Slide 1: 19R1 Pre-release
19R1 Pre-release 03 APRIL 2019
Slide 2: 19R1 CDMS Release Preview and Planning
19R1 CDMS Release Preview and Planning April 3, 2019 Please use ‘Q&A’ to ask a question
Slide 3: Foreword
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 → Ab
Slide 4: Interact With Us!
Interact With Us! Copyright © Veeva Systems 2019 4
Slide 5: Vault CDMS 19R1 Presenter
Vault CDMS 19R1 Presenter David Gemzik Product Manager David.gemzik@veeva.com Copyright © Veeva Systems 2019 5
Slide 6: Important Disclosures
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 deci
Slide 7: Reinventing Clinical Data Management
Reinventing Clinical Data Management One product for coding, EDC, data cleaning, and data management Coder EDC Data Workbench Clinical Coding Data Capture & Monitoring Cleaning, Reporting, Export Copyright © Veeva Systems 2019 7
Slide 8: Product Investment
Product Investment 50% Customer driven • 50% reserved development capacity • Customer success focus • 6-12 month horizon 50% 50% 50% Veeva Innovation • Strategic direction • Leading the industry • 12-24 month horizon Copyright © Veeva Systems 2019 8
Slide 9: Veeva Vault Release Schedule
Veeva Vault Release Schedule 19R3 Jan Feb Dec Nov Mar 2019 Oct CDMS Product Apr 19R1 Release Strategy Sep May Aug Jun Jul 19R2 Copyright © Veeva Systems 2019 9
Slide 10: Key Dates
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 Copyright © Veeva Systems 2019 10
Slide 11: Casebooks to Data Entry
Auto On Casebooks to Data Entry All Users “Casebooks” button label is now “Data Entry” Copyright © Veeva Systems 2019 11
Slide 12: Improving the Monitoring Experience
Improving the Monitoring Experience Auto On All Reviewer Users Filter for open tasks Rapid Review and Navigation No More Page Turns UX Copyright © Veeva Systems 2019 12
Slide 13: eSignature – Clear Signatures
Auto On eSignature – Clear Signatures eSig Users Signature can be cleared by Signer Copyright © Veeva Systems 2019 13
Slide 14: eSignature – Sign UX
Auto On eSignature – Sign UX eSig Users Sign Form Button added for UX improvement Sign Casebook Button – Sign multiple Events Copyright © Veeva Systems 2019 14
Slide 15: Freeze and Lock Event Dates
Freeze and Lock Event Dates Feature Flag Reviewers Freeze or Lock the Event Date Copyright © Veeva Systems 2019 15
Slide 16: Intentionally Left Blank
Intentionally Left Blank Auto On Data Entry Users Marking Form ILB sets all Items ILB Marking Form ILB removes completed DMR or SDV Copyright © Veeva Systems 2019 16
Slide 17: Data Entry UI
Data Entry UI Auto On Data Entry Users New Event button is Gray color as opposed to Blue Schedule Sort is now Radio Button as opposed to picklist Added “No records to display” message when no repeating Item Groups present Copyright © Veeva Systems 2019 17
Slide 18: Data Review Dashboards
Data Review Dashboards Auto On All Users 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 In this release, this feature is Auto On and no longer is ena
Slide 19: Query Enhancements
Query Enhancements Auto On All Users Rule Name available in info pop up Text limit from 255 to 500 Copyright © Veeva Systems 2019 19
Slide 20: Audit Trail Export
Audit Trail Export Auto On All Users EDC Tools job to export audit trail Copyright © Veeva Systems 2019 20
Slide 21: Enhanced Role Access Model
Enhanced Role Access Model Feature Flag All Users Copyright © Veeva Systems 2019 21
Slide 22: Application Role by Study
Feature Flag Application Role by Study All Users New Application Roles (one per Study) New Security Profile Permission Sets Copyright © Veeva Systems 2019 22
Slide 23: Application Role Functions – per Study
Feature Flag Application Role Functions – per Study All Users Complete list available in CDMS Documentation https://cdmshelp.veeva.com/lr/user-administration/cdms-application-roles/ Copyright © Veeva Systems 2019 23
Slide 24: Coder: UI Enhancements
Auto On Coder: UI Enhancements Coder Users Smoother resizing of Coding Panel Popout Coding Panel User preferences for Filters and Columns are remembered Copyright © Veeva Systems 2018 24
Slide 25: Grouping Code Requests
Auto On Grouping Code Requests Coder Users Toggle switches between Group and List Modes In Group Mode, identical Code Requests are displayed as one line item Copyright © Veeva Systems 2018 25
Slide 26: Access Audit Trail
Auto On Access Audit Trail Coder Users Inspect Audit Trail for each Code Request Copyright © Veeva Systems 2018 26
Slide 27: Query and Notes Enhancements
Auto On Query and Notes Enhancements Coder Users Updates in real-time with Query and Notes updates from Coder Expand Query & Notes Text Close Query Field without Entering Text Copyright © Veeva Systems 2018 27
Slide 28: Support for Codelist Coding Properties
Auto On Support for Codelist Coding Properties Coder Users Support for Codelist based Coding Properties Copyright © Veeva Systems 2018 28
Slide 29: Autocode from Dictionary
Auto On Autocode from Dictionary Coder Admin Set to Yes will Autocode from Dictionary after the Synonym List (Default is No) Copyright © Veeva Systems 2018 29
Slide 30: Import & Export Syn & Stop Lists
Auto On Import & Export Syn & Stop Lists Coder Admin Import & Export Synonym Lists Copyright © Veeva Systems 2018 32
Slide 31: Service Announcements
Auto On Service Announcements All Users Copyright © Veeva Systems 2018 33
Slide 32: CTMS Integration
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. Copyright © Veeva Systems 2018 34
Slide 33: Auto Enablement
Auto Enablement • https://cdmshelp.veeva.com/lr/rn/general-release/19r1/enablement/ Veeva Vault Help lists the Features and their Auto Enablement Copyright © Veeva Systems 2018 35
Slide 34: Validation Impact Assessment Document
Validation Impact Assessment Document • Veeva QMS Document to be provided by your project manager Copyright © Veeva Systems 2018 36
Slide 35: Pre Release Vault login – April 1st
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. Copyright © Veeva Systems 2018 37
Slide 36: Questions
2 Questions