19R1 Pre-release03 APRIL 2019

19R1 CDMSRelease Preview and

Planning April 3, 2019

Please use ‘Q&A’ to ask a

question

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Foreword

• The content of this presentation is subject to change prior to the 19R1 Release

Please note the revision date on the title slide

• Veeva encourages you to always reference Release documentation from our Release pages to ensure you are using the latest information

Help → Release Notes → About the 19R1 Release

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Interact With Us!

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Vault CDMS 19R1 Presenter

David GemzikProduct ManagerDavid.gemzik@veeva.com

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Important Disclosures

The following is intended to outline Veeva’s general product direction. It is intended

for informational purposes only and does not form part of any contract. It is not a

commitment to deliver any specific functionality and it should not be relied upon in

making purchasing decisions. Features and functions described in this document

will be released commercially only when and if they become available. The

development, release, and timing of the features or functionality of Veeva’s

products remains at the sole discretion of Veeva.

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CoderClinical Coding

EDCData Capture & Monitoring

Data WorkbenchCleaning, Reporting, Export

Reinventing Clinical Data ManagementOne product for coding, EDC, data cleaning, and data management

8Copyright © Veeva Systems 2019

Product Investment

50% Customer driven

• 50% reserved development capacity

• Customer success focus

• 6-12 month horizon

50% Veeva Innovation

• Strategic direction

• Leading the industry

• 12-24 month horizon

50% 50%

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Veeva Vault Release Schedule

JanFeb

Mar

Apr

JunJul

Aug

Oct

Nov

Dec

2019CDMS Product

Release Strategy

MaySep

19R1

19R2

19R3

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Key Dates

Task Date

19R1 Regression Testing 3/6/19 - 3/22/19

19R1 Validation prerelease begins Monday 3/18/19 - 3/29/19

19R1 Customer prerelease Vaults Monday 4/1/19 - 4/19/19

Stabilization Sprint and final build 4/9/19

19R1 Production Friday 4/19/19

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Casebooks to Data Entry

“Casebooks” button label is now “Data Entry”

Auto On

All Users

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Improving the Monitoring Experience

Rapid Review and Navigation

Filter for open tasks

Auto On

All Reviewer Users

No More Page Turns UX

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eSignature – Clear SignaturesAuto On

eSig Users

Signature can be cleared by Signer

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eSignature – Sign UX

Sign Form Button added for UX improvement

Auto On

eSig Users

Sign Casebook Button – Sign multiple Events

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Freeze and Lock Event Dates Feature Flag

ReviewersFreeze or Lock the Event Date

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Intentionally Left BlankMarking Form ILB sets all Items ILB

Marking Form ILB removes completed DMR or SDV

Auto On

Data Entry Users

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Data Entry UI

Schedule Sort is now Radio Button as opposed

to picklist

New Event button is Gray color as opposed to Blue

Added “No records to display” message when

no repeating Item Groups present

Auto On

Data Entry Users

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Data Review Dashboards

Monitoring Dashboard

• Site and monitor performance metrics

Data Management Dashboard

• Data cleaning progression metrics

Study Design Dashboard

• Evaluating study design quality and areas of issue

Auto On

All Users

In this release, this feature is Auto On and no longer is enabled through configuration

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Query Enhancements Auto On

All Users

Rule Name available in info pop up

Text limit from 255 to 500

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Audit Trail Export

EDC Tools job to export audit trail

Auto On

All Users

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Enhanced Role Access Model Feature Flag

All Users

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Application Role by Study Feature Flag

All Users

New Application Roles (one per Study)

New Security Profile Permission Sets

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Application Role Functions – per Study

Complete list available in CDMS Documentationhttps://cdmshelp.veeva.com/lr/user-administration/cdms-application-roles/

Feature Flag

All Users

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Coder: UI Enhancements

Popout Coding Panel

User preferences for Filters and Columns are remembered

Smoother resizing of Coding Panel

Auto On

Coder Users

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Grouping Code RequestsToggle switches between Group and List Modes

In Group Mode, identical Code Requests are displayed as one line item

Auto On

Coder Users

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Access Audit Trail

Inspect Audit Trail for each Code Request

Auto On

Coder Users

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Query and Notes Enhancements

Expand Query & Notes Text FieldClose Query

without Entering Text

Updates in real-time with Query and Notes updates from Coder

Auto On

Coder Users

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Support for Codelist Coding Properties

Support for Codelistbased Coding Properties

Auto On

Coder Users

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Autocode from Dictionary

Set to Yes will Autocode from Dictionary after the Synonym List (Default is No)

Auto On

Coder Admin

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Import & Export Syn & Stop Lists

Import & Export Synonym Lists

Auto On

Coder Admin

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Service AnnouncementsAuto On

All Users

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CTMS Integration

• CTMS users of the Vault CTMS & Vault EDC integration open a Casebook from their CTMS vault, the Casebook now opens the in the Review tab of Vault EDC.

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Auto Enablement

Veeva Vault Help lists the Features and their Auto

Enablement

• https://cdmshelp.veeva.com/lr/rn/general-release/19r1/enablement/

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Validation Impact Assessment Document• Veeva QMS Document to be provided by your project manager

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Pre Release Vault login – April 1st

• Use the same URL to login to your prerelease vault : https://login.veevavault.com

• Your username directs you to the pre-release vault.

Questions