Release Date: October 16, 2020
We are pleased to bring you the following new functionality in this week’s release. See details about feature enablement below.
Reporting
Join Report Views Using Number Fields
This feature allows Admins to join Report Views together in a Multi-Pass report type using number fields. Admins may join using number fields when the number is and is not an aggregate, meaning the number is a calculation created by adding a group to a Report View and applying an aggregate function such as max().
Decrease Maximum Size for Flash Report Emails
This feature reduces the default maximum email size to 3 MB for flash reports in order to avoid potential email distribution issues.
Usability & UI Updates
Filter by All Dates in Object Record Audit Trail
This feature adds the all option back to the Timestamp filter in individual object record audit trails. Users may now more easily view and export complete audit trails for records.
Truncated Search Result Warning
For performance reasons, Vault limits the number of full-text search results to only the first 5,000 most relevant matches. With this release, users who perform full-text searches that hit this limit will now see a banner on the top of the page informing them that some results have been omitted. To see a complete set of results, users must simply apply additional filters before performing another full-text search.
Working with Documents
Re-enable Large Size Asset Inbox Folder Triggers
In the 20R2.2 release, we disabled the automatic processing of files uploaded directly to the Inbox folder on the file staging server and introduced the ability to upload Large Size Asset renditions using the Vault REST API’s Add Multiple Document Renditions endpoint. With this release, we are re-enabling the automatic processing of files placed in the staging server’s Inbox folder. Note that we strongly recommend using the new process of uploading to the file staging server and then using the Add Multiple Document Renditions endpoint to import large files into Vault. This process is more effective and does not require users to rename files after importing them.
Administration
Default by Object Type
This feature allows Admins to configure Field Default values at the object type level that can override Field Default values defined at the base object level. Admins can define default overrides for all field types where default values are allowed.
Domain User UI Enhancement
With this release, the Vault Memberships section on the Domain User record detail page lists only Vaults for which a domain user has an active or inactive Vault membership.
Pages Admin Permission
When a Vault application provides a configurable Page, Admins can use the Pages permission to grant View and Edit permission to control which user can configure the Page. This permission is available in the Configuration section on the Admin tab of the Permission Sets page.
Page Permission
When a Vault application provides a Page to display certain application features, Admins can grant access to view the page via the View permission. This permission is available on the Pages tab of the Permission Sets page.
Platform Data Model Changes
With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Platform data model:
Added the following values to the Language (language__v) picklist:
- Chechen
- Chuvash
- Corsican
- Herero
- Kalaallisut-Greenlandic
- Kirghiz-Kyrgyz
- Mandarin
- Romansh
- Samoan
- Turkmen
Updated the Link (link__sys) field on Checklist related objects to enforce uniqueness and help with migration:
- Checklist Design (checklist_design__sys)
- Section Design (section_design__sys)
- Question Design (question_design__sys)
- Available Answer Design (available_answer_design__sys)
- Dependency Design (dependency_design__sys)
- Checklist Design Master (checklist_design_master__sys)
- Sub-Checklist Design (subchecklist_design__sys)
Clinical Operations
Remove Milestone Inactivation from Archive TMF Job
To improve performance, the Archive TMF job no longer inactivates Milestone records.
Commercial
eCTD Compliance Package Generation
With this release, Admins can configure the following new functionality for eCTD Compliance Package Generation:
- The Regenerate Compliance Package user action allows users to regenerate the Compliance Package.
- The Set binder content state type entry action updates all documents in a binder to match the binder state. For example, when the binder moves from the In Review to Submission Ready state, documents in the binder also move to Submission Ready.
- The Binder Content entry criteria verifies that all documents are in a specified state before the binder moves to the next state.
- The Submission Ready workflow VPK allows users to send the generated Compliance Package binder through its lifecycle until it reaches Steady state.
This feature also allows Vault to automatically add video and audio files to the Compliance Package if the video/audio file is attached to the Promotional Piece as a Final Video/Audio rendition type. Two (2) Submission Ready copies of the clean material are now generated automatically – one (1) copy of the document and one (1) video or audio file. Learn more about eCTD Compliance Packages.
Persist Relationships from Approved and Auto Links on Make a Copy
When enabled, all Linked Document relationships from Approved Links and Auto Links are persisted on new documents created by the Make a Copy action. Note that the corresponding Approved Link and Auto Link annotations are not persisted; only the relationships are copied.
When not enabled, only manual link annotations and Claim Links are persisted by Make a Copy, along with the corresponding Linked Document relationships.
Regardless of the enablement status, Suggested Links in Pending status are never persisted by Make a Copy.
Quality
VPS: eMDR XML Payload Transmission to FDA
With this release, the new Vault Product Surveillance application now supports connection to the FDA gateway for electronically transmitting a generated eMDR XML file from Vault to the FDA’s CDRH agency. This connection will also process response and acknowledgments coming from the FDA back to the Vault for visibility on the transmission’s status.
Learner Homepage
This Vault Training release introduces the Learner Homepage, an intuitive, easy to use dashboard that provides the Learner with an overview of the Learner’s open assignments. Assignment cards display key information such as the related Curriculum, estimated completion time, the training document’s Effective Date, due date, categories, and more. In addition, the Learner can access their completed Training Assignments. These sets of information and the quick-access nature of the interface help Learners make the most of their training time.
Users access the Learner homepage via the My Learning tab, which can be associated with a permission set. Learn more about the Learner homepage.
Mobile Training Task Completion
With this release, Vault Training allows Learners to view and complete Vault Document Training Assignments from mobile device browsers.
When a Learner accesses a Vault Document Training Assignment from a phone or a tablet browser, Vault displays the assignment in a mobile-friendly way that’s appropriate based on the device size. In the mobile interface, the Learner can view the document or documents, scroll through the document pages, view key document metadata, and complete the workflow task with e-signature from their mobile device. Learn more about completing assignments in Vault Training.
Quality Data Model Changes
With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Quality data model to support new features:
The following page components were added to support the new Mobile Training Task Completion feature:
- Vault Training Mobile: Document Information Page (training_mobile_document_info_page__v)
- Vault Training Mobile: Interstitial (training_mobile_interstitial_page__v)
- Vault Training Mobile: Learner Task Page (training_mobile_learner_task_page__v)
- Vault Training Mobile: Success Page (training_mobile_success_page__v)
The following changes were made to support the new Learner Homepage feature:
- Updated the Training Assignment (training_assignment__v) object with the following fields:
- Completion Date (completion_date__v)
- Description (description__v)
- Learner Homepage Card Image (learner_homepage_card_image__v)
- Updated the Assignment Details (assignment_details__v) object with the following fields:
- Completion Date (completion_date__v)
- Updated the Training Requirement (training_requirement__v) object with the following fields:
- Learner Homepage Card Image (learner_homepage_card_image__v)
- Added the tab My Learning (training_my_learning_tab__v)
- Added the page component Vault Training Learner Homepage: My Learning Page (training_my_learning_page__v)
Regulatory
Linking to Submissions Archive Content
In RIM Publishing Vaults, users can now publish link annotations and permalinks that target content in RIM Submissions Archive Vaults. Users can also create hyperlinks to previous submission content.
Japan eCTD XSD 1.0 Publishing & Validation
With this release, RIM Publishing Vaults support the Japan XSD 1.0 specification. Users can now create content plans and generate submissions that are compliant with Japan 1.0 specifications. Vault validates these submissions based on the corresponding Japan Validation Criteria. Learn more about working with Japanese regulatory submissions.
IDMP Phase 2: Algorithms
This feature updates the aggregation algorithm that will recurse through RIM Registrations data to compile submission data in new IDMP objects. The full IDMP feature set will be delivered across multiple releases. Learn more about generating IDMP data.
Enablement Change: IDMP
Previously, customers would need to contact Veeva Support to enable IDMP functionality. Now, customers who wish to configure the IDMP functionality can do so without contacting Veeva Support to request the feature. This does not automatically enable the feature, but makes the configuration options available to Admins. Learn more about configuring your Vault to generate IDMP data.
Safety
Safety features are targeted for tentative availability on October 22, 2020.
Email Distributions & Submissions Configuration
Vault Safety now supports a new type of Transmission Profile for sending submissions and distributions via email with tracking for delivery, opening, and errors. Email transmissions include an Individual Case Safety Report (ICSR) document and can be sent to one or more recipients. The ICSR format, optional cover letter, and mailing list are managed on the transmission profile.
Learn More:
Multilingual MedDRA Admin Checkbox
Central MedDRA now supports the following MedDRA Languages: Chinese, Czech, Dutch, English, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian, and Spanish. This support is a back-end change to serve as a foundation for future enhancements to the MedDRA Browser, Local Case Translation, and Local Case Intake.
This enhancement applies to the FDA VAERS E2B (R3) file format.
Learn More:
- Manage the MedDRA Dictionary: Set Up MedDRA Centralization
- Manage the MedDRA Dictionary: Supported Languages
Enhancements to Vaccine Submissions Auto-on
As part of this release, the Vaccine feature is automatically enabled on all vaults. Enhancements to this feature include translation of Vaccine specific object types, conditional auto-calculation of Age at Vaccination, addition and mapping of Case Contact to VAERS Best Doctor, preventing the creation of multiple Patient Contacts, and the mapping of VAERS-specific acknowledgments to Vault Transmission lifecycle states.
Learn More:
Add Regulatory Agencies as Standard Organizations Admin Checkbox
Vault Safety is now pre-loaded with several worldwide health authorities as Standard Organizations.
Learn More: Manage Organizations: Standard Organizations
Export SDK Extension for Custom Distribution Formats Configuration
Vault Safety now allows custom developers to extend existing E2B XML formats or create their own new text data transfer formats.
High Volume Case Processing Auto-on
Vault Safety now has performance tuning for a high volume of cases.
Replace Configured Unit of Measurement VQL Constraints with System Constraints Auto-on
In this release, Vault Safety will further improve system performance when users create and save Case-related data. To achieve these gains, VQL criteria will be removed from Unit of Measurement fields such as Age, Height, and Duration.
These constraints will be replaced by system-managed validation that will warn users when an incorrect Unit of Measurement is selected.
Case Level Seriousness Detection For Inbox Priority Auto-on
If seriousness is not provided in structured data for reported adverse events, the AI service will now suggest priority for new Inbox Items based on a prediction of case-level seriousness from unstructured data. Users can verify the suggested priority with the predicted seriousness criteria.
Human Verification Enhancements For Predictions Auto-on
With this release, dropdown fields will be searchable to make selection easier, especially from long lists (e.g. Country). Also, Safety.AI will now automatically populate medium confidence level predictions in addition to high-level ones to reduce manual work during data verification.
SiteVault
Source Upload Enhancements
When enabled, this feature adds a Document Type column to the Source Upload grid, allowing SiteVault users to upload other types of source documents, such as deviation logs, AE logs, and signed ICFs. Additionally, SiteVault now warns users if it detects an existing source document of the chosen type for the same participant.
Research Organization Object
The Research Organization object provides a way to group the research sites in an Enterprise SiteVault. This functionality will be expanded upon in future releases.
SiteVault Data Model Changes
Added the following components to support the Research Organization Object feature:
- Added the Research Organization (org__v) object
- Added the Research Organization (org_lifecycle__v) lifecycle
- Added the Research Organization (org__v) field to the Research Site (research_site__v) object
Enablement Details
| Name | Enablement | Application |
|---|---|---|
| Reporting | ||
| Join Report Views Using Number Fields | Configuration | Platform |
| Decrease Maximum Size for Flash Report Emails | Auto-on | Platform |
| Usability & UI Updates | ||
| Filter by All Dates in Object Record Audit Trail | Auto-on | Platform |
| Truncated Search Result Warning | Auto-on | Platform |
| Working with Documents | ||
| Re-enable Large Size Asset Inbox Folder Triggers | Auto-on | Platform |
| Administration | ||
| Default by Object Type | Configuration | Platform |
| Domain User UI Enhancement | Auto-on | Platform |
| Pages Admin Permission | Auto-on | Platform |
| Page Permission | Auto-on | Platform |
| Platform Data Model Changes | ||
| Platform Data Model Changes | Auto-on | Platform |
| Clinical Operations | ||
| Remove Milestone Inactivation from Archive TMF Job | Auto-on | eTMF |
| Commercial | ||
| eCTD Compliance Package Generation | Admin Checkbox | PromoMats |
| Persist Relationships from Approved and Auto Links on Make a Copy | Support | Platform1 |
| Quality | ||
| VPS: eMDR XML Payload Transmission to FDA | Support | Surveillance |
| Learner Homepage | Configuration | Training |
| Mobile Training Task Completion | Configuration | Training |
| Quality Data Model Changes | Auto-on | QMS, QualityDocs, Station Manager, Surveillance, Training |
| Regulatory | ||
| Linking to Submissions Archive Content | Auto-on | RIM Publishing |
| Japan eCTD XSD 1.0 Publishing & Validation | Configuration | RIM Publishing |
| IDMP Phase 2: Algorithms | Auto-on | RIM Registrations |
| Enablement Change: IDMP | Configuration | RIM Registrations |
| SiteVault | ||
| Source Upload Enhancements | Support | SiteVault Enterprise, SiteVault Free |
| Research Organization Object | Auto-on | SiteVault Enterprise, SiteVault Free |
| SiteVault Data Model Changes | Auto-on | SiteVault Enterprise, SiteVault Free |
- Auto Claims Linking is only available in PromoMats Vaults. This feature is currently unavailable in other Vaults.
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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