Slide 1: 22R1 Customer Webinar: Studio, Admin, Coder
22R1 Customer Webinar Studio, Admin, Coder March 24, 2022
Slide 2: CDMS Product Managers
CDMS Product Managers Dennis Mohammed Quentin Kochanski Al-Adeeb Paresys Sr. Product Sr. Product Sr. Product Manager Manager Manager Studio, Library Coder, Safety Rules Link Lindsay Sharon Lin Eric Haas Chan Principal Product Associate Product Manager Technical Manager Product Tools, User Local Labs
Slide 3: Veeva Vault Release Schedule
Veeva Vault Release Schedule 22R3 Jan Dec Feb Nov Mar 2022 Apr Oct CDMS 22R1 Product Sep Release May Aug Jun Jul 22R2 Copyright © Veeva Systems 2022 3
Slide 4: 22R1 Release Calendar
22R1 Release Calendar Sun Mon Tue Wed Thu Fri Sat 21 22 23 24 25 26 22R1 Release webinar 22R1 Pre-Release MAR 9 AM PT - All Customers 10 AM PT - Studio, Upgrade Admin, Coder 27 28 29 30 31 01 02 Validation Docs APR 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 22R1 General Release U
Slide 5: 22R1 Release Dates
22R1 Release Dates MAR MAR APR 25 28 22 Available Pre – Release Validation Docs 22R1 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 22R1 • Business
Slide 6: 22R1 Feature Summary
22R1 Feature Summary Sites Study Designer Admin Coding ● Item to Form Linking ● Library Classifications ● Study Environment ● Inactivate Coding Forms ● Form Linking UI ● Event Window Enhancements Deletion ● Reconstitute Code Request Job Improvements ● Item to Form linking config ● Vault Config Repor
Slide 7: Library Classification
Library Classification Improve the adoption of library templates by making it easy to find them Copyright © Veeva Systems 2022 7
Slide 8: Safety Codelist Mapper
Safety Codelist Mapper Easily Support E2B Codelist Codes Patient Gender Example: ❑ M ❑ M ❑ 1 ❑ 1 ❑ F ❑ F ❑ 2 ❑ 2 Vault EDC Mapper Safety System Vault CDMS now transfers the mapped code values to the safety system. Copyright © Veeva Systems 2022 8
Slide 9: Goal Achieved: Death to Custom Functions!
Goal Achieved: Death to Custom Functions! Necessary functionality should exist within the product itself • Veeva has been working diligently to natively support all common scenarios where customers typically relied on custom functions. • As of 22R2, customers should no longer need Custom Triggers to
Slide 10: Goal Achieved: Death to Custom Functions!
Goal Achieved: Death to Custom Functions! Common Questions • What about existing studies? No change or action is needed. We will leave existing Custom Trigger capabilities in place. • What’s Next? Meet with your CSM to discuss how existing triggers will be replaced by productized functionality in yo
Slide 11: Studio
V Studio
Slide 12: Item Form Linking (Studio Config)
Day 1 Impact to Item Form Linking (Studio Config) Clinical Teams No • Overview − Added a new item type called “Form Link” − Study Designers can define what display items are shown in EDC − Only available in Data Model 2 studies Visibility Study • Use case designers, Librarians − Supports the EDC fea
Slide 13: Item Form Linking (Rules)
Day 1 Impact to Item Form Linking (Rules) Clinical Teams No • Overview Rules support accessing data from a form linked through an item, similar to what is already available for form to form links. Visibility Study The identifier uses the same / concept to access the linked form. designers, Librarian
Slide 14: Item Form Linking
Day 1 Impact to Item Form Linking Clinical Teams No Visibility Study Designers, Librarians Configuration Studio Dependencies Data Model 2 Copyright © Veeva Systems 2022 14
Slide 15: Event Window Enhancements
Day 1 Impact to Event Window Enhancements Clinical Teams No • Overview − Added Event Group to the Event Offset selection − Added “Previous” Event as a selection - this drives the planned date from the last date in the schedule Visibility − Allow users to now override the 1st Event in a repeating Eve
Slide 16: Library Classifications
Day 1 Impact to Library Classifications Clinical Teams No • Overview − Introduces a set of Classification Types and values to be applied to Form definitions − Classification values are managed by the Librarian − Study designers will be able to search by classification when copying forms from the Vis
Slide 17: General Library Enhancements
Day 1 Impact to General Library Enhancements Clinical Teams No • Overview Added two minor enhancements to the library functionality: Visibility − Libraries will now “adopt” an object copied into the library from another study Study • The Origin Key (viewable in the Library Report) will now reflect t
Slide 18: General Studio Enhancements
Day 1 Impact to General Studio Enhancements Clinical Teams No • Overview − Removed System Rules from the User Defined Rules list • Use case Visibility Study − System rules couldn’t be maintained directly by users, this reduces the amount of designers, noise visible through the User Defined Rules lis
Slide 19: Comparison rules enhancement
Day 1 Impact to Comparison rules enhancement Clinical Teams No • Overview The Comparison Rules grid now has an “Override Query Message” column that allows the definition of a query message to be used instead of the default message. Visibility Study The Comparison rules tab also shows the number of c
Slide 20: Standardize dates in email notifications
Day 1 Impact to Standardize dates in email notifications Clinical Teams Yes • Overview Date and datetime items included in email rules are standardized using the date format and twelve-hour time parameters defined in Studio. Datetimes are also displayed in the Site’s Visibility timezone. All This fe
Slide 21: Query scoping for repeating objects
Day 1 Impact to Query scoping for repeating objects Clinical Teams No • Overview Studies created after 22R1 will benefit from enhanced query scoping for repeating objects. Existing studies can turn it on through business admin. Visibility Vault When the same identifier is used multiple times in an e
Slide 22: New attributes and functions for rules
Day 1 Impact to New attributes and functions for rules Clinical Teams No • Overview New attributes: Visibility − On item: unit__v, translated_unit__v, change_reason__v Study − On @Casebook: subject_name__v designers, Librarians Functions: − Median(): returns the median value of an aggregate or multi
Slide 23: Updated form requirements in rule editor
Day 1 Impact to Updated form requirements in rule editor Clinical Teams No • Overview The Form dropdown in the Rule Details panel is now only required if: Visibility − The expression or action contains an @Form identifier Study − The action is Set item value, Send email, Disable, Override review pla
Slide 24: Admin
V Admin
Slide 25: Study Environment Deletion
Day 1 Impact to Study Environment Deletion Clinical Teams • Overview No • The Delete action in the Actions menu for Study Environments has been renamed to Delete Environment. Users can use this action to delete a Study Environment. Users must enter the Study Name to complete deletion. • In addition,
Slide 26: Vault Configuration Report
Day 1 Impact to Vault Configuration Report Clinical Teams No • Overview With Vault Configuration Reports, you can generate a Microsoft Excel report containing configuration information, including Vault Settings, Study Configuration, Roles, Change Reason Configuration, Security Policies, Report Types, Re
Slide 27: Study Role Enhancements
Day 1 Impact to Study Role Enhancements Clinical Teams No ● In support of the Library Classification feature, we added the following permissions: ○ View Classification - CDMS Study Designer, CDMS Study Designer Read Only, CDMS Librarian, CDMS Super User Visibility ○ Edit Classification - CDMS Librarian
Slide 28: CDMS APIs
Day 1 Impact to CDMS APIs Clinical Teams No ● Overview: ○ Pagination Framework ■ Enabled on Retrieve Users, Retrieve Subjects, Retrieve Queries ○ Create User API - supports the new Vault User Import framework. Not backward compatible. ○ Open Coding Query API Visibility ○ Retrieve Queries CDMS API ■
Slide 29: External FTPS
Day 1 Impact to External FTPS Clinical Teams No ● Overview: ○ EDC now supports outbound connections between EDC and External FTPS servers to send export files such as the Study Data Extract and Code Request Export. There is an enhanced UI in the EDC Tools FTPs tab and a connection type for CDB Workb
Slide 30: Reports/Extracts
V Reports/Extracts
Slide 31: SDE Enhancements
Day 1 Impact to SDE Enhancements Clinical Teams No ● The SDE includes the following features in 22R1: ○ Option to include randomization treatment in the SDE (for users with Randomization enabled) ■ Users must either have their study unmasked, or if the study is masked, the user running the job Visib
Slide 32: SDE Enhancements
Day 1 Impact to SDE Enhancements Clinical Teams No Visibility Lead Data Manager Configuration N/A Dependencies N/A Copyright © Veeva Systems 2022 32
Slide 33: SDE Enhancements
Day 1 Impact to SDE Enhancements Clinical Teams No ● General Enhancements: ○ In the SDE versions 22R1 and later, datetime items in the Site’s timezone will now use the SAS format DATETIME22.3. Visibility ○ The SDE zip file will be compressed for SAS in versions 22R1 and later, and any version prior
Slide 34: Reconstitute Code Request Job Enhancements
Day 1 Impact to Reconstitute Code Request Job Enhancements Clinical Teams ● Overview No This enhancement allows users to run the Reconstitute Code Requests job on all forms and select coding forms. ● Use case Visibility This feature improves performance of the job and allows users more flexibility ar
Slide 35: Unique Terms Report
Day 1 Impact to Unique Terms Report Clinical Teams No • Overview In Coder Tools, there is a new section for Jobs, where Coder Admins can run the Unique Terms Report. This report will include unique coding records from across multiple studies. Users will select a From Visibility Date, and new data co
Slide 36: Unique Terms Report
Day 1 Impact to Unique Terms Report Clinical Teams No Visibility Coder Admin Configuration N/A Dependencies Coding Copyright © Veeva Systems 2022 36
Slide 37: Unique Terms Report
Day 1 Impact to Unique Terms Report Clinical Teams No Visibility Coder Admin Configuration N/A Dependencies Coding Copyright © Veeva Systems 2022 37
Slide 38: Coder
V Coder
Slide 39: Inactivate Coding Forms
Day 1 Impact to Inactivate Coding Forms Clinical Teams ● Overview No With this release, Study Designers are able to delete Coding Configurations from the Control Center Vault even if it has Coding Requests. They can then deploy this Coding Configuration deletion to downstream Studies (for example, UAT
Slide 40: Safety Link
V Safety Link
Slide 41: Suspected ConMed
Day 1 Impact to Suspected ConMed Clinical Teams ● Overview No In some cases a Safety Case is caused by a ConMed and not the Study Drug. This feature allows the Site to indicate if a Linked Concomitant Medication to the SAE is just a Concomitant Medication or that it is suspected of causing the SAE.
Slide 42: Suspected ConMed
Day 1 Impact to Suspected ConMed Clinical Teams ● Date Entry Experience No Visibility Sites Configuration Studio Dependencies Item to Form Linking Copyright © Veeva Systems 2022 42
Slide 43: Codelist Mapper
Day 1 Impact to Codelist Mapper Clinical Teams No • Overview Study designers can now use CDASH codelist codes when designing Codelist items, and a safety administrator can configure Safety Link to map those codes to the appropriate values for the E2B XML. When Safety Link generates the E2B XML file fo
Slide 44: Codelist Mapper
Day 1 Impact to Codelist Mapper Clinical Teams No Visibility Safety Admin Configuration EDC Tools Dependencies NA Copyright © Veeva Systems 2022 44
Slide 45: Randomization
V Randomization
Slide 46: Option to Require Login Credential to Reveal Treatment
Day 1 Impact to Option to Require Login Credential to Reveal Treatment Clinical Teams No • Overview There is a new configuration option in Randomization setting that Site users will not have to enter login credentials to see the treatment Visibility • Use case Randomization Manager There is a lot of
Slide 47: CDMS User Community
CDMS User Community ● Interactive 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
Slide 48: Dedicated DEMO
For a dedicated demo of any Dedicated these features, DEMO please contact your Account Executive OR Customer Success Manager Copyright Copyright©© Veeva Veeva Systems Systems 2022 2022 48
Slide 49: Thank you
V Thank you