Vault CDMS Release Impact Assessment...19R3 Release Impact Assessment The Release Impact Assessment (RIA) documents the new capabilities released in this Vault CDMS release that may

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


Yes Vault Coder no longer displays TherapeuticArea in the application as there is no way toconfigure this outside of Admin > BusinessAdmin.



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


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.



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.


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.



Data Managersuse this feature


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.


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.


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.


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.


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.


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.


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.


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



Type property to ease design definitioncreation in Studio.


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.


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.


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.


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.

Documents

Vault CDMS Release Impact Assessment...19R3 Release Impact Assessment The Release Impact Assessment (RIA) documents the new capabilities released in this Vault CDMS release that may