Release Date: March 5, 2021
We are pleased to bring you the following new functionality in this week’s release. See details about feature enablement below.
Working with Documents
PDF/A Document Rendition
In addition to standard PDF viewable document renditions, Vault now supports PDF/A viewable renditions to comply with widely-adopted ISO standards. The PDF/A format is an ISO-standardized (190005) PDF specialized for the archiving of electronic documents. This document format provides a reviewable standard and is common in regulatory submissions. Learn more about PDF/A renditions.
Show Document Number in Cart
Vault now displays the document number for each document in your Cart, which helps to differentiate between documents with similar names. If you start a multi-document workflow from the Cart and there is an issue adding documents to the workflow, the warning dialog presents the document numbers that are causing issues.
This feature was released in 20R3.4 without documentation.
Vault Objects
Web Sections for Object Page Layouts
With this release, Admins and users will see any web sections added to object page layouts through MDL. Web sections are similar to web tabs and can be used to specify the URL of external web content. For example, to display an address’s map location on an Organization record.
Learn more about Web Sections in the Developer Portal.
Show in Tab for Related Document Section
We have renamed the Show in Library link in related document sections of object records to Show in Tab. Clicking on the link opens the list of related documents in a dynamically-generated list of related documents. Previously, the link opened the Library tab. This change resolves an issue where users who did not have access to the Library tab were redirected to the Home tab instead.
This feature was released in 20R3.4 without documentation.
Minor Enhancements
Additional Signature Token
With this release, the Signee Federated ID (signee_federated_id__v) token is available for signatures.
This feature was released in 20R3.4 without documentation.
Access Control
Role Permissions
To simplify complex security profile configurations, Admins can now grant individual permission sets to users outside of security profiles by assigning User Roles.
Role Permissions allow you to differ access between users with the same high-level job, as defined by their Security Profile. Access can differ based on specific application role assignment, which, for example, might be determined by additional responsibilities or training level. Learn more about Managing Permissions with User Roles.
Configuration Migration
Enhance Compare & Configuration Report to Provide Warnings
This feature enhances the Vault Compare and Configuration Reports to provide a list of potential component and configuration issues in a separate error log for easier troubleshooting.
Learn more about Vault Compare and Configuration Reports.
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 to support new features:
The following changes support the Role Permissions feature:
Application Roles (application_role__v) have a new Permission Set (permission_set__sys) field. When a role is assigned to a user, the related permissions are assigned to the user, in addition to security profile permissions.
Role permissions introduce the concept of a role assignment to a user, as opposed to roles applied only in the context of specific documents or object records. A new platform object User Role (user_role__sys) is used to persist user role assignments.
User Role object records can be created, edited, or deleted by a user with the required object permissions and the Admin > Security > Users > Manage User Object permission. This object can be accessed using the standard Vault object Rest API.
Clinical Operations
Site User Deprecation
This feature removes the Site User License Type and associated legacy collaboration features from Vaults not currently utilizing them. This includes the legacy Send Document Package action from the Study Site object and the Multi-Site Document Distribution document lifecycle user action. For customers using this legacy functionality, there will be no change to existing behavior.
Comments for Document Exchange
With this feature, Veeva Site Connect customers can send and receive comments when exchanging documents and document requests with SiteVault. Contact your Managed Services representative to enable this feature.
Veeva Site Connect Notifications Send After Transfer Completion
With this enhancement, Veeva Site Connect users receive notifications related to sending documents and document requests to SiteVault after the transfer is complete. Previously, Vault sent notifications prior to transfer completion.
CDMS & Clinical Operations Vault Connection: SDV Requiredness
This feature allows Admins to configure the CDMS and Clinical Operations Vault Connection to transfer the SDV (Source Data Verification) requiredness status from EDC Vaults to CTMS Vaults. When SDV is required on an Event in EDC, the connection transfers the required status for Subject Visits connected to CTMS Vaults.
CDMS & Clinical Operations Vault Connection: Repeating Visits
This feature supports repeating visits in CTMS Vaults. Additional fields now exist to support scenarios where multiple visits in EDC are mapped to the same Visit Definition.
The CDMS and Clinical Operations Vault Connection now transfers the event label override for Events from EDC Vaults as well as the eligible Event Definitions.
Note: Do not activate this integration until the 21R1 general release is complete for CDMS and Clinical Operations Vaults.
Clinical Operations Data Model Changes
Added the following components to support the Comments for Document Exchange feature. These fields are only active in Vaults with Veeva Site Connect enabled:
- Comments (comments__v)
- Return Comments (return_comments__v)
- Default Comments (default_comments__v)
Added the following components to support the CDMS & Clinical Operations Vault Connection: Repeating Visits feature:
- Monitored Subject Visit (monitored_subject_visit__v)
- Subject Visit (visit__v)
- Payable Item (payable_item__v)
Quality
Self-Registration for Classroom Training
With this feature, Training Administrators can specify whether classroom training requirements allow Learner self-registration. If their classroom training assignment allows self-registration, Learners can then view available classes and register for the one that best fits their schedule.
This allows Vault Training customers to configure a self-service model where Learners can self-register without the involvement of an Administrator or Instructor. Learn more about configuring classroom training.
Flexible Vault Training Job Scheduling
This feature allows Admins to modify the time and frequency of Vault Training’s Update Training Assignments job on the Job Definitions page in the Admin interface. The job is set to daily frequency by default, and can be set to hourly, daily, weekly, or monthly. Learn more about Vault Training Automation.
Update Training Assignment Due Date Without Sending Task Cancellation Email
With this release, when a Training Assignment’s Due Date is updated, a task cancellation email will no longer be sent. The workflow task due date will still be updated. However, if the Training Assignment’s Due Date is before the current date, the workflow task due date will not be updated. The Due Date value can only be the current date or a future date.
US FDA eMDR Enhancements
This release includes significant enhancements to the US FDA eMDR generation and submission feature:
Learn more about Vault Product Surveillance.
EU MIR Data Model Updates
With these data model updates, customers are able to leverage Vault Product Surveillance to triage a complaint that is determined to be a reportable adverse event to a country within the EU utilizing a standard output for an EU Manufacturer Incident Report (EU MIR). This is an extension of Adverse Event Reporting to the US FDA. Learn more about Vault Product Surveillance.
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 and updated the following components to the Quality data model.
Regulatory
IDMP Accelerators: Generate Registered Details & Medicinal Product Details
This feature adds new settings on the Admin > Settings > Application Settings page that allow Vault to automatically create related records when users create new records for certain objects that support IDMP. Automatic record creation helps streamline the data entry process for users while ensuring that data is more accurate. When enabled, Vault can automatically create the following object records:
Learn more about enabling IDMP accelerators and how Vault creates records.
Safety
Safety features are targeted for tentative availability on March 12, 2021.
Multiple Case E2B Import Auto-on
Vault Safety now supports the import of EMA E2B(R3) files that contain multiple cases. When an Inbound Transmission’s Origin field is EMA, the system skips the auto-generation of Submissions with Destination to the EMA during the evaluation of case reporting obligations.
Learn More: Create an AER
Promote to Case Follow-up: Set Follow-up Receipt Date to Initial Receipt Date Auto-on
With this release, when an AER is promoted to a Follow-Up Case, the receipt date on the Follow-Up defaults to the Receipt Date from the initial Case. This change in behavior resolves an issue where the New Information Date (C.1.5 in E2B R3) was possibly earlier than the Receipt Date (C.1.4 in E2B R3) if the Receipt Date was incorrectly entered on the Follow-up AER.
Note: This feature takes effect for new cases when they are created from an AER or imported through E2B file. This does not update existing cases.
Japan (PMDA) Local Fields Configuration
When this feature is enabled, Japanese local data elements required by PMDA (Japan regulatory authority) become available for local data entry.
Learn More:
Postmarket Studies and Literature Enhancements for PADER, PBRER, PSUR, CIOMS and 3500A Configuration
PADER, PBRER, PSUR, CIOMS I, and 3500A have been enhanced to leverage Study Type to account for Postmarket studies. To improve the data entry experience, administrators can now configure Study Type on Studies so that new study cases can automatically default the Study Type.
A new literature flag has been added to Report Type to classify literature. This will be automatically turned on for our standard Literature Report type and can be configured on custom report types to drive literature classification in PADER, PBRER, PSUR, CIOMS I, and 3500A.
Note: This feature is auto-on for customers who are using PADER, PBRER, PSUR, CIOMS I, or 3500A. This will not impact previously generated reports; they must be re-generated to take effect.
Learn More:
- CIOMS I Generation Data Mapping
- FDA 3500A Generation Data Mapping
- Create PBRER Aggregate Reports
- Create PSUR and CIOMS II Line Listing Reports
- Create PADER Aggregate Reports
Tracking Non-Submittable Cases (Suppress Submission) Configuration
When enabled this feature prevents automatic ICSR submission record generation for cases designated as non-submittable (i.e. Invalid, Pregnancy cases, etc). These cases will also be excluded in aggregate reports.
Learn More: Suppress, Nullify, or Amend a Safety Report: Suppress Submissions of a Case Version
Inbox Item Manual Data Entry Enhancements Configuration
Manual Inbox Item intake has been enhanced for better usability. When a user manually creates an Inbox Item, by default the record will now have sections for the Primary Reporter, Suspect Product, and Adverse Event. When a user creates additional Case Contacts, Products, or Medical Events, the new section will be opened at creation. Additionally, when viewing a section with multiple products, events, or contacts, the first item will be expanded by default.
Learn More: Manual Inbox Item Intake
Inbox Item Manual Study Intake Auto-on
Users are now able to select the Study and Study Arm on the Inbox Item to perform manual study case intake. On case promotion, Study and Study Arm information will be downloaded from the Vault Safety Library, including the Study Registration and Study Products, to reduce data entry effort. This enhancement supports open and blinded Studies with Arms.
Learn More: Inbox Item Field Reference
SiteVault
Document Delete With Audit Trail Access
This feature allows SiteVault users with appropriate permissions to delete documents that are in a steady state (such as Current or Final). Users who delete steady-state documents are required to enter a reason for deletion with optional comments. In addition, Admins can more easily access and download audit trails of deleted documents.
Share Profiles Across Sites
With this feature, Profile objects (organizations, products, and patients) can be defined as research organization-wide, which makes them available for use across all sites (such as Sponsor records) or specific to one site (such as local IRBs).
Connected Studies Icon
With this feature, a Connected Study icon is displayed on the header of the Study page layout whenever an active Veeva Site Connect Agreement is in place. This icon indicates users can use SiteVault to exchange documents and data directly to and from the sponsor or CRO’s Vault for the study.
SiteVault: Comments for Document Exchange
With this feature, SiteVault users can send and receive comments when exchanging documents with sponsors or CROs on Connected Studies. Comments are displayed in the Documents to Return, Other Received Documents, and Returned Documents sections of Regulatory Document Requests. Organizations interested in enabling this feature must contact their Managed Services representatives.
End Date Defaulting From File Names
On the bulk source upload page, any dates specified in uploaded file names now default to the End Date field (rather than the Start Date field).
Enablement Details
| Name | Enablement | Application |
|---|---|---|
| Working with Documents | ||
| PDF/A Document Rendition | Configuration | Platform |
| Show Document Number in Cart | Auto-on | Platform |
| Vault Objects | ||
| Web Sections for Object Page Layouts | Configuration | Platform |
| Show in Tab for Related Document Section | Auto-on | Platform |
| Minor Enhancements | ||
| Additional Signature Token | Configuration | Platform |
| Access Control | ||
| Role Permissions | Configuration | Platform |
| Configuration Migration | ||
| Enhance Compare & Configuration Report to Provide Warnings | Auto-on | Platform |
| Platform Data Model Changes | ||
| Platform Data Model Changes | Auto-on | Platform |
| Clinical Operations | ||
| Site User Deprecation | Auto-on | CTMS, Study Startup, eTMF |
| Comments for Document Exchange | Support1 | SiteConnect |
| Veeva Site Connect Notifications Send After Transfer Completion | Auto-on | SiteConnect |
| CDMS & Clinical Operations Vault Connection: SDV Requiredness | Admin Checkbox | CTMS |
| CDMS & Clinical Operations Vault Connection: Repeating Visits | Admin Checkbox | CTMS, Vault Payments |
| Clinical Operations Data Model Changes | Auto-on | CTMS, SiteConnect, Study Startup, Vault Payments, eTMF |
| Quality | ||
| Self-Registration for Classroom Training | Configuration | Training |
| Flexible Vault Training Job Scheduling | Auto-on | Training |
| Update Training Assignment Due Date Without Sending Task Cancellation Email | Auto-on | Training |
| US FDA eMDR Enhancements | Auto-on | Surveillance |
| EU MIR Data Model Updates | Auto-on | Surveillance |
| Quality Data Model Changes | Auto-on | QMS, QualityDocs, Station Manager, Surveillance, Training |
| Regulatory | ||
| IDMP Accelerators: Generate Registered Details & Medicinal Product Details | Admin Checkbox | RIM Registrations |
| SiteVault | ||
| Document Delete With Audit Trail Access | Auto-on | SiteVault Enterprise, SiteVault Free |
| Share Profiles Across Sites | Auto-on | SiteVault Enterprise, SiteVault Free |
| Connected Studies Icon | Auto-on | SiteVault Enterprise, SiteVault Free |
| SiteVault: Comments for Document Exchange | Support1 | SiteConnect, SiteVault Enterprise, SiteVault Free |
| End Date Defaulting From File Names | Auto-on | SiteVault Enterprise, SiteVault Free |
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. |
|---|