Vault CDMS Release Impact Assessment · 8 hours ago · 20R2 Release Impact Assessment The Release Impact Assessment (RIA) documents the new capabilities released in this Vault CDMS

20R2 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 Enablement and Default Impactfor each feature to determine the visibility and configuration requirements. The RIA serves as an early preview of the Validation Impact Assessment (VIA). Once the VIA is available onVeeva Docs, refer to it for more detailed validation information.

This feature list is subject to change prior to the release. We will begin tracking changes on: 6/22/2020

Revision Date: 8/26/2020

VIA Available: 8/3/2020

For detailed feature descriptions, refer to the product release notes, which are available on Vault CDMS Help.

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.

Impact to Sites: If Yes, depending on your vault and study configuration, this feature may impact site users (investigators and clinical researchcoordinators) upon release.

Impact to Sponsors: If Yes, depending on your vault and study configuration, this feature may impact sponsor users (data managers and clinical researchassociates) upon release.

Impact to Coders: If Yes, depending on your vault and study configuration, this feature may impact coding users (clinical coders and coderadministrators) upon release.

https://cdmshelp.veeva.com/lr/rn/general-releases/

Vault CDMS Release Impact Assessment Page 2 of 11

Application Impacted Areas Name Risk Enablement Training Impact Impact to ExistingStudies

Impact toSites

Impact toSponsors

Impact toCoders Description

All Data Entry, DataReview,Assessments, StudyDesign &Configuration, StudyAdministration

Restricted Data High By Study Build*Only instudiescreated afterthe 20R2release

UserAdministrator,Data Manager,ClinicalResearchCoordinator,SubInvestigator,ClinicalResearchAssociate,AssessmentReader,Investigator,Lead DataManager, StudyDesigner,AssessmentEditor

No Study designersmust first configurerestricted Forms forthis feature to affecta study.

No Yes No Study designers can configurecertain Form Definitions asrestricted. During the course ofthe study, these Forms will onlybe visible to unblinded userswith permission to viewrestricted data.

All Data Entry, DataReview, StudyDesign &Configuration

Future Date Querieson Event Dates

Medium By Study Build SubInvestigator,ClinicalResearchAssociate, DataManager,Investigator,Lead DataManager

No A study designermust configure anEvent to use thefuture date check.

No Yes No Study designers can nowchoose to have Vault generatea system query when an EventDate is in the future via theFuture Date property on theEvent Definition.

All Data Entry, DataReview, StudyDesign &Configuration

Out of Range EventDate Queries

Medium By Study Build*In studiescreated afterthe 20R2release

SubInvestigator,ClinicalResearchAssociate, DataManager,Investigator,Lead DataManager

No A study designermust configure aStudy for this feature.

No No No Studio users can configure theEvent Window for an Event sothat Vault will create systemqueries if the Event is outsidethe window.

All Deployments,System Tools

New System ToolsArea &Enhancements toVault-levelDeployments

Medium Auto-on *Invaults whereRole by Studyand AutomaticDeploymentsare enabled

UserAdministrator,DeploymentAdministrator,Lead DataManager

Yes Users withappropriate accesswill see the newSystem Tools areaimmediately.

No Yes No Users can manage vault-levelconfigurations from the newTools > System Tools tab,including custom Study Roles(moved from Tools > RoleManagement), custom objectson the deployment whitelist,custom Change Reasons, andexternal connections.Deployment administrators canalso deploy theseconfigurations from vault tovault within System Tools, or



Impact toSites

Impact toSponsors


as part of a study deploymentpackage. This featureintroduces support for ChangeReasons, Reports, andDashboards to deployments.

All Study Administration Data and DefinitionExport

High Auto-on UserAdministrator

Yes The changes to thisjob applyimmediatelyfollowing the release.

No Yes No This feature renamed theJReview Listing job as Data &Definition Export. The exportoutput now includes theExternal ID and SDTM name,when available, and is moremachine readable. The job canbe configured to includerestricted data if the user hasthe ability to access it.

All System Tools, StudyAdministration,Study Design &Configuration

Template Vaults Medium Support *InStudies usingthe automaticdeploymentmodel

VaultAdministrator,DeploymentAdministrator,Study Designer

No Organizations mustwork with Veeva tocreate a library vault.

No No No Customers can request aseparate vault or set of vaultsto use as a “template”. In thetemplate vault, an organizationcan create and manage a setof standards for study design.Then, study designers cancopy from these standardswhen designing their ownstudies, without having to copyfrom a vault that is a part oftheir standard set ofenvironments (development,UAT, training, and production).

All System Tools Vault DifferenceReport

Medium Auto-on *Invaults whereRole by Studyand AutomaticDeploymentsare enabled

VaultAdministrator,DeploymentAdministrator,Lead DataManager

Yes This report isavailableautomatically.

No Yes No Users with access to SystemTools may compare the vault-level configuration of twovaults, including customobjects, change reasons,custom study roles, reports,dashboards, and usermanaged groups.

Coder Coding Reconstitute CodeRequests Job NowAutocodes AnyUpdates

Medium Auto-on Clinical CoderAdministrator,Study Designer

No Study designersmust first updateCoding Configurationin a way that requiresthe ReconstituteCode Requests jobfor this to apply.

No No Yes When a user runs theReconstitute Coding Job, thesystem will now attempt toAutocode all the CodingRequests that have beencreated or updated as part ofthe job.

Coder Coding Upversioning ImpactReport

Medium Auto-on Clinical CoderAdministrator

Yes This report isavailableautomatically.

No No Yes With this release, we areproviding an UpversioningImpact Report so that usersmay preview the upversioningimpact before committing to it.



Impact toSites

Impact toSponsors


Users can generate an ImpactReport for any Form orSynonym List.

Coder Coding Coder UIEnhancements

Low Auto-on Study Designer Yes These changes areautomatically visibleto Coder users.

No No No In this release, we’ve added alink to the help page so thatStudy Designers can followstep-by-step instructions toconfigure the Copy Indicationfrom Link feature. We havealso added breadcrumbs toimprove user coordination andnavigation.

Coder Coding Group Mode CodingEnhancements

Low Auto-on Clinical Coder Yes Coder users will seethese changesimmediatelyfollowing the release.

No No Yes Coding very large groups cantake the system some time. Tothis end, we display in-progress indicators whereneeded and allow users tocarry on other tasks.

Coder Coding Nudge User toChrome™ Browserin Coder

Low Auto-on Clinical Coder,Clinical CoderAdministrator

Yes Users not usingChrome™ will seethis notification.

No No Yes Users who use a browser otherthan Google Chrome™ willreceive a notificationrecommending that they switchto the Chrome™ browser.

Coder Reports &Dashboards

Lead DataManagers & DataManagers Can ViewCoding Data inReports & Extracts

High Auto-on Lead DataManager, DataManager

Yes Users with theseStudy Roles willautomatically seenew reporting data.

No Yes No Users with the CDMS LeadData Manager, EDC Lead DataManager, CDMS DataManager, and EDC DataManager study roles can nowview Coding data in configuredReports and Dashboards.

Coder, EDC StudyAdministration,Study Design &Configuration

Relaxed StudyUpdate Restrictions

Medium Auto-on DeploymentAdministrator,Lead DataManager, StudyDesigner

No Study designersmust make thesechanges on a newversion for thisfeature to affectexisting studies.

No Yes No We relaxed restrictions onstudy updates after the initialversion. The following changesare now allowed:- Users can edit or deleteDefault Data for Item Groups.- Event Groups, Forms, andItem Groups can be movednon-repeating to repeating.- Events and Forms can bemoved from non-dynamic todynamic.

Coder, EDC Study Design &Configuration

Copying a Formalso Copies CodingConfiguration

Medium Auto-on Study Designer No Study designersmust copy a Form tosee this change.

No Yes No When a study designer copiesa Form, Vault also copies thatform's Coding Configuration.

EDC, Coder Study Design &Configuration

SDS Enhancements Medium Auto-on Study Designer Yes Study designers willsee these

No Yes No SDS enhancements added inthis release include:



Impact toSites

Impact toSponsors


enhancements thenext time theygenerate the SDS.

- New Review Plan tab- New Assessments tab- New columns in Rules tab- Bug fixes for length andoverride labels- Dynamic rules listed inSchedule tab- Item Group layout optionslisted on Form Definitions

Coder, EDC Study Design &Configuration

Study DifferenceReportEnhancements

Medium Auto-on Study Designer Yes Study designers willsee theseenhancements thenext time theycompare casebookversions.

No Yes No Diff Report enhancementsinclude adding a number ofcategories to the reportsummary, including buildnumber and whether or not toinclude or exclude EventGroups and Events, Order,Rules, Views, Study Settings,Coding Configuration, andReview Plans. A UATValidation script has also beenadded for Rules.

DataWorkbench

Workbench Coded Terms inWorkbench

Medium Auto-on *Invaults usingthe VaultCoderapplication

Lead DataManager

Yes Listings for Formsusing Vault Coderwill show these newcolumns after therelease.

No Yes No Vault includes coded terminformation for EDC Formsusing Vault Coder in theWorkbench Export package.

DataWorkbench

Workbench Listing Cell DetailsPanel

Medium Auto-on Lead DataManager

Yes This panel isavailable on all newand existing listings.

No Yes No Users can open the CellDetails panel to view additionalcontext and details about alisting cell, such as its reviewstatus and signature state, aswell as open a query on thatdata item without leaving thelisting context.

DataWorkbench

Workbench Listing CellHighlighting


Yes These highlightsdisplay automaticallyon all listings.

No Yes No Workbench will show a visualindicator for Items and Formsmarked as Intentionally LeftBlank, an Item has a query, orif the Event was marked as DidNot Occur.

DataWorkbench

Workbench View & Edit ListingProperties


Yes Workbench users willbe able to view andedit the properties ofexisting listings afterthe release.

No Yes No Workbench users can view andedit the properties of theirlistings.

DataWorkbench

Workbench View ImportPackages inWorkbench


Yes Workbench usersmay view their importpackage status

No Yes No With this release, users canreview all import packages(both EDC and third party) and



Impact toSites

Impact toSponsors


immediately. their import progress from thenew Import > Packages page

DataWorkbench

Workbench Workbench DataExport


No Workbench usersmust create ExportDefinitions to usethis feature.

No Yes No Workbench users can createExport Definitions, whichrepresent a collection of listingsfor export. Then, they cangenerate and download theseexport packages (ZIP).

DataWorkbench

Workbench EnhancedScheduling for 3rdParty Import

Low Auto-on Lead DataManager

No A Workbench usermust update theirimport manifest fileto use this feature.

No Yes No Workbench users can nowchoose to match on ExternalID, Name, or Event Date whenimporting third party data. Theycan also choose to not matchto any EDC Events and haveWorkbench create new EventDefinitions for each Event inthe import package.

DataWorkbench

Workbench New Functions forCQL

N/A Auto-on Lead DataManager

No A Workbench usermust create or edit aCQL statement touse these newfunctions.

No Yes No Clinical Query Language (CQL)now supports the followingfunctions: Union(), UnionAll(),Pivot(), and UnPivot(). As partof this feature, repeating ItemGroups are now supportedwithin all CQL functions.

DataWorkbench

Workbench Wide & CompactCQL Results

N/A Auto-on Lead DataManager

No Workbench usersmust create or editcustom listings usingthe new CQLkeywords.

No Yes No Users can arrange data itemsin a wide or compact format.Wide format means that everydata item is returned in its owncolumn for every form or itemgroup it was collected in (in thecontext of the CQL statement).Compact format means that adata item’s results arepresented in a single column,regardless of which form oritem group it was collected in.This can be useful forcomparing item values.

EDC Data Entry, DataReview,Assessments, StudyDesign &Configuration, StudyAdministration

Translatable PDFs Medium Auto-on N/A Yes The next PDFexported for a Studywill be translatable.

No No No With this release, all PDFstrings generated by Vault aretranslatable and includetranslation support for CJKcharacters. PDFs included inthis feature include DetailPDFs, Blank PDFs, AnnotatedPDFs, and Clinical AssessmentPDFs.

EDC Data Entry Changed Handling Medium Auto-on *In Sub No This change only Yes No No If a dynamic Form contains



Impact toSites

Impact toSponsors


of Dynamic FormRemoval

studiescreated afterthe 20R2release

Investigator,Investigator,ClinicalResearchCoordinator

applies to studiescreated after the20R2 release.

data, and the controlling Item isedited in such a way that theForm should be removed, Vaultnow shows a banner on theForm indicating that it isn’trequired. Upon reset, Vaultautomatically removes theForm from the Casebook.

EDC Data Entry, DataReview

Updates to SubjectDeletion

High Auto-on *Thisapplies to allexisting andnew studies.

N/A Yes Users will see thesechanges the nexttime they delete asubject.

Yes Yes No When deleting subjects, usersno longer need to reset allevents prior to deletion, asVault automatically deletes alldata alongside the Subject.Users must now also type"DELETE" following reasonselection.

EDC Data Entry, DataReview

EnablementChange: RemovedReview Functionalityfrom Data Entry

Low Auto-on ClinicalResearchAssociate, LeadData Manager,Data Manager

Yes All Studies now havethe Review tabenabled and can nolonger performreview tasks in theData Entry tab.

No Yes No With this release, we enabledthe Review UI for all vaults andremoved all data reviewfunctionality from the DataEntry tab.

EDC Data Entry, DataReview, Reports &Dashboards

Freeze/Lock/SignPropagationUpdates

High Auto-on *Onlyin studiescreated afterthe 20R2release

ClinicalResearchAssociate, DataManager,Investigator,Lead DataManager

Yes Users will see thesestatus propagationchanges the nexttime they freeze,lock, or sign a record.

Yes Yes No This feature completes themigration of the rest of theReview tasks (e.g. Freeze,Lock and Signature) off of theexecution objects (e.g. Item,Item Group, Form, Event,Casebook) and to the ReviewState objects. The signaturestatus of Forms and EventDates will be stored on theSignature State object whichwill eliminate the need topropagate the signature up anddown the execution recordhierarchy. This feature alsointroduced several newstandard report templates.

EDC Data Entry, Reports& Dashboards,StudyAdministration,Study Design &Configuration

Study CloseoutPDFs

High By Study Build*In vaultswhere Role byStudy isenabled

Investigator,Lead DataManager, StudyDesigner,ClinicalResearchCoordinator

No A study designermust create a newSignature Definitionand a lead datamanagers mustinitiate the closeoutprocess from EDCTools.

Yes Yes No Lead data managers cangenerate closeout PDFs forlocked sites, send them to asite for review, and track thereview status. Site users candownload the closeout PDFand either accept or reject it.

EDC Data Entry, SystemTools

Change Reasonsfor Event Reset

Medium Auto-on SubInvestigator,

Yes Users will beprompted to select a

Yes Yes No Data entry users must nowselect a Change Reason when



Impact toSites

Impact toSponsors


Investigator,Lead DataManager,ClinicalResearchCoordinator

reason during eventreset, but anorganization mustconfigure customreasons to use them.

resetting an Event. Anorganization can define customreasons for this action fromSystem Tools > ChangeReasons. As part of thisfeature, when resetting anEvent, the user must type“RESET” in an additionalconfirmation dialog.

EDC Data Review EnhancedSDV/DMR ReviewPlans

Medium By Study Build*In studiescreated afterthe 20R2release

Lead DataManager

No A lead data managermust configureassignment criteria.

No Yes No Source Data Verification will bedriven by Subject Status andcan be applied to a subset ofsubjects. You can providemultiple parameters foridentifying subjects forverification. For a given ReviewTask, Review Plan Assignmentcriteria can be defined by StudyCountry, Study Site, SubjectStatus, or any combination ofthe three. You can also specifya minimum number of subjectsor minimum percentage ofsubjects for assignment.

EDC Data Review Improved ReviewNavigation

Low Auto-on ClinicalResearchAssociate, LeadData Manager,Data Manager

Yes The changes to theReview tab displayautomatically to allusers who canaccess it.

No Yes No In this release, the Review isdivided into two tabs: "Review> My Studies" and "Review >My Study Sites".

EDC Data Review, StudyDesign &Configuration

Data-driven ReviewPlans

Medium By Study Build*In studiesusing version2 of theexpressiongrammar

ClinicalResearchAssociate, DataManager, LeadData Manager,Study Designer

No Study designersmust create a newrule using theOverride ReviewPlan action.

No Yes No Studies can use the newOverride Review Plan ruleaction type to assign a chosenReview Plan to a Form basedon user-entered data.

EDC Study Administration Study RoleEnhancements

High Auto-on *Invaults whereRole by Studyis enabled

UserAdministrator,Lead DataManager

Yes Changes to standardStudy Roles applyautomatically in allvaults where Role byStudy is enabled.

No Yes No Functional enhancements toStudy Roles include thefollowing:

- Manage Review Plan grantsthe ability to execute jobs.

- The Assign Code, DesignStudy, Manage Sites, orManage Review PlanAssignment permissionsautomatically grant access toall Study Sites.

- Standard Study Roles that are



Impact toSites

Impact toSponsors


assigned the Edit Form Linkingpermission are now assignedthe View Form Linkingpermission automatically.

EDC Study Administration Allow for Deletion ofSites

Low Auto-on Lead DataManager

No Lead data managersmust delete a Site forthis change to apply.

No Yes No This feature allows the user todelete sites in EDC Tools inenvironments other thanproduction.

EDC Study Design &Configuration

Date ComparisonConfigurator

High By Study Build Study Designer No Study designersmust create newrules using thisfeature.

No Yes No Study designers can easilycreate Rules that compare twovalues using the newComparison Rules editor,without having to write a ruleexpression.


Cascade Delete forForms

Medium Auto-on Study Designer No Study designersmust delete a Formto see this change.

No Yes No When deleting a Form, studydesigners can choose to deletethe form's related designdefinitions (item groups, items,codelists, and units).


Copy Codelists &Units from AnotherStudy

Medium Auto-on Study Designer No Study designersmust initiate the copyprocess to copy anyrecords.

No Yes No Study designers can copyCodelists and Units from otherstudies they have access to,instead of creating them ineach study.


Casebook Variablesfor Rules

Medium By Study Build Study Designer No Study designersmust edit existingrules or create newones

No Yes No Study designers can referencecertain casebook-levelvariables when writing ruleexpressions.


ReferenceSequence Numberin Rule Expressions

Medium By Study Build*In studiesusing version2 of theexpressiongrammar

Study Designer No Study designersmust edit existingrules or create newones to utilize thisfeature.

No Yes No With this release, studydesigners can reference theSequence Number of arepeating Event Group, Form,or Item Group when writing arule expression. This allowsrules to only evaluate oncertain instances of an EventGroup, Form, or Item Group.


Change Log

This feature list is subject to change prior to the release. We will begin tracking changes on: 6/22/2020

Date Description Impact

6/22/2020 Published the initial version of the RIA. N/A

7/2/2020 Removed the "Disable Vault Create Button on CDMS ApplicationPages" feature and added the "Listing Cell Highlighting" and "View &Edit Listing Properties" features.

The RIA now includes an up to date list of features for 20R2.

7/8/2020 Updated the name and description of the "Library Vaults" feature to"Template Vaults

Updated the enablement notes related to new study availabilitylimitations and data model 2.0 to "Only in studies created after the20R2 release" on the "Restricted Data", "Remove Frozen & LockedStatus Propagation", "Remove Signature Propagation", "CasebookVariables for Rules", and "Comparison Rules". The enablementsettings for these features are unchanged.

Updated the Impacted Application Areas and Descriptions of the"Remove Signature Propagation" and "Remove Frozen & LockedStatus Propagation" features to include that these featuresintroduced new standard report templates.

The RIA now includes up to date feature names, enablement notes, andinformation about impacted application areas.

7/9/2020 Renamed the following features: "Site Review Plan by SubjectPercentage" to "Enhanced SDV/DMR Review Plans", "Review UIEnhancements" to "Improved Review Navigation", "Override theReview Plan for a Form Using Rules" to "Data-driven Review Plans",and "Comparison Rules" to "Date Comparison Configurator"

The RIA now includes up to date feature names.

7/14/2020 Added the "Change Reasons for Event Reset", "Changed Handlingof Dynamic Form Removal", and "Updates to Subject Deletion"features. Renamed the "Event Matching on External ID for 3rd PartyImport" feature as "Enhanced Scheduling for 3rd Party Import" andupdated its description.


7/20/2020 Consolidated the Removed Frozen & Locked Status Propagationand Removed Signature Propagation features into Freeze/Lock/SignPropagation Updates.



7/23/2020 Added the "Coded Terms in Workbench " feature and updated theVIA Availability Date from 7/27 to 8/10.

The RIA now includes an up to date list of features and up to dateavailability dates.

7/24/2020 Updated the VIA Availability Date from "8/10" to "8/3" The RIA now includes the latest date for VIA availability.

7/30/2020 Updated the enablement and impact to existing studies of StudyCloseout PDFs from "Auto-on" to "By Study Build". Updated theenablement of Casebook Variables for Rules and Date ComparisonConfigurator to remove the note that these features are onlyavailable for new studies.

Split the Event Date Query Enhancements feature into two separateitems, Out of Range Event Date Queries and Future Event DateQueries, as the Out of Range Event Date Queries feature is onlyavailable to studies created after 20R2.

The RIA now includes up to date availability and enablement settings for20R2.

8/5/2020 Updated the enablement of "Enhanced SDV/DMR Review Plans"from "Study Feature Flag" to "By Study Build *In studies createdafter the 20R2 release", as well as its impact on existing studies.This feature is not available for studies created after the 20R2release.

The RIA now includes up to date availability and enablement settings for20R2.

8/17/2020 Added the "Listing Cell Details Panel" feature and updated thedescription of the "Coded Terms in Workbench" feature.

The RIA now includes an up to date list of features and descriptions for20R2.

8/21/2020 Updated the Training Impact of "Updates to Subject Deletion" to"N/A", as no standard Study Roles have permission to deletesubjects.

The RIA now includes up to date Training Impact.

8/26/2020 Updated the description for the "Coded Terms in Workbench" featureto clarify the scope of the feature.

The RIA now includes up to date feature descriptions.

Documents

Vault CDMS Release Impact Assessment · 8 hours ago · 20R2 Release Impact Assessment The Release Impact Assessment (RIA) documents the new capabilities released in this Vault CDMS