Slide 1: 23R1 Customer Webinar For All
23R1 Customer Webinar For All March 23, 2023
Slide 2: CDMS Product Managers
CDMS Product Managers Margaret John Roeckel Wehner (JB) Kathy Tibaldi Sharon Lin Product Manager Director, Product Manager Data Entry, Review Product Product Expert UI, Reports Management Data Entry, Query EDC Handling, Medical Local Labs Assessments Copyright © Veeva Systems 2023 2
Slide 3: Veeva Vault Release Schedule
Veeva Vault Release Schedule 23R3 Jan Dec Feb Nov Mar 2023 Apr Oct CDMS 23R1 Product Sep Release May Aug Jun Jul 23R2 Copyright © Veeva Systems 2023 3
Slide 4: 23R1 Release Calendar
23R1 Release Calendar Sun Mon Tue Wed Thu Fri Sat 20 21 22 23 24 25 23R1 Release Webinar 23R1 Pre-Release Mar 9 AM PT - All Customers 10 AM PT - Studio, Upgrade Admin, Coder 26 27 28 29 30 31 01 Validation Docs 02 03 04 05 06 07 08 APR 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23R1 General Release U
Slide 5: 23R1 Release Dates
23R1 Release Dates Mar 24 Mar 27 Apr 21 Available Pre – Release Validation Docs 23R1 Release Resources • Clone of UAT • Located in VeevaDocs • All Customers Vaults https://cdmshelp.veeva. • Special Request for DEV com/lr/rn/general-releas • Users • Validation Project Plan upgraded to 23R1 • Business
Slide 6: 23R1 Feature Summary
23R1 Feature Summary Sites Study Designer Admin Coding ● Form Submission Updates ● Rules - Sorting @PreviousEvent by ● User Access Report ● Sync Synonym Lists ● Site Closeout Enhancements Schedule ● Disable Manual Casebook ● Coder Tools New Nav ● General Enhancements ● SDS Enhancements Creation ● Co
Slide 7: Sites / CRAs / Data Managers
V Sites / CRAs / Data Managers
Slide 8: Data Entry
V Data Entry
Slide 9: Form Submission Updates
Day 1 Form Submission Updates Impact to Clinical Teams Submit Button Yes • Overview − The Complete button has been relabeled to be the Submit button • Functionally the button is the same • Users will click Submit when they’re done entering data to submit the form Visibility − Messaging around autosa
Slide 10: Form Submission Updates
Day 1 Form Submission Updates Impact to Clinical Teams Submit Button Yes Visibility Sites Configuration N/A Users seeing the Submit button for the first time will be presented with a New Dependencies Feature update, explaining the feature Available for all existing Copyright © Veeva Systems 2023 stu
Slide 11: Form Submission Updates
Day 1 Form Submission Updates Impact to Clinical Teams Submit Button Yes Visibility Sites Configuration N/A Dependencies Available for all existing Copyright © Veeva Systems 2023 studies 11
Slide 12: Form Submission Updates
Day 1 Form Submission Updates Impact to Clinical Teams Form Not Submitted Dialog Yes • Overview − When a user navigates away from an In Progress form, they will see a Form Not Submitted confirmation dialog − The user will have three options: 1. Submit the form Visibility 2. Continue editing the form
Slide 13: Form Submission Updates
Day 1 Form Submission Updates Impact to Clinical Teams Form Not Submitted Dialog Yes Visibility Sites Configuration Support - Automatically enabled but can be disabled on request Dependencies Available for all existing Copyright © Veeva Systems 2023 studies 13
Slide 14: Site Closeout without Restricted Data
Day 1 Impact to Site Closeout without Restricted Data Clinical Teams Yes • Overview − When a site does not have any restricted forms, the Closeout PDFs will no longer be marked as restricted − Lead data managers will no longer need a custom role to generate non-restricted Closeout PDFs Visibility −
Slide 15: Site Closeout without Restricted Data
Day 1 Impact to Site Closeout without Restricted Data Clinical Teams Yes Visibility Sites, Principal Investigator, Lead Data Manager Configuration N/A Only applicable to sites Dependencies without restricted form Only definitions applicable for sites without Copyright © Veeva Systems 2023 restricted
Slide 16: Site Closeout without Restricted Data
Day 1 Impact to Site Closeout without Restricted Data Clinical Teams Yes Visibility Sites, Principal Investigator, Lead Data Manager Configuration N/A Lead DM will no longer be presented with Restricted Data warning when Dependencies generating Closeout PDFs Only applicable for sites without Copyrig
Slide 17: Site Closeout without Restricted Data
Day 1 Impact to Site Closeout without Restricted Data Clinical Teams Yes Visibility Sites, Principal Investigator, Lead Data Manager Configuration N/A If the site does not have restricted data, the site user will be able to download, accept or Dependencies reject the Closeout PDFs Only without restr
Slide 18: Site Closeout - Updated Messaging
Day 1 Impact to Site Closeout - Updated Messaging Clinical Teams Yes Inform users to first download the PDFs before accepting or rejecting the files Visibility Sites, Principal Investigator, Lead Data Inform users if they are Manager missing the required permissions to download, accept or reject the
Slide 19: Lab Forms - ILB Update
Day 1 Impact to Lab Forms - ILB Update Clinical Teams Yes • Overview − On Lab Forms, the form action “Intentionally Left Blank” has been removed − Site users should use the form option “Lab Tests Not Performed” instead • This is a lab specific ILB • The selected reason will still populate in the ILB
Slide 20: CDMS API: Data Read Only via API
Day 1 Impact to CDMS API: Data Read Only via API Clinical Teams • Overview No − Before release: • Study design for IRT / other data → use of read only field(s) • Users can/would mistakenly ‘reset’ forms with integrated data, and re-sends Visibility can be problematic, depending on the other vendor D
Slide 21: CDMS API: Data Read Only via API
Day 1 Impact to CDMS API: Data Read Only via API Clinical Teams No Form Data Before the API Attempt Visibility DM / CRA Site Users * After the API Attempt - in open status, and notification to end user Configuration about field read only Study Designers Limited or automatic Dependencies Available fo
Slide 22: Review
V Review
Slide 23: Query Teams & Multi-Role Security
Day 1 Impact to Query Teams & Multi-Role Security Clinical Teams No • Overview − When a user with multiple roles opens a query, the system will now stamp the selected query team − This team will be reflected in the Query UI and in the query reports Visibility • Use case CRAs, DMs − Improved query UI
Slide 24: Query Teams & Multi-Role Security
Day 1 Impact to Query Teams & Multi-Role Security Clinical Teams No Visibility CRAs, DMs Configuration N/A Dependencies Query Teams & Multi-Role Security Copyright © Veeva Systems 2023 enabled24
Slide 25: Reports
V Reports
Slide 26: Study Progress Listing Updates
Day 1 Impact to Study Progress Listing Updates Clinical Teams No • Overview − Only applicable for priority studies using the Progress Listings in Reports − When the study’s priority expires, the additional scheduled reports that are sending data to Vault Reports will also automatically expire Visibi
Slide 27: Study Progress Listing Updates
Day 1 Impact to Study Progress Listing Updates Clinical Teams No Visibility CRAs, DMs, LDMs Configuration N/A New warning when scheduling an additional “Send to Reports” jobs Dependencies Progress Listings enabled in Reports Copyright © Veeva Systems 2023 27
Slide 28: Study Progress Listing Updates
Day 1 Impact to Study Progress Listing Updates Clinical Teams No Visibility CRAs, DMs, LDMs Configuration N/A The job’s expiration date will equal the study’s priority expiration date Dependencies Progress Listings enabled in Reports Copyright © Veeva Systems 2023 28
Slide 29: Study Progress Listing Updates
Day 1 Impact to Study Progress Listing Updates Clinical Teams No • Overview − New columns added to all progress listings • Applicable to EDC Tools, Review and Reports versions − The SDV and DMR % columns in the following listings will now round to the nearest integer Visibility • Form Progress Listi
Slide 30: Subject Progress Listing Updates
Day 1 Impact to Subject Progress Listing Updates Clinical Teams No • New Columns − SDV Completion Date • Date when all forms where SDV is required was SDV Completed − DMR Completion • Date when all forms where DMR is required was DMR Completed Visibility CRAs, DMs, LDMs Configuration N/A Dependencie
Slide 31: Event Progress Listing Updates
Day 1 Impact to Event Progress Listing Updates Clinical Teams No • New Columns − Event Date Frozen • Is the event date frozen? − Event Date Frozen Date • When the event date was frozen Visibility − Event Date Locked CRAs, DMs, • Is the event date locked? LDMs − Event Date Locked Date • When the even
Slide 32: Form Progress Listing Updates
Day 1 Impact to Form Progress Listing Updates Clinical Teams No • New Columns − Intentionally Left Blank − Intentionally Left Blank Reason Visibility CRAs, DMs, LDMs Configuration N/A Dependencies Available for all existing studies Copyright © Veeva Systems 2023 32
Slide 33: Query Detail Listing Updates
Day 1 Impact to Query Detail Listing Updates Clinical Teams No • New Columns − Form Status − Number of Query Messages Visibility CRAs, DMs, LDMs Configuration N/A Dependencies Available for all existing studies Copyright © Veeva Systems 2023 33
Slide 34: Assessments
V Assessments
Slide 35: Assessment Enhancements
Day 1 Impact to Assessment Enhancements Clinical Teams Yes • Overview − Added the audit trails for assessments and assessment responses to the UI and assessment PDFs − Added the audit trail for the supplemental data to the assessment PDFs Visibility − Improved the audit trail export to include the f
Slide 36: Local Labs
V Local Labs
Slide 37: Lab Modifier Support for Number Data Type
Day 1 Impact to Lab Modifier Support for Number Data Type Clinical Teams No • Overview − In 22R3, we released the Lab Modifier for Unit Data Type, and this release (23R1) we support the number data type • Use case Visibility − Support lab results with numbers that are >, >=, <=, or < (eg. >1) Lab Ma
Slide 38: Lab Translations for Analytes, Units, and Codelists
Day 1 Impact to Lab Translations for Analytes, Units, and Codelists Clinical Teams No • Overview − Support of additional languages for Analytes, Units, and Codelists, in the Lab Visibility Module • Use case Lab Manager, Data Manager, − Studies have Sites throughout the world want to see Analytes/Uni
Slide 39: Evolving Customer Success
Evolving Customer Success Veeva
Slide 40: Customer Success Update
Customer Success Update Customer Success Evolution Product Expert Benefit • We are creating a new role: Product Experts (former CSMs) as part of the Product team • Gives customers greater access to the Product organization • Significant increase in the investment and quality of product-related conte
Slide 41: Partnering for Customer Success
Partnering for Customer Success Understanding Understanding Understanding the the the Product Product Account Customer Customer Expert Partner Customer Success Copyright © Veeva Systems 2023 41
Slide 42: Release Education Changes After 23R1
Release Education Changes After 23R1 Release Notes Video Demos Veeva Connect Investing in content & Video demos of Engaging through communications key features Veeva Connect Starting with 23R2 we will have improved Release Education Material instead of release webinars 🡪 Stay Tuned! Copyright ©…
Slide 43: SDE: New Lab Form Format
SDE: New Lab Form Format CDMS improves the formatting of the Lab Form Extract in 23R1 FEATURE HIGHLIGHTS BENEFITS • Clinical forms configured with • Lab forms are more readable for Local Labs are formatted to viewing clinical data decrease the number of • Rows are now combined into columns standard
Slide 44: Veeva Connect Communities
Veeva Connect Communities Vision: Create an enjoyable and efficient community for life sciences by bringing customers closer together with Veeva through simple and authentic communication Copyright © Veeva Systems 2023 44
Slide 45: Getting Access
• VeevaConnect.com Getting Access • Accessible by Veeva Customers − Work email address, and authentication code • No username and password required Copyright © Veeva Systems 45 2022
Slide 46: Clinical Data Communities
Clinical Data Communities CDB EDC RTSM
Slide 47: Questions
2 Questions
Slide 48: Thank you
V Thank you