veeva vault for r&d
TRANSCRIPT
19R1 Pre-release03 APRIL 2019
19R1 CDMSRelease Preview and
Planning April 3, 2019
Please use ‘Q&A’ to ask a
question
3Copyright © Veeva Systems 2019
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
4Copyright © Veeva Systems 2019
Interact With Us!
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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.
7Copyright © Veeva Systems 2019
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%
9Copyright © Veeva Systems 2019
Veeva Vault Release Schedule
JanFeb
Mar
Apr
JunJul
Aug
Oct
Nov
Dec
2019CDMS Product
Release Strategy
MaySep
19R1
19R2
19R3
10Copyright © Veeva Systems 2019
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
18Copyright © Veeva Systems 2019
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
19Copyright © Veeva Systems 2019
Query Enhancements Auto On
All Users
Rule Name available in info pop up
Text limit from 255 to 500
20Copyright © Veeva Systems 2019
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
25Copyright © Veeva Systems 2018
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
26Copyright © Veeva Systems 2018
Access Audit Trail
Inspect Audit Trail for each Code Request
Auto On
Coder Users
27Copyright © Veeva Systems 2018
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
28Copyright © Veeva Systems 2018
Support for Codelist Coding Properties
Support for Codelistbased Coding Properties
Auto On
Coder Users
29Copyright © Veeva Systems 2018
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/
36Copyright © Veeva Systems 2018
Validation Impact Assessment Document• Veeva QMS Document to be provided by your project manager
37Copyright © Veeva Systems 2018
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