19R3 Release Impact Assessment
The Release Impact Assessment (RIA) documents the new capabilities released in this Vault CDMS release that may affect a customer's vault. Refer to the Enablementand Default Impact for each feature to determine the visibility and configuration requirements.
This feature list is subject to change prior to the release. We will begin tracking changes on: 10/25/2019
Revision Date: 1/31/2020
VIA Available: 11/18/2019
This document does not include changes made as part of the Vault Platform release. Consult Veeva Docs for Vault Platform validation details.
Feature Risk: Feature risk analysis takes into account data integrity, security, and confidentiality assuming the feature is turned on (eitherautomatically or via configuration). Veeva performs validation testing on all High and Medium risk items.
High May affect security, patient confidentiality, application areas that support GXP functions (audit trails, eSignature, etc.) or other EREScontrols data
Medium May affect core application functions (workflows, revision history, etc.)
Low May affect metadata/notifications
N/A The feature is a minor UI enhancement and not a functional change. The feature has no validation impact.
Enablement: Indicates whether the feature is available automatically, requires some configuration, or must be enabled by Veeva Support.
Auto-on This feature is available automatically in its application area.
By Study Build The options to configure this feature display automatically, but it must be configured as part of a study to be visible to other users.
Study Feature Flag This feature must be enabled on each study's configuration by Veeva Services.
Support This feature must be enabled by Veeva Support.
Vault CDMS Release Impact Assessment Page 2 of 7
Application Impacted Areas Feature Name Feature Risk Enablement Training Impact Existing Studies Description
All Coding, CodingAdministration,Study Design &Configuration
"Other" Option forCoding Form Type
Low By Study Build Study Designer No When using "Other" for Form Type, Studiousers can now select relevant Related Itemsbased on their chosen dictionary type(WHODrug or MedDRA).
All Deployments,CodingAdministration,StudyAdministration,Study Design &Configuration
AutomatedDeployments
High Support *Existingstudies mustundergo anupgrade process(via VeevaServices) to usethe newdeployment model.
UserAdministrator,Lead DataManager, StudyDesigner,DeploymentAdministrator
No With automated deployments, sponsors canmove a study build from development to theirUAT, training, and production environmentswithout repeated exports and imports orduplicate configuration.
All Deployments,CodingAdministration,Study Design &Configuration
Ability to Change theDictionary Type for aForm
Medium Support *Thelockedconfiguration andReconstitute CodeRequests jobdisplayautomatically, buta study designermust work withVeeva Services touse this feature.
Study Designer,Lead DataManager
No Studio users can now work with VeevaServices to update the Dictionary Releasetype, or independently update other codingconfiguration, for a coding Form after CodeRequests already exist. Then, using theReconstitute Code Requests job, anadministrator can recreate those CodeRequests referencing the updatedconfiguration.
All CodingAdministration,Study Design &Configuration
Select DictionaryReleases from Only theDictionary Database
Low Auto-on Clinical CoderAdministrator,Study Designer
Yes *If a userupversions adictionary orupdates a Form'sconfiguration
All Dictionary Release drop-down menus nowonly show Dictionary Releases from theDictionary Database, instead of any dictionaryrelease records in the vault, providing easyaccess to the latest dictionary release.
All StudyAdministration
New PermissionsAvailable for RoleManagement
Medium Auto-on *In vaultswhere Role byStudy is enabled
UserAdministrator,Lead DataManager
Yes *Thesepermissions areassigned toexisting,standard StudyRoles
With this release, we added two newpermissions, "View Casebook" and "DesignStudy".
Coder Coding Dictionary SearchEnhancements
Low Auto-on Clinical Coder,Clinical CoderAdministrator
Yes With this release, we updated DictionarySearch so that it retrieves results morequickly and with search terms in any order.
Coder Coding Removed TherapeuticArea from Coder
Low Auto-on Clinical Coder,Clinical CoderAdministrator
Yes Vault Coder no longer displays TherapeuticArea in the application as there is no way toconfigure this outside of Admin > BusinessAdmin.
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Application Impacted Areas Feature Name Feature Risk Enablement Training Impact Existing Studies Description
Coder Coding, CodingAdministration
Extend Coding Decisionto All Forms & Updatethe Synonym List
Medium Auto-on Clinical Coder,Clinical CoderAdministrator
Yes *If Codersuse this feature
Coders can use the new Code All Forms andUpdate Synonym Lists action to apply theircoding decision to the current Code Request,Code Requests for all matching Forms, andany matching records in the Synonym List.
Coder Coding, CodingAdministration
Coder UIEnhancements
Low Auto-on Clinical Coder,Clinical CoderAdministrator
Yes With this release, we made the following UIenhancements to Vault Coder: we renamedStop Lists as Do Not Autocode Lists; theCode Request listings page nowautomatically sorts Code Requests byVerbatim and coding properties; and weadded a search to the Synonym List Detailspage in Coder Tools.
Coder Reports &Dashboards
Enhanced CoderMetrics
Low Auto-on Clinical CoderAdministrator,Clinical Coder
Yes *If usersview thesereports
We added the Last Coded By field to theMedical Coding Request object and the LastQueried By field to the Medical CodingRequest Query object to allow users to createreports and dashboards related to codingprogress and query status in Coder.
EDC Assessments,StudyAdministration,Study Design &Configuration
Clinical ReviewAssessments
Medium By Study Build *Invaults where Roleby Study isenabled
AssessmentReader, LeadData Manager,Study Designer,AssessmentEditor
No Studies can now collect additional dataoutside of Casebooks as "assessments".
EDC Data Entry, DataReview
Audit TrailEnhancements
High Auto-on Data Manager,Auditor ReadOnly, ClinicalResearchCoordinator, SubInvestigator,Clinical ResearchAssociate,Investigator, LeadData Manager
Yes With this release, we made the followingenhancements to the audit trail: we updatedthe action labels for accessing the audit trailto "{Object} Audit Trail"; we now display thesignature meaning for audit events related tosignatures; and we now include seconds inthe time for an audit event.
EDC Data Entry, DataReview
Sticky Filters in the DataEntry & Review Tabs
Low Auto-on Data Manager,Auditor ReadOnly, ClinicalResearchCoordinator, SubInvestigator,Clinical ResearchAssociate,
Yes When a user applies a filter to a listing page,Vault remembers those applied filters for theduration of the user's login session.
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Application Impacted Areas Feature Name Feature Risk Enablement Training Impact Existing Studies Description
Investigator, LeadData Manager
EDC Data Entry, DataReview, StudyAdministration
Detail PDFEnhancements
Medium Study FeatureFlag
Sub Investigator,Clinical ResearchAssociate, DataManager,Investigator, LeadData Manager,Clinical ResearchCoordinator
No We made the following enhancements toDetail PDFs: each page now includes a tableheader providing information about the form;the PDF includes bookmarks; if the PDFincludes the audit trail, it now has Audit Trailby Visit and an Audit Trail by Form sectionswith bookmarks; and if the PDF includesqueries, it now has a Queries section with abookmark.
EDC Data Review Review UIEnhancements
Low Auto-on *In vaultswhere the Reviewtab is enabled
Clinical ResearchAssociate, DataManager, AuditorRead Only, LeadData Manager
Yes We made the following enhancements to theReview tab: users can filter by Site Number inStudy Sites and Queries with the Site # filter;Vault shows help content for Forms and Itemsin a tooltip.
EDC Data Review,Reports &Dashboards, StudyAdministration
Removed SDV & DMRPropagation
Medium Auto-on *Thisfeature is notavailable forexisting Studies.
Clinical ResearchAssociate, LeadData Manager,Data Manager
No *This featureis not availablefor existingStudies.
In studies created after 19R3, Vault no longerpropagates the SDV and DMR status.Instead, Vault tracks review statuses usingReview State records. This change does notaffect studies created before 19R3.
EDC Reports &Dashboards
Track Queries Leadingto Data Changes
Medium Auto-on UserAdministrator,Data Manager,Clinical Coder,Clinical ResearchAssociate,Clinical CoderAdministrator,Lead DataManager, StudyDesigner
Yes *If a userviews this report
Vault EDC now tracks whether or not a querycaused a user to change an Item value withthe new Query Summary object. Users canreference this object in reports to gatheroperational data related to query efficiency.
EDC StudyAdministration,Reports &Dashboards
Allow AdministratorUsers to ScheduleReports
Medium Auto-on Clinical CoderAdministrator,Lead DataManager
Yes *If theseusers choose toschedule reports
Lead Data Managers and Clinical CoderAdministrators can now schedule flashreports with the new "Schedule Reports"permission.
EDC StudyAdministration
Bulk Update the ActiveVersion for Sites
Medium Auto-on Lead DataManager
Yes *If LeadData Managersuse this feature
EDC Tools users can now update the ActiveVersion for multiple Sites with one action.
EDC StudyAdministration
Compare CasebookVersions from EDCTools
Medium Auto-on Lead DataManager
Yes *If Lead EDC Tools users can now compare singlecasebook versions. The comparison report isthe same report available from Studio.
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Application Impacted Areas Feature Name Feature Risk Enablement Training Impact Existing Studies Description
Data Managersuse this feature
EDC StudyAdministration
Core Listings Low Auto-on Lead DataManager
Yes *If a LeadData Managerruns the job
EDC Tools users can export a formatted CSVof execution data for selected Forms andSites with the new "Data Listing" job.
EDC StudyAdministration
Display the Number ofUsers Assigned a StudyRole
Low Auto-on *In vaultswhere the Role byStudy feature isenabled
UserAdministrator,Lead DataManager
Yes Vault now displays the number of Usersassigned a Study Role in Tools > RoleManagement.
EDC StudyAdministration
Relabeled Connectionsas FTPs
Low Auto-on Lead DataManager
Yes *The labelchange is visibleto all EDC Toolsusers
With this release, we relabeled theConnections tab in EDC Tools as FTPs.
EDC StudyAdministration
Enablement Change:ProspectiveAmendments
Low Support Lead DataManager
No With this release, we updated the enablementof prospective amendments from auto-on tosupport. Organizations must now contactVeeva Support and request that prospectiveamendments be enabled in their vault. Thischange applies to existing vaults.
EDC Study Design &Configuration
Compare All Versions inStudio
Medium Auto-on Study Designer Yes *If StudyDesigners usethis feature
Studio users can now compare all existingversions of a Study to all versions of anotherStudy, instead of comparing versions one byone.
EDC Study Design &Configuration
Compare Forms AcrossStudies
Medium Auto-on Study Designer Yes *If StudyDesigners usethis feature
Users can now compare only the Forms in aStudy to the Forms in another Study.
EDC Study Design &Configuration
New Studio NavigationPattern
Medium Auto-on Study Designer Yes *If anorganization isusing Studio
With this release, we refreshed andrearranged the Studio user interface to makeit smoother and easier to use. Users can nowimmediately select a Study upon openingStudio, and the original Studio subs havebeen moved into a side navigation panel.
EDC Study Design &Configuration
Set Blank Handlingfrom Rule Editor
Medium Auto-on *This fielddisplaysautomatically, butit isn't populatedfor existing Rules
Study Designer No Studio users can now determine how a rulehandles blank values from the Rule Editor.Previously, this setting was only available inAdmin > Business Admin.
EDC Study Design &Configuration
Studio UsabilityEnhancements
Medium Auto-on Study Designer Yes *If anorganization isusing Studio
We updated the New Event Group, NewEvent, and New Form dialogs, updateddefault property values, and moved the Data
Vault CDMS Release Impact Assessment Page 6 of 7
Application Impacted Areas Feature Name Feature Risk Enablement Training Impact Existing Studies Description
Type property to ease design definitioncreation in Studio.
EDC Study Design &Configuration
Study DocumentationEnhancements
Medium Auto-on Study Designer Yes *If a StudyDesigner usesthis feature
We added new annotations for annotatedPDFs and new values to the Study DesignSpecification to show more information abouta study design in these documents.
EDC Study Design &Configuration
Set Subject Status withRules
Medium By Study Build *InStudies usingVersion 2 of theexpressiongrammar
Study Designer No Studio users can create rules to change asubject's Status based on entered data.
EDC Study Design &Configuration
Send Emails with Rules Low By Study Build Study Designer No Studio users can create a rule to send aconfigured email notification to a group ofstudy users. Note that in the current release,rule configuration for Send Email rules mustbe performed primarily in Admin > BusinessAdmin by a Veeva Services team member.
Vault CDMS Release Impact Assessment Page 7 of 7
Change Log
This feature list is subject to change prior to the release. We will begin tracking changes on: 10/25/2019
Date Description Impact
10/21/2019 Published the initial version of the RIA N/A
10/26/2019 Removed the "Enablement Change: Vault Coder Dashboards &Reports" feature
The RIA now has an up to date list of features for release in 19R3.
10/29/2019 Renamed the "Simple Listings" feature as "Core Listings" The RIA now includes up to date feature names.
10/30/2019 Removed the "JReview® Integration" and "Veeva LearningIntegration" features. These features were postponed to a laterrelease.
The RIA now includes an up to date list of features for release in 19R3.
11/5/2019 Updated the enablement of "Clinical Assessments" from "By StudyBuild" to "By Study Build *In vaults where Role by Study is enabled"
The RIA now has up to date enablement information.
11/11/2019 Updated the name of "Ability to Change the Dictionary for a Form" to"Ability to Change the Dictionary Type for a Form"
The RIA now includes up to date feature names.
11/18/2019 Updated the description for the '"Other" Option for Coding FormType' feature
The RIA now includes up to date feature descriptions.
11/20/2019 Updated the description for the "Track Queries Leading to DataChanges" feature
The RIA now includes up to date feature descriptions.
11/20/2019 Updated the description for the "Send Emails with Rules" feature The RIA now includes up to date feature descriptions.
1/31/2020 Updated the name of "Clinical Assessments" to "Clinical ReviewAssessments"
The RIA now includes up to date feature names.