Slide 1: 20R2 Customer Webinar
20R2 Customer Webinar Sites/CRAs/DMs/Coder July 23, 2020
Slide 2: Sharon Lin, Cory Etzcorn
Sharon Lin Principal Product Manager, Veeva CDMS Cory Etzcorn Product Manager, Veeva CDMS
Slide 3: CDMS Product Team
CDMS Product Team Dennis Kochanski Mohammed Al-Adeeb Senior Product Manager, Senior Product Manager, Vault CDMS Vault CDMS Quentin Paresys Rakesh Monassery Product Manager, Senior Product Manager, Vault CDMS Vault CDMS Copyright © Veeva Systems 2020 3
Slide 4: 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 5: Interact With Us!
Interact With Us! Copyright © Veeva Systems 2019 5
Slide 6: October 13–14, 2020 Event
October 13–14, 2020 Develop new industry partnerships Share best practices Network with sponsors, CROs, & sites CLINICAL QUALITY & MANUFACTURING REGULATORY SAFETY IT Copyright © Veeva Systems 6 2020
Slide 7: Veeva Vault Release Schedule
Veeva Vault Release Schedule 20R3 Jan Feb Dec Nov Mar 2020 Oct CDMS Product Apr 20R1 Release Sep Strategy May Aug Jun Jul 20R2 Copyright © Veeva Systems 2019 7
Slide 8: 20R2 Release Calendar
20R2 Release Calendar Sun Mon Tue Wed Thu Fri Sat 19 20 21 22 23 24 25 JUL 20R2 Release webinar 9 AM PT - All Customers 10 AM PT - Studio & Admin 26 27 28 29 30 31 1 2 3 4 5 6 7 8 Validation Docs 20R2 Pre - Release 9 10 11 12 13 14 15 AUG 16 17 18 19 20 21 22 20R2 General Release Customer Copyright
Slide 9: Pre-Release Environment
Pre-Release Environment https://login.veevavault.com AUG ● Clone of UAT ○ Special Request for Dev Monday ● Users ○ Contact Veeva Post 3rd Implementation Manager to add users ● Available up to 4 weeks after the 20R2 upgrade Copyright © Veeva Systems 2019 9
Slide 10: Validation Documents
Validation Documents • Validation Project Plan AUG • IOQ Protocols • Business Requirements Monday Documents 3rd • Traceability Matrixes • System Release Memo • Executed OQ Scripts (unexecuted in Word format available upon request) Copyright © Veeva Systems 2019 10
Slide 11: 20R2 Go Live
20R2 Go Live • ALL customer vaults upgraded to 20R2 AUG • EU starts at 2:00pm PT Friday • APAC & US starts at 5:00 PM PT • May take up to 6 hours 21st Copyright © Veeva Systems 2019 11
Slide 12: 20R2 General Release Resources
20R2 General Release Resources • Resources Available • https://cdmshelp.veeva.com/lr/rn/general-releases/20r2/ − Important Dates − Notifications Opt-In − Feature information − Pre- Release Information − Release Information − Release Impact Assessment (RIA) Copyright © Veeva Systems 2020 12
Slide 13: 20R2 Feature Summary
20R2 Feature Summary Sites Study Designer Admin Coding ● Restricted Data ● Delete Subject & Reset ● Cascading Form Deletion ● Dynamic Review Plans ● Upversioning Impact Event ● Form Copy Enhancements by Subject Status or Report ● Study Closeout ● Copy Codelists and Units Percentage ● Group Coding ●
Slide 14: Feature Enablement Detail
Feature Enablement Detail Auto-On Features Configurable Features Visible •Sites •CRAs •Data Managers •Clinical Assessments •Coders Auto-On Configuration Support •Coder Admin •Admins Turned On Day 1 Turned Off Turned Off •Study Designers Automatically Requires Requires •Report Users available Configu
Slide 15: Sites
V Sites
Slide 16: Restricted Data
Restricted Data Configuration • Overview Study designers can configure a study to restrict (hide) Forms. As a user with Restricted Data Access, an icon will display next to any Forms, Events, or Subjects marked as restricted to raise awareness that visibility is restricted dependent on a Role/Permis
Slide 17: Restricted Access
Restricted Access New Studies ONLY - (Data Model v2 in 20R2) NO Restricted Access Permission w/ Restricted Access Permissions Forms mark Restricted cannot be seen Form mark Restricted can be seen and has a shield icon indicating that is was restricted Delete an object (subject/Reset a Cycle/Reset a
Slide 18: Delete Subject & Event Reset Enhancements
Delete Subject & Event Reset Enhancements AUTOMATIC • Overview When resetting an Event, site users must now select a Reason for Change in addition to typing in “RESET” to confirm the Event reset. When deleting a Subject, site users with permission must now type in “DELETE” to confirm the Subject del
Slide 19: Translatable PDFs
Translatable PDFs AUTOMATIC • Overview All PDF generated by Vault are now translatable in the Blank, Detail, Annotated, and Clinical Assessment PDFs. Vault will use the user’s language that was set in their user record to determine the language in which to create the PDF. Note: User entered text wil
Slide 20: Study Closeout
Study Closeout Configuration • Overview Sponsors can make Closeout PDFs available to site users at the end of a study. Site users are notified via email when Closeout PDFs are available and can be reminded on an automated basis to log in and accept the file based on a cadence set by the sponsor. Whe
Slide 21: Study Closeout Process
Study Closeout Process Job Is queued 1 Assign user 2 Define Study 3 Lock Study. 4 Notify Site 5 Site receives permission Closeout Generate that PDFs are Email for Closeout Signature Closeout PDFS. available notification PDFs have been 6 Site downloaded and Downloads accepted by Site. the PDFs 7 Site
Slide 22: Sites Demo
DEMO Sites Demo Copyright © Veeva Systems 2020 22
Slide 23: CRAs / Data Managers
V CRAs / Data Managers
Slide 24: Review UI Navigation Enhancements
Review UI Navigation Enhancements AUTOMATIC • Overview The Review tab now contains “My Studies” and ”My Study Sites” sub-tabs. ”My Studies” introduces a new navigational pattern to the Review UI that behaves similarly to the Data Entry tab. Users select a Study, then work with the selected study’s S
Slide 25: Review Functionality is in the Review Tab
Review Functionality is in the Review Tab AUTOMATIC • Overview All review functions typically performed by CRAs, monitors, and data managers have been removed from the Data Entry tab. Going forward, all review functions must be performed in the Review tab. These functions include: − Source Data Veri
Slide 26: Performance Improvements
Performance Improvements AUTOMATIC • Overview The Freeze & Lock icons have been removed from the Data Entry screen, but actions will still be disabled when Frozen or Locked. Vault will continue to display the current Freeze/Lock status of each Casebook, Event, Event Date, Form, and Item in the Revie
Slide 27: Locking & Freezing Enhancements
Locking & Freezing Enhancements AUTOMATIC • Overview Parent/Child Relationships with Locking and Freezing When you Lock or Freeze at the Parent Level, all the children beneath the Parent inherits that action. With the new enhancement you can unlock or unfreeze just one of the children below the pare
Slide 28: Sites & CRAs / Data Managers Demo
DEMO Sites & CRAs / Data Managers Demo Copyright © Veeva Systems 2020 28
Slide 29: Coding
Coding
Slide 30: Upversioning Impact Report
Upversioning Impact Report Automatic • Overview The Upversioning Impact Report provides a preview of upversioning to a dictionary release before having to commit to that upversioning. You may generate it for any Form or Synonym List. • Business Value This report can inform your decision to upversion
Slide 31: Group Coding Enhancements
Group Coding Enhancements Automatic • Overview Coding very large groups can take the system some time. To this end, we display an in-progress indicator so that you can see that the group is coding. Meanwhile, you can continue to code other groups. If you choose to recode a group while it is still in
Slide 32: Navigation Enhancements
Navigation Enhancements Automatic • Overview All Coder pages now have breadcrumbs to improve navigation and this allows Coders to switch between Coding Forms while on the Verbatims Page. In addition, the homepage now has filters so that Coding Forms can be filtered by Study, Form, and Dictionary Rel
Slide 33: Reconstitute Code Requests Job Enhancement
Reconstitute Code Requests Job Enhancement Automatic • Overview Previously you had to run the Autocoding and Suggestions Job after running the Reconstitute Code Request Job. Now, running the Reconstitute Code Request Job will not only create and update Code Request based on new coding configurations
Slide 34: LDM and DM Can View Coding Data
LDM and DM Can View Coding Data Automatic • Overview Lead Data Manager and Data Manager now have the permissions to read Coding data. They will be able to generate and view coding data in Reports, Dashboards, and any Extracts. • Business Value LDM and DM can now inspect coding progress and decisions
Slide 35: Coding Demo
DEMO Coding Demo Copyright © Veeva Systems 2019 35
Slide 36: Extracts & Listings
V Extracts & Listings
Slide 37: Data and Definition Export Enhancements
Data and Definition Export Enhancements Automatic • Overview This job provides a full data and definition extract and can be used for third-party reporting system integrations, such as JReview. Enhancements include: if users have permissions for restricted data access, then they can configure the ex
Slide 38: Data Listings with Restricted Data
Data Listings with Restricted Data Automatic • Overview Users with restricted data access will see restricted forms in the Data Listings configuration and will be able to include them in the extract. Users without restricted data access will not be able to extract any data from restricted forms thro
Slide 39: Extract and Listings Demo
DEMO Extract and Listings Demo Copyright © Veeva Systems 2019 39
Slide 40: Thank you!
V Thank you!