Slide 1: 23R1 Customer Webinar: Studio, Admin, Coder
23R1 Customer Webinar Studio, Admin, Coder March 23, 2023
Slide 2: CDMS Product Managers
CDMS Product Managers Dennis Natalie Kathy Eric Haas Moore Kochanski Tibaldi Sr. Product Product Product Product Manager Manager Expert Manager Studio, Library, Mo Admin, Eric EDC Rules Retrospective Al-Adeeb User Mgmt Emerton Amendments Lindsay Chan Principal Sr. Product Product Manager Technical M
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: Studio
V Studio
Slide 8: Rules Archive
Day 1 Impact to Rules Archive Clinical Teams No • Overview − Rule archive provides a method for “soft-deleting” rules - marking them as archived so they are excluded from the design and from rule execution. Rules can be deleted (moved to archived status) and restored when they have been archived. Vi
Slide 9: General Quality of Life Enhancements
Day 1 Impact to General Quality of Life Enhancements Clinical Teams No • Overview − Added a number of minor quality of life enhancements and bug fixes to include: • Fixed difference report returning a change to rule action order as modified • Skipped a number of validations when they applied to obje
Slide 10: SDS Enhancements
Day 1 Impact to SDS Enhancements Clinical Teams No • Overview − Several enhancements that improve overall usability and fill gaps • Updated column headers and order to match UI • Added missing columns and removed unused columns • Updated formatting for improved filtering and searching Visibility • N
Slide 11: Rules
V Rules
Slide 12: @PreviousEvent Schedule Sorting
Day 1 Impact to @PreviousEvent Schedule Sorting Clinical Teams No • Overview − Rules using @PreviousEvent identifiers can now be configured to sort Events in order of the Schedule configuration in Studio − @PreviousEvent rules that are sorted by Schedule can be configured to either Visibility ignore
Slide 13: @PreviousEvent Schedule Sorting
Day 1 Impact to @PreviousEvent Schedule Sorting Clinical Teams No Visibility Study Designers, Librarians Configuration Studio When Sort Dependencies Events By is Schedule, Skip Rules Engine v2 ILB is configurable Available for existing studies Copyright © Veeva Systems 2023 13
Slide 14: Subject Status Date Rollback
Day 1 Impact to Subject Status Date Rollback Clinical Teams No • Overview − Added a study setting to enable rolling back historical Subject Status Dates when the associated Subject Status rule result changes from true to false • When set to No, behavior is the same as pre-23R1 Visibility Study Desig
Slide 15: Admin
V Admin
Slide 16: User Access Report
Day 1 Impact to User Access Report Clinical Teams No • Overview − New report type available in System Tools > Users − Produces a csv file containing a chronological audit log of user access activities from creation of vault to current date − Can be run on select studies or vault-wide in 6 month incr
Slide 17: User Access Report
Day 1 Impact to User Access Report Clinical Teams No Visibility User Admin Super User Custom Roles w/ “View Users” Configuration N/A Dependencies Available on all vaults Copyright © Veeva Systems 2023 17
Slide 18: Disable Manual Casebook Creation
Day 1 Impact to Disable Manual Casebook Creation Clinical Teams No • Overview − New setting in EDC Tools - Study Settings − Default value is “No” - casebook creation is unchanged − “Yes” - the New Casebook button will be disabled in Data Entry for that study • Casebook creation via API still support
Slide 19: Disable Manual Casebook Creation
Day 1 Impact to Disable Manual Casebook Creation Clinical Teams No Visibility Lead Data Managers, Librarians, Study Designers Configuration EDC Tools > Study Settings Dependencies Available on all vaults Copyright © Veeva Systems 2023 19
Slide 20: Role Management UI Enhancements
Day 1 Impact to Role Management UI Enhancements Clinical Teams No • Overview − Usability enhancements to the System Tools - Role Management page − Permission dependencies displayed via tooltip when creating or editing a custom role − Permissions in grid are now grouped into the following sections: V
Slide 21: Role Management UI Enhancements
Day 1 Impact to Role Management UI Enhancements Clinical Teams No Visibility LDM User Admin Super Users Custom role w/ Manage Study Roles Configuration N/A Dependencies Available on all vaults Copyright © Veeva Systems 2023 21
Slide 22: Review Plan Assignment Enhancements
Day 1 Impact to Review Plan Assignment Enhancements Clinical Teams No • Overview − The single Review Plan Assignment tab with subtabs has been moved to two individual tabs: • Review Plan Assignment Criteria • Review Plan Manual Assignment Visibility − Two new permissions have been created to provide
Slide 23: Review Plan Assignment Enhancements
Day 1 Impact to Review Plan Assignment Enhancements Clinical Teams No Visibility LDM Librarians Study Designers Super Users Configuration New permissions available for use with custom roles Dependencies Available on all vaults Copyright © Veeva Systems 2023 23
Slide 24: General Admin Enhancements
Day 1 Impact to General Admin Enhancements Clinical Teams Yes • Overview − ‘Manage Jobs’ permission granted to CDMS Clinical Research Associate & CDMS Data Manager roles to support Listings − Study Access automatically removed when a user is inactivated − Prevent custom role from being removed in ta
Slide 25: Extracts
V Extracts
Slide 26: Study Data Extract New Lab Format
Day 1 Impact to Study Data Extract New Lab Format Clinical Teams No • Overview − In the 23R1 version of the SDE, there will be a new lab format which replaces the existing format for forms configured with Local Labs. Users can still retrieve the previous format in older SDE versions. − This format p
Slide 27: Study Data Extract Definition Names in Datasets
Day 1 Impact to Study Data Extract Definition Names in Datasets Clinical Teams No • Overview − In the 23R1 version of the SDE, Event Group, Event, Form, Item Group and Item definition names have been added to the clinical datasets and various System datasets. − System Datasets impacted: Visibility •
Slide 28: Study Data Extract Enhancements
Day 1 Impact to Study Data Extract Enhancements Clinical Teams No • Overview − In the 23R1 version of the SDE, the following general enhancements were made: • Boolean formatting override: users can choose the output format of booleans • The default format is “Y/N” Visibility • CSV column headers wil
Slide 29: Coder
V Coder
Slide 30: Sync Synonym List
Day 1 Impact to Sync Synonym List Clinical Teams No • Overview Users can designate one Synonym List and Do Not Autocode List to perform all autocoding and suggestions actions for two vaults. Autocoding and Suggestions will be consistent across all Studies Visibility Coder Admin that span the vaults.
Slide 31: Coder Tools New Navigation
Day 1 Impact to Coder Tools New Navigation Clinical Teams No • Overview The main navigation in Coder Tools is now on the left panel. Visibility Coder Admin • Use case This new UI experience is scalable as we add more features to Coder Tools. Configuration N/A Dependencies None Copyright © Veeva Syst
Slide 32: Coder Config Resilience
Day 1 Impact to Coder Config Resilience Clinical Teams No • Overview With this release, Study designers can still see coding configurations for Form and Item Definitions from an deleted or orphaned Verbatim Item Definition or orphaned or deleted a related coding Item Visibility Coder Admin Definition. S
Slide 33: E2BLink (Safety Integrations)
E2BLink (Safety Integrations)
Slide 34: Duration Inclusion Rules for Related Safety Data
Day 1 Impact to Duration Inclusion Rules for Related Safety Data Clinical Teams No • Overview − Before release: only site linked form data included to safety transfer / cases − At release: (via study design) Visibility • Auto include related safety case data (ConMed, Med History, Labs,..) • Disallow
Slide 35: Duration Inclusion Rules for Related Safety Data
Day 1 Impact to Duration Inclusion Rules for Related Safety Data Clinical Teams No Non Study Drug Rules (Con Meds Example) Visibility Safety Admin “Site deems relevant” Study Designers - linked in Data Entry (Paired Safety System) Configuration Captures any ongoing Study by Study - at SAE Start Stud
Slide 36: Duration Inclusion Rules for Related Safety Data
Day 1 Impact to Duration Inclusion Rules for Related Safety Data Clinical Teams No Non Study Drug Rules (Close AEs) Visibility Safety Admin No site linking Study Designers (Paired Safety System) Configuration Study by Study - Other AEs within 2 Study Designers days before the SAE Safety Admin (serio
Slide 37: Duration Inclusion Rules for Related Safety Data
Day 1 Impact to Duration Inclusion Rules for Related Safety Data Clinical Teams No Pre 23R1 behavior - single dispense, closest on/before the SAE Start Visibility Safety Admin Study Designers (Paired Safety Study Drug System) Rules Configuration Or…fine tune, any dispense Study by Study - before, +
Slide 38: New Configurable Study Behaviors
Day 1 Impact to New Configurable Study Behaviors Clinical Teams • Overview No − At release: − Before Configurable release: Certain study level settings (E2BR3) were not configurable (static) • Use cases (values to safety) Visibility − Subject Number format (composite, Country-Site-Subject, or just S
Slide 39: Enhanced Alerting on Important First Submit
Day 1 Impact to Enhanced Alerting on Important First Submit Clinical Teams No • Overview − Before release: • End user could answer ‘Yes’ to all important ‘Serious?’ • But (!!) - not initially submit the form Visibility • The ‘Yes’ was the start of the clock for reporting to agencies • Result? → Dela
Slide 40: Enhanced Alerting on Important First Submit
Day 1 Impact to Enhanced Alerting on Important First Submit Clinical Teams Yes Safety Administrator, Lead DM - Landing Area (New) Visibility DM / CRA Site Users (if turned on) Configuration Study by Study - Configure recipients Study Designers of new alert, plus Safety Admin other alert types (comin
Slide 41: Enhanced Alerting on Important First Submit
Day 1 Impact to Enhanced Alerting on Important First Submit Clinical Teams Configure Yes Recipients Visibility DM / CRA Site Users (if turned on) Configuration Study by Study - Study Designers Safety Admin Country specific alerting (i.e. subjects of that country = Dependencies different alert list)
Slide 42: Enhanced Alerting on Important First Submit
Day 1 Impact to Enhanced Alerting on Important First Submit Clinical Teams Yes Review Alerts Visibility DM / CRA Site Users (if turned on) Configuration Study by Study - Study Designers Safety Admin Dependencies Available for all existing studies Copyright © Veeva Systems 2023 42
Slide 43: Enhanced Alerting on Important First Submit
Day 1 Impact to Enhanced Alerting on Important First Submit Clinical Teams Alert Yes Email Visibility DM / CRA Site Users (if turned on) Configuration Study by Study - Study Designers Safety Admin Dependencies Available for all existing studies Copyright © Veeva Systems 2023 43
Slide 44: APIs
V APIs
Slide 45: 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 Visibility • Event dates - through an integration - can be mistakenly update
Slide 46: 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 47: CDMS API: Data Read Only via API
Day 1 Impact to CDMS API: Data Read Only via API Clinical Teams Form Data No Audit trail indication Visibility DM / CRA Site Users * Configuration Study Designers Limited or automatic Reset Form Function Blank form.. Dependencies …but… Available for all → data maintained (assuming other existing stu
Slide 48: CDMS API: Data Read Only via API
Day 1 Impact to CDMS API: Data Read Only via API Clinical Teams Form Data No Visibility DM / CRA Site Users * For the rare need to actually reset the integrated data… (ONLY available at the Configuration form = blank status + Study Designers 2nd action to perform) Limited or automatic Dependencies A
Slide 49: CDMS API: Data Read Only via API
Day 1 Impact to CDMS API: Data Read Only via API Clinical Teams Event Dates No Visibility DM / CRA Site Users * Configuration Study Designers Limited or automatic Event dates controlled by another system - no editing possible Dependencies Available for all existing studies * Copyright © Veeva System
Slide 50: CDMS API: Combination Form Data API
Day 1 Impact to CDMS API: Combination Form Data API Clinical Teams No • Overview − Before release: • Situational issues in integrations - mixed form usage (some values by Visibility integration, some by site) Integration / • Is the form open or submitted? → additional inspection / API calls Other Ve
Slide 51: CDMS API: Combination Form Data API
Day 1 Impact to CDMS API: Combination Form Data API Clinical Teams No Before Release: Visibility Does form No Integration / API Call #1 API Call #<next> exist? (e.g. Other Vendors (get form / items) (add repeat form) repeating) API Call #<next> (set data on the Yes form) Yes Yes Is form open for Con
Slide 52: CDMS API: Combination Form Data API
Day 1 Impact to CDMS API: Combination Form Data API Clinical Teams No After Release: In CDMS (it figures out what / when needed..) Visibility Does form exist? (e.g. Is form Integration / repeating) open for Other Vendors API Call #1 Do edit? Should (Set data to a form) changes we need submit change
Slide 53: Evolving Customer Success
Evolving Customer Success Veeva
Slide 54: 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 • Gives customers greater access to the Product team Product organization • Significant increase in the investment • Creates more engaged asynchronous
Slide 55: 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 55
Slide 56: 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 57: 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 58: 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 58
Slide 59: Getting Access
• VeevaConnect.com Getting Access • Accessible by Veeva Customers − Work email address, and authentication code • No username and password required Copyright © Veeva Systems 59 2022
Slide 60: Clinical Data Communities
Clinical Data Communities CDB EDC RTSM
Slide 61: Questions
2 Questions
Slide 62: Thank you
V Thank you