Vault CDMS Release Impact Assessment · forms through Form Linking in the Data Entry and Studio tabs. For example, an Adverse Event form can be linked to one or more Concomitant Medication

20R1 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: 3/9/2020

Revision Date: 4/9/2020

VIA Available: 3/30/2020

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 9

Application Impacted Areas Feature Name Feature Risk Enablement Training Impact Existing Studies Description

All Deployments,Vault Tools, DataReview, CodingAdministration,StudyAdministration,Study Design &Configuration

All Vault CDMSNotification EmailsUse Vault CDMSLogo

N/A Auto-on UserAdministrator,Data Manager,Clinical ResearchAssociate,Clinical CoderAdministrator,VaultAdministrator,Lead DataManager, StudyDesigner,DeploymentAdministrator

Yes *Users whoreceivenotifications willsee this changein anynotificationsreceived after therelease.

All email notifications from Vault CDMS nowuse the Vault CDMS application logo.

All Deployments,StudyAdministration

AutomatedDeployments IncludeCustom Study Roles& Objects

Medium Auto-on **The newoptions fordeploymentsdisplayautomatically todeploymentadministrators, buta Vault Ownermust first createDeploymentWhitelist recordsfor those optionsto be useable.

DeploymentAdministrator

No *While thenew deploymentoptions displayautomatically, aVault Ownermust whitelistcustom StudyRoles andobjects beforethey can beincluded in adeployment.

Deployment administrators can choose toinclude custom Study Roles and customobject configuration in their studydeployments. A Vault Owner must first addStudy Roles and custom objects to theDeployment Whitelist for those to be includedin deployments.

All Deployments,StudyAdministration

Create a ProductionEnvironment fromEDC Tools afterStudy Creation

Medium Auto-on *Instudies using theautomateddeployment model

DeploymentAdministrator

No *If aproductionenvironmentalready exists,another one can'tbe created.

Deployment administrators can now create aproduction-type environment from EDC Tools.

All StudyAdministration

Changes to theManage UsersPermission & CDMSUser AdministratorRole

High Auto-on *In vaultswhere Role byStudy is enabled

UserAdministrator

Yes The "Manage Users" permission no longergrants the ability to edit and delete StudyCountries and Sites. We then added the"Manage Study Countries" and "ManageStudy Sites" permissions to the standardCDMS User Administrator study role.


New "Manage StudyRole" Permission


UserAdministrator,Lead DataManager

Yes *Any usersassigned thesestandard roleswill have this

With this release, we added a newpermission, Manage Study Roles, whichprovides the ability to create and edit customStudy Roles in Tools > Role Management.



new permission. This permission is assigned to the CDMSLead Data Manager and CDMS UserAdministrator standard roles.


New "View Coding"Permission


UserAdministrator,Lead DataManager, StudyDesigner

Yes *Thispermission isautomaticallyassigned toexisting standardStudy Roles andany custom rolesthat have accessto Coder tab.

This release added the new "View Coding"permission, which controls the ability to viewcoding progress, without impacting items thathave already been coded. By default, thispermissions is assigned to the CDMS ClinicalCoder, CDMS Clinical Coder Administrator,and CDMS Study Designer study roles, aswell as any custom Study Roles that haveaccess to the Coder tab.


Provide Federated IDduring User Creation(UI)

High Auto-on UserAdministrator

No *Recordsmust be edited touse this newfield.

When creating and editing users from EDCTools > Users, user administrators can nowprovide a Federated ID. Vault uses theFederated ID to connect with a Single SignOn application.


Separated SecurityProfiles for DataEntry Study Roles

High Auto-on *The newsecurity profilesare available bydefault, but theyare not assignedto any existinguser accounts.

VaultAdministrator

No *Existingusers with theCDMS DataEntry securityprofile will stillhave that profileassigned.

With this release, we added separate securityprofiles, intended to replace the standard"Data Entry" profile: "CDMS PrincipalInvestigator", "CDMS Sub Investigator", and"CDMS Clinical Research Coordinator".


User Activity Report High Auto-on UserAdministrator,Lead DataManager

Yes *Users withpermission cangenerate thisreport.

EDC Tools users can track various useractions such as user logins, password resets,and users that have been created as well asstudy access changes like LMS trainingstatus, study/site access, and study roles,using the User Activity Report.


Veeva LearningTraining Report

High Auto-on *InStudies where theVeeva LearningIntegration isenabled


Yes *In Studieswhere the VeevaLearningIntegration isenabled

Users with access to EDC Tools > LearningSystems can generate a Training Report thattracks the progress of all study users throughtheir assigned training curricula.


Manage CustomObject Permissions inRole Management

High Configuration *Invaults where Roleby Study isenabled


No *Even if thereare qualifyingcustom objects,a Vault Ownermust first

User administrators and lead data managerscan now mange Read, Edit, and Deletepermissions for qualifying, whitelisted, customobjects from Tools > Role Management.



whitelist thoseobjects for themto appear.


Allow Deletion ofCustom Study Roles

Medium Auto-on *In vaultswhere Role byStudy is enabled


No *A useradministrator orlead datamanager mustinitiate thedeletion action touse this feature.

With this release, users with access to Tools> Role Management can delete any customStudy Roles, as long as the role is notcurrently assigned to any users.


Download Study RoleMatrix as an Excel™File

Low Auto-on *In vaultswhere Role byStudy is enabled


Yes *Any userwith access toTools > RoleManagement cannow downloadthis file.

Role Management users can download anExcel™ file with the mappings of permissionsto their custom Study Roles.

All StudyAdministration,Study Design &Configuration

Study Designer RoleEnhancements


UserAdministrator,Lead DataManager, StudyDesigner

Yes *For anystudies using theCDMS StudyDesigner Role

We updated the CDMS Study Designer roleto leverage Matching Sharing Rules. Weadded the CDMS Study Designer Read Onlystudy role to assign to study designers inUAT, training, and production environments.The CDMS Study Designer study role is nowonly available in development environments.

All Study Design &Configuration

ODM Import & Exportfor AutomatedDeployment Studies

Medium Auto-on *In studiesusing automateddeployments

Study Designer No *A studydesigner mustinitiate the importor export processto use thisfeature.

ODM import and export functionality isavailable for use in automated deploymentStudies.

Coder, EDC Coding, CodingAdministration,StudyAdministration

Automating theAutocoding andSuggestions Job

High Auto-on Clinical Coder,Clinical CoderAdministrator,Lead DataManager

Yes The Autocoding & Suggestions job has beenchanged into an active and automatedprocess that runs throughout the day,providing the user with Autocoding andSuggestions that are constantly up-to-datewith evolving Synonym Lists. Autocoding jobscan no longer be scheduled and any currentlyscheduled Autocoding jobs will be cancelledwith this release. Vault Coder shows an Outof Sync notification as autocoding runs in thebackground. Coders can click the newRefresh button to refresh the page and seethe most up to date coding information. As



part of this feature, we removed theautoassign option.

Coder, EDC Data Entry, DataReview, Coding,Study Design &Configuration

Form Linking & Copyfrom Indication

Medium By Study Build *Instudies usingautomateddeployments andversion 2 of theexpressiongrammar

Sub Investigator,Clinical Coder,Clinical CoderAdministrator,Investigator,Study Designer,Clinical ResearchCoordinator

No *A studydesigner mustadd form linkingto a study'sdesign.

Users can configure and associate relatedforms through Form Linking in the Data Entryand Studio tabs. For example, an AdverseEvent form can be linked to one or moreConcomitant Medication forms that arerelated to that Adverse Event so as to groupsimilar or related data or indicate cause andeffect.

The Indication item on WHODrug-basedforms can also be further configured toretrieve Indication values from other formrecords.

Coder, EDC N/A AdditionalRequirements forCore Listings

N/A N/A N/A N/A With this release, we introduced new BRDsfor the Core Listings feature. There weren'tany functional changes to Core Listings.These new requirements were only added toprovide additional detail in the BRD.

Coder, EDC N/A AdditionalRequirements for theJReview® Integration

N/A N/A N/A N/A With this release, we introduced new BRDsfor the JReview® feature. There weren't anyfunctional changes to the JReview®integration. These new requirements wereonly added to provide additional detail in theBRD.

EDC Data Entry Allow Deletion ofSigned, DynamicForms

Medium Auto-on Investigator Yes *A user mustdelete a signedForm for thesechanges to bevisible.

Users can now edit a controlling Item (orreset the Form containing that Item) even iftheir change removes a dynamically addedForm that was already signed.

EDC Data Entry Data Entry NavigationEnhancements

Low Study FeatureFlag *Enabled bysetting "Data EntryVersion" in StudyConfig to blank

Sub Investigator,Investigator,Clinical ResearchCoordinator

No *This featuremust be enabledfor a study.

The Casebook Schedule page has beencombined with the Form Display page tocreate a better navigational experience for theuser. All Events and Forms in the StudySchedule are now displayed next to the Formpanel, allowing Data Entry users to navigateto any Form within any Event. Any activitiespreviously performed by CRAs or DMs (SDV,DMR, Freeze, Lock, etc.) will now need to beperformed in the Review tab.

EDC Data Entry, Data Prevent Recreation of Medium Auto-on Sub Investigator, Yes *This Vault no longer recreates system queries if



Review Manually ClosedSystem Queries

Clinical ResearchAssociate, DataManager,Investigator, LeadData Manager,Clinical ResearchCoordinator

change appliesto all existing andfuture queriesupon the release.

the same system query (same Rule and datapoint) was previously opened and thenmanually closed.

EDC Data Entry, DataReview, StudyDesign &Configuration

Item Indentation Low By Study Build Data Manager,Clinical ResearchCoordinator, SubInvestigator,Clinical ResearchAssociate,Investigator, LeadData Manager,Study Designer

No *A studydesigner mustadd thisconfiguration to astudy.

Study designers can indent Items on a Formusing the new Indent Level property.

EDC Data Entry, StudyDesign &Configuration

Prevent Creation ofFirst Instance forRepeating FormsAdded by an AddForm or Add EventRule

Medium Auto-on Sub Investigator,Investigator,Study Designer,Clinical ResearchCoordinator

Yes With this release, Vault no longerautomatically creates the first instance of arepeating Form if the Form is added by anAdd Form or Add Event rule. For existingStudies that want to continue with the originalbehavior or adding the first instance, a VaultAdministrator can set the Dynamic RepeatingForm Instance field on the StudyConfiguration object to "No".

EDC Data Entry, StudyDesign &Configuration

Progressive Display Medium Study FeatureFlag *In studiesusing automateddeployments andversion 2 of theexpressiongrammar

Sub Investigator,Investigator,Study Designer,Clinical ResearchCoordinator

No *A studydesigner mustadd thisconfiguration to astudy.

Study designers can design a form such thatdata collection items are dynamicallydisplayed or hidden as a user progressesthrough a form.

EDC Data Review,StudyAdministration

Site-level SDV &DMR Re-assignment

Medium Auto-on Lead DataManager

Yes *A lead datamanager can runthe jobimmediately afterthe release.

EDC Tools users can now run the SDV andDMR Re-assignment jobs at the Site level.

EDC StudyAdministration

Removed "ManageStudy Lock"Permission fromCDMS DeploymentAdministrator


UserAdministrator,DeploymentAdministrator,Lead DataManager

Yes *This featureremoves apermission froma standard StudyRole.

With this release, we removed the ManageStudy Lock permission from the standardCDMS Deployment Administrator study role.




Vault EDC/CTMSConnection withSpark

High Configuration Lead DataManager

No *This featuremust be enabledfor the vault.

This feature allows customers using bothVault EDC and Vault CTMS applications toconnect those vaults for the purpose oftransferring Studies, Study Countries andSites from Vault CTMS to Vault EDC andSubjects, Subject Visits and Visit Definitionsfrom Vault EDC to Vault CTMS using VeevaVault Spark Messaging.


Add Study Countriesduring Site Creation

Low Auto-on Lead DataManager

No *Users mustcreate a new Siteto see thischange.

EDC Tools users can now add StudyCountries when creating a new Site withoutleaving the New Study Site dialog.

EDC StudyAdministration,Study Design &Configuration

Send Email RuleConfiguration

Medium By Study Build*Send Email rulesare only availablein vaults usingRole by Study andstudies using theautomateddeployment model.

Lead DataManager, StudyDesigner

No *A studydesigner andlead datamanager mustconfigure a SendEmail rule andEmail Group.

With this release, Send Email rules and EmailGroups can now be fully configured fromStudio and EDC Tools. This feature addedthe Manage Email Group Assignmentspermission, which is automatically assignedto the CDMS Lead Data Manager study role.

EDC Study Design &Configuration

Choose StudyTemplate ReviewPlans in Studio

Medium Auto-on Study Designer Yes *Studydesigners cansee the newoptions rightaway.

Study Designers can select which reviewplans should be used as a default template tooverride SDV and DMR plans at the studylevel.


Copy Rules fromAnother Study

Medium Auto-on Study Designer No *A Studiouser must initiatethe copy processto use thisfeature.

Studio users can copy rules from anotherStudy. Vault validates all identifiers in thecopied rules and shows an indicator when arule contains an invalid identifier.


New Functions in theFormula ExpressionGrammar

Medium Auto-on *In studiesusing version 2 ofthe expressiongrammar

Study Designer No *Studydesigners mustcreate rulesusing these newfunctions.

This feature (1) introduces new functions:Power(), Sum(), Average(), and StartOfDay()to Vault Formulas, and (2) enhances Today()to take an optional timezone parameter.


Reciprocal Rules Medium Auto-on Study Designer Yes *Thischange appliesto all Rules.Organizationscan work with

Rules created after 20R1 are considered"reciprocal", and so rules for any Itemsreferenced as part of an @Form identifiernow apply to any use of the Form in aCasebook, even if that form isn't repeating.



Veeva Servicesto returnindividual rules totheir previousstate if required.


Status Change Datefor Set Subject StatusRules

Medium By Study Build Study Designer No *Existing SetSubject Statusrules willcontinue tofunction withouta date.

Study designers can configure a Set SubjectStatus rule action to set the date for thestatus change to an Event Date or date froma date-type Item.


Support for theOptional RequirementMode in the ReviewPlan Editor

Medium By Study Build Study Designer No *Studydesigners mustcreate or edit aReview Planusing theOptionalrequirementmode.

The Review Plan Editor now supports theOptional Requirement Mode for Event Datesand Items.


Rule EditorEnhancements

Low Auto-on Study Designer Yes *Studydesigners cansee and usethese changesupon accessingthe Rule Editor.

Instead of typing in the path for identifiersdirectly in the Rule Editor, users can searchfor identifiers and insert them with #definestatements. As part of this feature, users canalso collapse and expand the Rule Detailspanel.


Select All forAssessments ItemGroup Visibility

Low Auto-on Study Designer Yes *Studydesigners cansee thesechanges rightaway.

Users now have the option to select all Itemsunder an Item Group in addition to the abilityto select Items independently.


Change Log

This feature list is subject to change prior to the release. We will begin tracking changes on: 3/9/2020

Date Description Impact

3/2/2020 Published the initial version of the RIA N/A

3/9/2020 Updated the description for "Automating the Autocoding andSuggestions Job" to provide more detail about the changesassociated with this feature.

The RIA now includes up to date feature descriptions.

3/12/2020 Updated the risk of "Automating the Autocoding and SuggestionsJob" from "High" to "Low"

The RIA now includes up to date feature risk.

3/18/2020 Updated the RIA format by adding new columns to provideinformation about end user impact

The RIA now includes additional information.

3/23/2020 Removed the 'New "Workbench Tab" Permission in RoleManagement ' feature from the RIA, as this feature was removedfrom the VIA.

Updated the risk of "Automating the Autocoding and SuggestionsJob" from Low to High

The RIA now includes an up to date list of features with up to datefeature risk.

4/6/2020 Updated the Training Impact for the New "View Coding" Permissionand Study Designer Role Enhancements features

Updated the Description and Impacts Existing Studies comment forthe New "View Coding" Permission feature

The RIA now includes up to date training impact, feature descriptions,and study impact information.

4/9/2020 Updated the Enablement, Affect on Existing Studies, and Descriptionfor the "Automated Deployments Include Custom Study Roles &Objects" and "Manage Custom Object Permissions in RoleManagement" features

The RIA now includes up to date information about features for releasein 20R1.

Documents

Vault CDMS Release Impact Assessment · forms through Form Linking in the Data Entry and Studio tabs. For example, an Adverse Event form can be linked to one or more Concomitant Medication