New in 20R2.2: Object & Multi-Document Workflow Enhancements, and more

Release Date: August 21, 2020

We are pleased to bring you the following new functionality in this week’s release. See details about feature enablement below.

Lifecycle & Workflow

Object & Multi-Document Workflows: Update Task Due Date

Object Workflows and Multi-Document Workflows now allow users to update a task’s due date with a user action. While due dates can be extended or reduced with this action, the updated date needs to be on or after the day of the update. Due date updates are always per task assignee. Access to the Update Task Due Date action is controlled by permission sets and Atomic Security based on the lifecycle state and the user’s role. Workflow initiators can update the due date at any time. Learn more about using object and multi-document workflows.

Object & Multi-Document Workflows: Ad Hoc Task Instruction

Object Workflows and Multi-Document Workflows now support ad hoc task instructions provided by the workflow initiator in the workflow start dialog. The workflow initiator can provide a different set of instructions to each participant group. Ad hoc task instructions are enabled in the workflow configuration, and can be optional or required.

Ad hoc task instructions are only visible in notifications and emails if the instructions token is configured in the appropriate templates by the workflow administrator. Learn more about configuring object and multi-document workflows.

Object & Multi-Document Workflows: Update Sharing Settings in Task Step

Workflow Admins can now configure object and multi-document workflow task steps to update sharing settings via rules. Admins can configure rules to trigger sharing settings updates upon task completion, cancellation, or assignment. When these rules are executed during the workflow, users are added to a role or removed from a role in object or document sharing settings based on the rule configuration. Learn more about configuring object and multi-document workflows.

Object & Multi-Document Workflows: Additional Task & Workflow Initiator Tokens

Object message templates now support additional tokens for Workflow Initiators and Tasks. This enhancement includes tokens for the workflow initiator’s first name, last name, email, and phone number, as well as tokens for task verdicts.

Workflow Admins can also select task verdict tokens from previous tasks in a Notification step of a workflow. Learn more about configuring object and multi-document workflows.

Expand Sibling Record State Check Entry Action to All Applications Feature

The lifecycle entry action Check sibling records before updating related record is now available in all Vaults.

This entry action validates that all the siblings of a record are in the same state or group of states before changing the state of a related record. This functionality was previously available to Quality Vaults but is now available to all Vault applications. Learn more about configuring the sibling record state check entry action.

Update Expressions in Workflow & Lifecycle

This feature adds support for populating Picklist and Yes/No fields using lifecycle and workflow formulas. In addition, the user interface for defining formulas in document lifecycles and workflows is now consistent with object lifecycles and workflows.

Atomic Security for Active Workflow Actions in Objects

Active workflow actions in object workflows can now be secured based on lifecycle state and role. The securable actions are Cancel Workflow, Cancel Task, Reassign, Add Participants and Update Task Due Date.

Workflow initiators will continue to have access to these actions regardless of permission sets and Atomic Security. Learn more about Atomic Security for active workflow actions.

Reporting & Dashboards

Combine Dashboards Prompts

This feature combines dashboard prompts referencing the same object and using the same operator. For example, the Study > Country in… and Document > Country in… prompts both reference the Country object and use the in operator, so users will only select a country once.

Support Is Latest Version in Matched Document & Relationship Reports

This feature adds support for the Is Latest Version field in Matched Document and Document Relationship reports. This field is often used to understand whether a document has been superseded, and is currently available in other document reports.

Working with Documents

Enhancement to Import Document Links

To improve performance and reliability when a user performs the Import Document Links action, Vault now displays the latest version of documents for which the user has View Document permission and which contain at least one Linked Document relationship. Previously, Vault only displayed a document if it was the absolute latest version and had at least one Linked Document relationship.

New API Parameter for Adding Large Size Asset Renditions

As of 20R2.2, Vault will no longer automatically process files placed in the FTP Inbox. Users will instead upload files to any folder on the FTP, and then use the Vault REST API to upload renditions to the correct document. This feature also adds the new largeSizeAsset query parameter to the Add Multiple Document Renditionsendpoint, allowing users to add Large Size Asset type renditions with Document Migration Mode limitations even if the user does not have Document Migration permission.

Learn more in Uploading Renditions and Creating Staged Documents.

Read & Understood Download Button Visibility Update

Users who have a Read & Understood task to complete will now only see the Download button if their security profile includes the Download Rendition permission and they have a role on the document that includes the View Content permission. Learn more about Read & Understood document workflows.

Show Current Time in Overlays

This feature adds a new token ${currentTime__v} to display the current time and time zone on document overlays in order to provide a more compliant way to track documents exported from Vault. The token will be displayed in the user’s time zone. This new token, used along with the existing current date token, allows the overlay to capture the full date and time the rendition was downloaded from Vault. Learn more about managing overlays.

Cross-Document Links in Binders

This feature enables navigation of cross-document relative-path links within binders for links embedded in content and document bookmarks. Navigation relies on the target document’s location within the binder’s section structure. Vault displays the target document in a mini-browser review window, the contents of which refresh when the user clicks subsequent cross-document links. If the target resource does not exist in the defined location within the binder structure, Vault displays a “Document Not Found” message. Learn more about cross-document linking in binders.

Administration

Managing Sandbox Allowances

This feature enables Vault Admins to manage sandbox allowances across all their sandboxes. The Set Allowance action is available via UI and REST API to manage allowances. Vault Admins can view and interact with not only sandboxes created from the logged-in Vault, but also with any clone created from another sandbox.

Flexible Job Scheduling

This feature expands the options for scheduling jobs to allow hourly, daily, weekly, and monthly jobs. Previously, Admins could only schedule daily jobs from the Vault Admin UI.

SDK Job Administration

This feature enables Vault Admins to manage SDK Jobs through the new SDK Job Metadata UI.

Spark Field Rule Field Default Additional Data Type Support

Spark Field Rules for mapping fields now supports Number, Boolean, Date, Datetime, and Picklist (single and multiple) in the field defaults, supplementing the existing string and array data types. If the format is correctly entered, a field default can be persisted to a target object field of these data types.

Vault Configuration Report Enhancements

This feature introduces an updated UI for component and object data selection, as well as enhancements to the Excel cover page and table of contents for better readability. Learn more in Generating Vault Configuration Reports.

Configuration Migration Review & Deploy Performance Optimizations

This feature introduces performance optimization and pagination support for the Review & Deploy UI. In addition, Vault now includes the Description column in the default list layout of the Inbound Packages and Outbound Packages pages in Vaults where the default list layout has not been modified. This supports future functionality that will allow Outbound Package generation from Vault Compare. In Vaults with custom list layouts for these pages, we recommend adding the Description column manually. Learn more in Using Configuration Migration Packages.

Section Level Help

This feature allows object record details pages to have help content for each section. Admins can define this custom help content in the Add Section or Edit Section dialogs on the object page layout configuration page. Learn more in configuring object page layouts.

Vault Loader Bulk Remove Users from Document Roles

This feature adds support for bulk removal of users from document roles to the Vault Loader UI, Command Line Tool (CLI), and the Multi-File Load REST API. Learn more in Vault Loader: Update Document Roles.

OAuth Profiles: Enable Azure as a Standalone Authorization Server Type

This feature splits the Authorization Server Type configuration or ADFS / Azure AD on OAuth / OpenID Connect Profiles into two separate options: (1) ADFS, and (2) Azure AD. By default, all current configurations with Authorization Server Type set to ADFS / Azure AD, will receive a value of ADFS after this release.

Clinical Operations

Auto-Manage Principal Investigator Field on Study Site

This feature allows customers to auto-manage the Principal Investigator field on Study Site records with the use of the Study Person object. Learn more about creating study sites.

Auto-Populate Milestones from Subject Data

This feature automates the population of the Actual Finish Date field on first and last subject-related Milestone records at the site level. Last subject Milestones are not populated until the No New Subjects checkbox is set. Learn more about automated enrollment milestones.

Clinical Operations 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 Clinical Operations data model. These data model updates are automatically available on all Clinical Operations Vaults.

We have added the following components to support the Auto-Populate Milestones from Subject Data feature:

• No New Subjects (no_new_subjects__v) field to the Study Site (site__v) object
• Added the following values to the Milestone Type (milestone_type__v) picklist:
  • Last Subject Treated (last_subject_treated__v)
  • First Subject Treated (first_subject_treated__v)
  • First Subject Out (first_subject_out__v)

Commercial

Medical Inquiry: Cover Letter Generation Enhancements

This feature introduces the new Medical Inquiry Case Response Cover Letter document type. Users can choose to generate a cover letter using this document type to populate three document fields: Related Case, Related Case Request and Related Case Response. Fields on the particular Case Response record and related Case Request record are referenced as tokens in the document template.

Previously, the Generate Cover Letter function used the Medical Inquiry Cover Letter document type. For this document type, the Related Case document field is populated when the user action is run, which means that tokens in the template referencing Case Request and Case Response records retrieve every child Case Request and Case Response record under the parent Case Record and use Merge Fields to combine the token values.

Using the new document type prevents duplicated fields retrieved from multiple Case Request and Case Response records under a Case record by referring directly to the field on the Case Request or Case Response object. Learn more about Configuring Medical Inquiry.

Auto Claims Linking: Simple Version Binding on References

With this update, Vault no longer removes references from a Claim record when the targeted document is up-versioned. Once a user adds a reference to a specific version, it remains unmodified regardless of the creation of a new version of the document. This allows users to link to approved documents, and to keep those references to the Approved version intact when a subsequent Draft version is created and in review.

Note that Vault still removes references from Claim records when:

• A user deletes the targeted document version or anchor annotation.
• The target document enters a lifecycle’s Obsolete State.
• A target document’s document type configuration is changed to be ineligible as a target for suggested links.
• A target document’s document type is changed to a different document type that is ineligible as a target for suggested links.

Learn more about Using Auto Claims Linking.

Commercial 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 Commercial data model to support new features:

• Added new Medical Inquiry Case Response Cover Letter document type
• Added new document field Related Case Request (related_case_request__v) to the Case Request object
• Added new document field Related Case Response (related_case_response__v) to the Case Response object
• Added new field Document Version (document_version_id__v) to the Link Target object

Quality

Hide Training Report from Document Actions Menu

This feature hides the Training Report from the document Actions menu for customers who do not utilize Read & Understood functionality in Quality Vaults. This feature is enabled by Support, and the Training Report can be made available again through the document Actions menu if a customer later chooses to utilize Vault Read & Understood capabilities. Learn more about the Training Report.

Update MDCC Document Picker Dialog

With this release, we have updated the user interface shown when adding or removing documents in Multi-Document Change Control records.

Regulatory

Dynamic Filters in Content Plan Hierarchy Viewer

This feature extends filtering functionality in the Content Plan Hierarchy Viewer to support additional field types. Users can now apply filters to Picklist, Lifecycle State, and Object Reference columns. Learn more about applying filters in the Content Plan Hierarchy Viewer.

Support for Default Values in Field Rules

With this release, the eTMF & Submissions Spark Connection supports the inclusion of default values within the integration’s field rules. This allows for Admins to define explicit default values when there is no value defined for a field in the source Vault. Learn more about configuring the eTMF & Submissions Spark Connection.

Create Activities per Application

This feature adds an additional level of granularity when users create activities from an Event record using the Create Related Records wizard. Users can now create one activity per application, even if the application spans multiple products.

In previous releases, selecting the Application option activity scope level created one Activity record for each unique combination of Application and Product. The Application and Product activity scope level preserves this behavior.

Filter Grids & Select All in Manage Registered Details Wizard

This feature introduces the following enhancements to the Manage Registered Details wizard UI:

• Column filters on all grid pages; users can filter on Picklist, Yes/No, Lifecycle State, and Date fields, as well as Object fields that don’t reference complex join objects
• A Select All button that allows users to select all records in the grid
• On the Add New Details page, the Select Details button is relabeled to Add New Details

Pause RIM Registrations Vault Java SDK Triggers

Customers performing large migrations that do not wish to have the RIM Registrations Vault Java SDK triggers running can now pause these from the Application Settings page to prevent automatic record creation and updates. This allows for a smoother migration of data with Vault Loader or Vault API. When the Registrations Vault Java SDK Record Triggers are paused, Vault will not automatically create or update the following records:

• Country Decision Details: Vault will not automatically create Country Decision Detail records or update the Country Decision Detail Count field on the Regulatory Objective records.
• Administered Product: Vault will not automatically create Administered Product Active Substance or Administered Product Inactive Ingredient records for Administered Product records of object type Administered as Manufactured.

Learn more about pausing the Registrations Vault Java SDK triggers.

Submissions Archive: Jordan 1.1

With this release, RIM Submissions Archive Vaults support importing and viewing eCTD submissions based on the Jordan v1.1 DTD.

FTP Folder Selection Update

This update allows users to maintain more contextual object record names in Vault while more accurately locating submissions on FTP. When users import submissions via FTP, Vault now leverages the selected dossier format parameters to match the folders on FTP. If the dossier format has not been defined, Vault will use the Application Folder Name or Sequence ID, when populated, before relying on the Application and Submission record names. Learn more about preparing submissions for import.

Submissions Archive Ordering Update

With this release, Vault will now display newly-imported submission eCTD files above the eCTD section. Vault will also order non-eCTD submissions based on the date in the Actual Submission Date field. If the Actual Submission Date field is blank, Vault will order these submissions based on the date and time of the import instead. Vault will then order submission content alpha-numerically.

China eCTD XSD 1.0 Publishing & Validation

Given recent changes to the eCTD specification made by the China NMPA, this feature has been postponed to a later release.

Jordan eCTD DTD 1.1 Publishing & Validation

With this release, RIM Submissions Publishing Vaults support the Jordan (JO) JFDA v1.1 (DTD 1.1) specification. Users can now create content plans and generate submissions that are compliant with JO JFDA 1.1 specifications. Vault validates these submissions based on the corresponding JO JFDA 1.1 Validation Criteria. Learn more about working with Jordan regulatory submissions.

Publishing Improvements for Split Content Plan Items

When continuous publishing is enabled on Vaults with Submissions Publishing, Vault now runs an on-demand publishing job on the parent content plan once the Split Content Plan Item user action completes. Learn more about splitting content plan items.

20R3 Regulatory Data Model Updates

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 Regulatory data model to support features in a future release:

Expand this section to view Regulatory Data Model Updates.

Safety

Safety features are targeted for tentative availability on August 27, 2020.

Automatic Email of Case Questionnaire & Scheduled Reminders Support

Vault Safety can now automatically send questionnaires to a reporter by email depending on the product, country, language, and watchlist. Vault Safety will also send reminders to the reporter a specified number of times at a specified interval. Vault Safety can also track whether these emails are delivered and opened.

Learn More:

• For user help, see Send a Follow-Up Email Questionnaire to a Case Reporter
• For Admin help, see Set Up Scheduled Follow-Up Questionnaire Emails

Auto-Submissions Support

Vault Safety can now submit multiple ICSR files to the gateway destination directly from the Case. Once reporting obligations are evaluated for a Case, users can submit at the Case level without having to navigate to each Submission or Distribution.

Once the feature is enabled, administrators can configure at the Transmission Profile level which agencies and distribution partners qualify for auto-submission.

Learn More: Auto-Submissions

VAERS Submission Support

Vault Safety now supports the capture, tracking, and submissions of ICSRs with suspect or interacting Vaccine-type products to the Food and Drug Administration (FDA). Submissions are supported through the FDA CBER VAERS Gateway, using a new FDA VAERS E2B(R3) file format.

As part of this feature, Vault Safety’s data model was extended to new fields to capture the data required for VAERS submissions.

Learn More:

• For FDA VAERS E2B(R3) export mapping, see E2B Generation Data Mapping: FDA VAERS E2B(R3) Mapping
• For descriptions of new fields, see Enter Case Data
• For Admin setup of the VAERS FDA Gateway and Transmission Profile, see Configure FDA Gateway

Vaccine Case Entry and EMA/UK Vaccines Submission Support

Vault Safety now supports the capture, tracking, and submissions of ICSRs with suspect or interacting Vaccine-type products to the European Medicines Agency (EMA).

Product and Medical Event Auto-Classification Auto-on

Safety.AI attempts to classify products (case product or drug history) and medical events (adverse event or medical history) to help intake users triage and verify product and event information. The system can classify the product drug role as drug history, suspect, interacting, concomitant, treatment, or not administered. The system can classify the medical event type as concurrent condition, adverse event, or medical history. Users can verify and edit the product and event type when they verify the Inbox Item.

The system creates the appropriate Case Product or Drug History records, and Adverse Event or Medical History records, based on the drug role and event type respectively, when the Inbox Item is promoted to an AER.

Case Contact Classification Auto-on

Vault Safety.AI API will ingest structured contact information for reporters, patients, and other contacts. While entering and verifying data, Safety.AI allows users to classify case contact types, including differentiating between reporters and the patient.

Inbox Item Security and Audit Trail Auto-on

Safety.AI enforces Vault security around Inbox Items, including Permission Sets, Lifecycle State, and Atomic security, to ensure only authorized users can access Inbox Items. Users must be assigned the API Vault Action permission to be able to create Inbox Item records for any sponsor organizations by calling the Intake API. In addition, Safety.AI automatically compiles an audit trail that logs actions on Inbox Item records and sections, as well as Create AER actions.

Manual AER Intake Auto-on

You can manually create Inbox items as an alternative to automated intake through the API.

New Product and Reporter Fields for Case Intake Auto-on

Vault Safety.AI now supports Product Indication and Batch/Lot Number intake. The Intake API will accept these fields in the JSON structured data that will be presented in Product sections of the Inbox Item user interface.

Enablement Details

Name	Enablement	Application
Lifecycle & Workflow
Object & Multi-Document Workflows: Update Task Due Date	Auto-on	Platform
Object & Multi-Document Workflows: Ad Hoc Task Instructions	Configuration	Platform
Object & Multi-Document Workflows: Update Sharing Settings in Task Step	Configuration	Platform
Object & Multi-Document Workflows: Additional Task & Workflow Initiator Tokens	Configuration	Platform
Expand Sibling Record State Check Entry Action to All Applications	Configuration	Platform
Update Expressions in Workflow & Lifecycle	Auto-on	Platform
Atomic Security for Active Workflow Actions in Objects	Configuration	Platform
Reporting & Dashboards
Combine Dashboards Prompts	Auto-on	Platform
Support Is Latest Version in Matched Document & Relationship Reports	Auto-on	Platform
Working with Documents
Enhancement to Import Document Links	Auto-on	Platform
New API Parameter for Adding Large Size Asset Renditions	Auto-on	Platform
Read & Understood Download Button Visibility Update	Auto-on	Platform
Show Current Time in Overlays	Configuration	Platform
Cross-Document Links in Binders	Auto-on	Platform
Administration
Managing Sandbox Allowances	Auto-on	Platform
Flexible Job Scheduling	Configuration	Platform
SDK Job Administration	Configuration	Platform
Spark Field Rule Field Default Additional Data Type Support	Auto-on	Platform
Vault Configuration Report Enhancements	Auto-on	Platform
Configuration Migration Review & Deploy Performance Optimizations	Auto-on	Platform
Section Level Help	Configuration	Platform
Vault Loader Bulk Remove Users from Document Roles	Auto-on	Platform
OAuth Profiles: Enable Azure as a Standalone Authorization Server Type	Auto-on	Platform
Clinical Operations
Auto-Manage Principal Investigator Field on Study Site	Auto-on	CTMS, Study Startup, Vault Payments, eTMF
Auto-Populate Milestones from Subject Data	Admin Checkbox	CTMS
Clinical Data Model Changes	Auto-on	CTMS, Study Startup, Vault Payments, eTMF
Commercial
Medical Inquiry: Cover Letter Generation Enhancements	Configuration	MedComms
Auto Claims Linking: Simple Version Binding on References	Auto-on	PromoMats
Commercial Data Model Changes	Auto-on	MedComms, PromoMats
Quality
Hide Training Report from Document Actions Menu	Support	Quality
Update MDCC Document Picker Dialog	Auto-on	QualityDocs
Regulatory
Dynamic Filters in Content Plan Hierarchy Viewer	Auto-on1	RIM Submissions
Support for Default Values in Field Rules	Configuration	RIM Submissions
Create Activities per Application	Auto-on	RIM Registrations
Filter Grids & Select All in Manage Registered Details Wizard	Auto-on	RIM Registrations
Pause RIM Registrations Vault Java SDK Triggers	Admin Checkbox	RIM Registrations
Submissions Archive: Jordan 1.1	Auto-on	RIM Submissions Archive
FTP Folder Selection Update	Auto-on	RIM Submissions Archive
Submissions Archive Ordering Update	Auto-on	RIM Submissions Archive
China eCTD XSD 1.0 Publishing & Validation	Support	RIM Publishing
Jordan eCTD DTD 1.1 Publishing & Validation	Configuration	RIM Publishing
Publishing Improvements for Split Content Plan Items	Auto-on	RIM Publishing
20R3 Regulatory Data Model Updates	Auto-on	RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive

1. In Vaults with the Content Plan Hierarchy Viewer enabled.

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.