Slide 1: 21R3 Customer Webinar: Studio, Admin, Coder
21R3 Customer Webinar Studio, Admin, Coder November 4, 2021
Slide 2: CDMS Product Managers
CDMS Product Managers Dennis Mohammed Quentin Margaret Kochanski Al-Adeeb Paresys Wehner Sr. Product Sr. Product Sr. Product Product Manager Manager Manager Manager Studio, Library Coder, Safety Rules Reports Link Rakesh Lindsay Cory Etzcorn Chan Sharon Lin Monassery Product Manager Associate Princi
Slide 3: Veeva Vault Release Schedule
Veeva Vault Release Schedule 21R3 Jan Dec Feb Nov Mar 2021 Apr Oct CDMS 21R1 Product Sep Release May Au Jun g Jul 21R2 Copyright © Veeva Systems 2021 3
Slide 4: 21R3 Release Calendar
21R3 Release Calendar Sun Mon Tue Wed Thu Fri Sat 1 2 3 4 5 6 21R3 Release webinar NOV 21R3 Pre-Release 9 AM PT - All Upgrade Customers 10 AM PT - Studio, Admin, Coder 7 8 9 10 11 12 13 Validation Docs 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 01 02 03 04 DEC 21R3 General Release Upgrade Cu
Slide 5: 21R3 Release Dates
21R3 Release Dates NOV NOV DEC 05 08 03 Available Pre – Release Validation Docs 21R3 Release Resources • Clone of UAT • Located in VeevaDocs • All Customers Vaults https://cdmshelp.veeva. • Special Request for DEV com/lr/rn/general- • Validation Project Plan upgraded to 21R3 • Users releases/21r2/ •
Slide 6: 21R3 Feature Summary
21R3 Feature Summary Sites Study Designer Admin Coding ● Repeating Item Group ● Arms & Cohorts ● Job Governor ● Batch Upversioning Actions ● Progressive Display ● Audit Trail by Site & Enhancements ● Display Assigned Review ● Repeating Item Group Filtering ● MIsc JDrug Plan Enhancements ● Validation
Slide 7: Subject Groups: Arms, Cohorts, and Substudies
Subject Groups: Arms, Cohorts, and Substudies Simplify the management of arms, cohorts, and sub studies in complex trials 21R3: Create subject groupings and make them visible in casebooks, reporting, and exports • Assign study arms, cohorts, and sub studies to subjects via rule logic Use grouping in
Slide 8: New Rule: Compare Values from Previous or Next
New Rule: Compare Values from Previous or Next No trigger or sequence numbers needed. Just define an anchor and specify +1/-1 Create a query if the subject’s weight changes by more than 5 % from the prior visit - Count Veeva has virtually eliminated New - Countif the need for custom functions or fun
Slide 9: Feature Enablement
Feature Enablement Impact to On Day 1 of the Release, will the Study Clinical Team (Sites, CRAs, Data Managers) see it? Clinical Team Options: Yes or No On Day 1 of the Release, which users see it? Visibility Options: Sites, CRAs, Data Managers, Study Designers, Study Admin (Deploy, Safety, User), C
Slide 10: Studio
V Studio
Slide 11: Librarians and Study Designers - Adding Collections/Studies
Day 1 Impact to Librarians and Study Designers - Adding Collections/Studies Clinical Teams No • Overview Librarians and Study Designers can now add Collections and Studies without being a Vault Owner. The user does need to have “All Study” access on the DEV vault. Visibility • Business Value Study D
Slide 12: Arms and Cohorts
Day 1 Impact to Arms and Cohorts Clinical Teams No • Overview Studies can now track Arm, Cohort, and Substudy assignment at the subject level. Studies can be implemented with any combination of the three subject groupings. Designers will write rules to assign them to a subject and the assignments ar
Slide 13: Progressive Display Enhancements
Day 1 Impact to Progressive Display Enhancements Clinical Teams No • Overview Users can now drive progressive display configuration from the driving item and set multiple dependent items in a single screen. Visibility • Business Value Study Designers Speeds study development. Librarians Configuratio
Slide 14: Empty Form Link Indicator
Day 1 Empty Form Link Indicator Impact to Clinical Teams No • Overview Study Designers can enable a new “Warn When Empty” setting when creating or updating Form Links within Studio. When enabled, Form Link tabs with zero links added will be highlighted in Red in Data Entry & Review. Visibility Study
Slide 15: Rules: Set Subject Status to Randomization Date
Day 1 Impact to Rules: Set Subject Status to Randomization Date Clinical Teams No • Overview For studies with Randomization enabled, a rule can be created to set a subject status to Randomization Date Visibility • Business Value Study Designers Automatically control and define what gets associated w
Slide 16: Previous/Next for repeating objects
Day 1 Impact to Previous/Next for repeating objects Clinical Teams No • Overview Study designers can now target the previous or next instance of a repeating object without having to specify sequence numbers. Visibility This is done by using [-1] or [+1] in identifiers like: Study - @Form[-1].ItemGro
Slide 17: New functions
Day 1 Impact to New functions Clinical Teams No • Overview Study designers have access to a wider array of functions: Visibility − Count(array): returns the number of instances of the aggregate identifier, even nulls − NoBlanks(value/array, value/array, ...): returns an array of all arguments withou
Slide 18: Identifier changes
Day 1 Impact to Identifier changes Clinical Teams No • Overview Study designers have more options in identifiers: Visibility − Aggregates are now available for booleans and time items Study − Some existing attributes are now supported on fully qualified identifiers Designers • Intentionally_left_bla
Slide 19: Admin
V Admin
Slide 20: Deployment - Validation Environments
Day 1 Deployment - Validation Environments Impact to Clinical Teams No • Overview This release introduced a new environment type, Validation. Any existing Studies using the automatic deployment model are eligible to use this environment type. A Study can have up to TWO validation environments. Deplo
Slide 21: Deployment - Migration Environments
Day 1 Deployment - Migration Environments Impact to Clinical Teams No • Overview This release introduced a new environment type, Migration. Any existing Studies using the automatic deployment model are eligible to use this environment type on vaults where “Enable Data Migration” feature flag is enab
Slide 22: Veeva Learning Integration Enhancements
Day 1 Veeva Learning Integration Enhancements Impact to Clinical Teams No • Overview • User administrators can now assign training to users with Access to All Studies (vault-wide userse) and users with Access to All Study Environments (study-wide users). Visibility • When updating the Curriculum to
Slide 23: Veeva Learning Integration Enhancements
Day 1 Veeva Learning Integration Enhancements Impact to Clinical Teams No • Overview • We updated the Training Report to include additional columns. − Courses Assigned Visibility • The additional columns will be displayed after enabling the feature in Biz Admin via Vault Owner Lead Data (lms.coursed
Slide 24: Study Role Enhancements - EDC
Day 1 Study Role Enhancements - EDC Impact to Clinical Teams No • Overview With this release, we made the following functional enhancements to standard Study Roles and their permissions: Visibility − The CDMS Clinical Research Associate role now has the View Casebook permission (Defect fix only Lead
Slide 25: Study Role Enhancements - CDB
Day 1 Study Role Enhancements - CDB Impact to Clinical Teams No • Overview With this release, we made the following functional enhancements to standard Study Roles and their permissions: Visibility − In support of future enhancements, we added the Browse View permission and assigned it to the Lead D
Slide 26: Study Role Enhancements - Randomization
Day 1 Study Role Enhancements - Randomization Impact to Clinical Teams No • Overview With this release, we made the following functional enhancements to standard Study Roles and their permissions: Visibility − All standard and user defined roles that have the Manage Randomization List now need acces
Slide 27: Audit Trail Export Filtering & Performance Improvements
Day 1 Audit Trail Export Filtering & Performance Improvements Impact to Clinical Teams No • Overview When running Audit Trail Export jobs, filters can be applied to only include audit entries during a certain time period and/or activity of certain users. Visibility − Date Range: A start date, end da
Slide 28: Audit Trail Export By Site
Day 1 Audit Trail Export By Site Impact to Clinical Teams No • Overview A new “Audit Trail Export By Site” job has been added to the list of available job types in EDC Tools. Lead Data Managers can now easily export audit trails for up to 10 sites in a single job. Visibility • Business Value Lead Da
Slide 29: Extract Job Governor
Day 1 Extract Job Governor Impact to Clinical Teams • Overview No Production Studies can be marked as “priority” by users with the “Manage study priority” permission (LDM by default). Extract jobs for these studies will run in a priority queue. Priority lasts for 7 days and can be re-applied when it
Slide 30: CDMS APIs
Day 1 CDMS APIs Impact to Clinical Teams No • New CDMS API Enhancements in 21R3 − Updated Retrieve Queries API − Jobs API Visibility • Supports the SDE, Data and Definition Export, Core Listings, Form Progress Listing, Query Detail API Users Listing, Subject Progress Listing, Event Progress Listing
Slide 31: Reports/Extracts
V Reports/Extracts
Slide 32: Study Data Extracts Enhancements
Day 1 Study Data Extracts Enhancements Impact to Clinical Teams • Overview No Enhancements to the SDE including: − SDE Versioning • Users can select which version of the SDE they want to run • Each version will have new features and enhancements Visibility • Versions are named based on the release (
Slide 33: Study Data Extracts Enhancements
Day 1 Study Data Extracts Enhancements Impact to Clinical Teams • New columns added to datasets in the 21R3 version No Dataset Column Change Clinical Datasets SITENUM, EVENTEID - Changed column name from SITE and EVENTID Visibility SYS_FORM EGROUP, EVENTEID, FORMEID, SDVREQ, SDVLAST, - Added Event G
Slide 34: Study Data Extracts Enhancements
Day 1 Study Data Extracts Enhancements Impact to Clinical Teams • SDE Versioning Dropdown No Visibility Lead Data Managers Configuration N/A Dependencies N/A Copyright © Veeva Systems 2021 34
Slide 35: Study Listings
Day 1 Study Listings Impact to Clinical Teams • Overview No − Four new study listings are available from EDC Tools: 1. Form Progress Listing 2. Query Detail Listing Visibility 3. Subject Progress Listing 4. Event Progress Listing Lead Data − Requires access to EDC Tools, Manage Jobs and all sites Ma
Slide 36: Study Listings
Day 1 Study Listings Impact to Clinical Teams No Visibility Lead Data Managers Configuration N/A Dependencies N/A Copyright © Veeva Systems 2021 36
Slide 37: Study Listings
Day 1 Study Listings Impact to Clinical Teams No Visibility Lead Data Managers Configuration N/A Dependencies N/A Copyright © Veeva Systems 2021 37
Slide 38: Coder
V Coder
Slide 39: Batch Upversioning Enhancements
Day 1 Impact to Batch Upversioning Enhancements Clinical Teams No • Overview The Batch Upversioning experience is more intuitive in the ability to determine if you want just Forms or both Forms and Synonym Lists to Upversion, it displays a dialog to confirm Upversioning before running the job, and f
Slide 40: JDrug Upversioning & Suggestions
Day 1 Impact to JDrug Upversioning & Suggestions Clinical Teams No • Overview With JDrug, Coder Admins are able to Upversion, view an Impact Report, use the Code All Forms and Synonym Lists feature (AKA Propagate Code), and import/export a JDrug Synonym List. While the system was able to generate au
Slide 41: Safety Link
V Safety Link
Slide 42: Long Narratives
Day 1 Impact to Long Narratives Clinical Teams No • Overview CRCs can transfer up to 100,000 characters for the Case Narrative field and up to 20,000 characters for the Reporter’s Comments field on the SAE form. Vault then includes the entirety of these field values in the XML file for transfer to t
Slide 43: External Unscheduled Lab Forms
Day 1 Impact to External Unscheduled Lab Forms Clinical Teams No • Overview Safety Admins can map an external unscheduled lab Form Definition in Safety Configurations. If sites link an external unscheduled lab Form Instance to an SAE (using Form Linking), then Safety Link will generate a follow- up
Slide 44: Study Drug Treatment Forms
Day 1 Impact to Study Drug Treatment Forms Clinical Teams No • Overview Safety admins can map Study Drug Treatment Forms in Safety Configurations. When Safety Link generates a First Send or a Follow Up, it will include the one Treatment Form instance that was administered most recently prior to the
Slide 45: Coding Values in E2B XML
Day 1 Impact to Coding Values in E2B XML Clinical Teams No • Overview With this release, Vault automatically includes the coding values assigned in Vault Coder to an SAE in the E2B transfer to the safety system. If the coding values are later changed, Vault generates a follow up message to the safet
Slide 46: CDMS User Community
CDMS User Community ● Support community of trained Studio users ○ Customers and Veeva consultants ● Peer-to-peer communication ○ Discuss and share ideas ○ Q&A ○ Rule syntax, tips ○ Announcements ○ Useful links, webinar recordings ○ Voting ○ Replies from User Community network ● Monitored daily by Ve
Slide 47: Dedicated Demo
For a dedicated demo of any Dedicated these features, DEMO please contact your Account Executive OR Customer Success Manager Copyright © Veeva Systems 2021 47
Slide 48: Thank you
V Thank you