B R3 Submission Validation | Auto-On * |
This feature is Auto-On. However, if ICH Submission Validation was not previously enabled in the 20R3 release, this feature requires configuration on the Transmission (Submission and Distribution) to add the Validation Results section to the Page Layout. |
| PADER Subtotal/Grand Total and New Appendices | Configuration * |
While this enhancement is introduced automatically, an Administrator must upload the templates for the new appendices and replace the existing PADER Summary Tabulation of ADRs template before generating PADER reports after the 21R1 release. Also, to generate appendices, the Documents to Generate field must be added to the Aggregate Report Page Layout to allow users to generate the new appendices. See Enable PADER Authoring and Table Generation for instructions. |
| PBRER, PSUR, DSUR Case Approval Date Filter | Auto-On * |
This feature is available automatically in vaults with the Filter Cases By field. If this field is not on the Aggregate Report Page Layout, it must be added to the page layout for users be able to specify the Case Approval Date. Enable Filter Cases by Approval Date in Aggregate Reports provides instructions. Reports must be re-generated for this feature to take effect. |
| Tracking Non-Submittable Cases (Suppress Submission) | Configuration |
See Enable Suppress Submissions for instructions. |
| FDA E2B R2 - Support "FDA Safety Report Type" (A.1.FDA.16) Field | Support * |
This feature won't take effect until the FDA E2B (R2) mandated date requiring the new regional data element A.1.FDA.16 (FDA Safety Report Type). After this date, FDA E2B (R2) files generated from Vault Safety will include this field automatically. |
| Configurable Back Reporting | Support |
- |
| Use Adverse Event PT on CIOMS and MedWatch 3500A | Support * |
Contact Veeva Support to request this feature be enabled. Once enabled, all new CIOMS I and MedWatch 3500A forms will use the MedDRA PT for adverse events. This will not impact previously generated reports, they must be re-rendered to take effect. |
| Duplicate Detection Using External System UID | Auto-On * |
This feature is available automatically with no additional action required. However, an administrator must configure the External System UID field to capture this data on AER and Case page layouts if it was not already added in 20R3. |
| PBRER, PSUR, DSUR, PADER Timezone Awareness and Enhancements | Auto-On * |
This feature is available automatically with no additional action required for customers who have configured the corresponding aggregate report (PBRER, PSUR, DSUR, and PADER). This will not impact previously generated reports. Reports must be re-generated to take effect. |
| PSUR Time to Onset and Group by PT | Auto-On * |
While this feature is auto-on, we recommend that you upload the new 21R1 PSUR report templates, which have updated labels. See Enable PSUR Cumulative Tabulations and CIOMS II Line Listings for instructions. This feature will not impact previously generated reports. Reports must be re-generated to take effect. |
| Recode Badge for MedDRA Terms | Auto-On |
- |
| Show Assessment Results on CIOMS I | Auto-On |
This feature is available automatically with no additional action required. This feature will take effect for any newly generated CIOMS I form. This will not impact previously generated reports. Reports must be re-generated to take effect. |
| Support VAERS Reason Omitted "Other" | Auto-On |
- |
| Japan (PMDA) Local Fields | Configuration |
See Enable Japanese Localization Fields for instructions. |
| Korea (MFDS) Local Fields | Configuration |
See Enable Local Fields for MFDS (Korea) for instructions. |
| Pregnancy and Parent-Child Case Data Collection Enhancements | Configuration |
See Enable Pregnancy and Parent-Child Case Data Collection for instructions. |
| Case Version and Transmission Sequence Numbers | Auto-On * |
This feature is available automatically. However, this will not stamp previously created cases or transmissions. A buffer of 10,000 unused numbers has been provided for previously created cases; however, this is not automatically applied. Contact Veeva Services to apply this buffer to existing Cases and Transmissions. |
Safety.AI
Note 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.See Configure Your Vault for Safety.AI for instructions.
| Feature | Enablement | Additional Information |
|---|---|---|
| Inbox Item PHI/PII Encryption | Auto-On |
- |
| Dosage Extraction | Auto-On |
- |
| Inbox Item Manual Study Intake | Auto-On * |
While this feature is available automatically, you must update page layouts for study-related fields. See Enable Inbox Item Manual Study Intake for instructions. |
| Inbox Item Manual Data Entry Enhancements | Auto-On * |
While this feature is available automatically, you must update page layouts for study-related fields. |
Enablement Legend
| 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, a Clinical Programmer must create an Item Definition of a certain new Item Type. |
| Support | On/off option controlled by Support. |
