Slide 1: 21R1 Customer Webinar: Studio, Admin, & Coder
21R1 Customer Webinar Studio, Admin, & Coder March 25, 2021
Slide 2: CDMS Product Managers
CDMS Product Managers Dennis Mohammed Quentin Abhi Kochanski Al-Adeeb Paresys Yeleswarapu Sr. Product Sr. Product Sr. Product Product Manager Manager Manager Manager Migrations Studio, Library Coder, Safety Rules Link Rakesh Andrea Cory Etzcorn Krueger Sharon Lin Monassery Product Manager Associate
Slide 3: 21R1 Release Calendar
21R1 Release Calendar Sun Mon Tue Wed Thu Fri Sat 21 22 23 24 25 26 27 21R1 Release webinar 21R1 Pre-Release MAR 9 AM PT - All Customers 10 AM PT - Studio, 5PM PT Admin, Coder 28 29 30 31 01 02 03 Validation Docs APR 04 05 06 07 08 09 10 11 12 13 14 15 16 17 21R1 General Release 5PM PT 18 19 20 21 2
Slide 4: 21R1 Release Dates
21R1 Release Dates MAR MAR APR 26 29 16 Resources Available Pre – Release Validation Docs 21R1 Release https://cdmshelp.veeva. com/lr/rn/general-releas • Starts at 5PM PT • Located in • All Customers Vaults es/21r1/ • Clone of UAT VeevaDocs upgraded to 21R1 • Special Request for • Validation Project
Slide 5: 21R1 Feature Summary
21R1 Feature Summary Sites Study Designer Admin Coding Randomization ● Protocol ● Library ● Vault Level User ● Coder Approval ● Emergency Deviations Collection and Mgmt. Workflow Unmasking ● SSO Report ● Job ● Group Querying Report Integrations Enhancements ● Preferred Base ● Exports and ● Minor for
Slide 6: Protocol Deviations
Protocol Deviations Fit-for-purpose design to collect, review, and manage PDs eliminates complexity of work-arounds – tagging queries or hidden forms Automate Simplify Programmable Deviations Observable Deviations ✔ Precision tracking, complete traceability ✔ Easy for sites and monitors to report de
Slide 7: Library Collections
Library Collections Visibility and ease-of-use that support a robust standards program Tracking of usage Dedicated interface Library collections and deviations for librarians Faster study builds. Visibility that helps Greater ease-of-use, Controlled introductions enforce adherence and especially man
Slide 8: CDMS Safety Link
CDMS Safety Link Automation increases speed and data quality with less effort Reduces manual Complete, Keeps safety system On-time Fit for purpose processes and high-quality current without a lot transmission reports duplicate data entry information of noise Sites simply submit Data is drawn from Co
Slide 9: CDMS Safety Link
CDMS Safety Link Automate transmission of new SAE cases and related updates E2B R3 MDN & ACK2 No Coding Easier to Manage Builds Foundation Easily configurable No AS2 gateway Supports future visibility connections No certification mgmt and case management No IP address white labeling enhancements Cop
Slide 10: Feature Enablement
Feature Enablement Impact to Clinical Team DAY On Day 1 of the Release, will the Study Clinical Team (Sites, CRAs, Data Managers) see it? 1 Options: Yes or No Visibility On Day 1 of the Release, which users see it? Options: Sites, CRAs, Data Managers, Study Designers, Study Admin (Deploy, Safety, Us
Slide 11: Studio
V Studio
Slide 12: Protocol Deviations - Configuration
Day 1 Impact to Protocol Deviations - Configuration Clinical Teams No • Overview Studies can now enable a new Protocol Deviations feature for creating deviations and linking to study data within Vault CDMS. This feature is behind a study setting that defaults to off for existing and new studies, but
Slide 13: Linked Rules
Day 1 Impact to Linked Rules Clinical Teams ● Overview No ○ The rule editor allows study designers to access data from a linked form only, instead of having to consider all matching forms for a subject. Visibility I.e. a rule can now be written to only check against ConMed forms linked to an AE form
Slide 14: Study Data Extracts
Day 1 Impact to Study Data Extracts Clinical Teams Yes • Overview This report will allow Lead Data Managers to have access to all Clinical Data in a form including system data (e.g., operational, queries, etc.) in EDC tools. Users will have the option to download the data as a SAS or CSV file and se
Slide 15: Library
Day 1 Impact to Library Clinical Teams No • The first of a series of library features, the first is comprised of the following: − A Library tab and the ability to create Library Collections − Casebook definition source tracking and basic reporting − Librarian Role Visibility Librarian • Business Val
Slide 16: Admin
V Admin
Slide 17: Procedure Notifications for Vault CTMS
Day 1 Procedure Notifications for Vault CTMS Impact to Clinical Teams No • Overview EDC can now transmit mapped submitted Procedures to Vault CTMS, used for payments when this integration is enabled. Customers must map Procedures on a study-by-study basis in EDC Tools. EDC creates a Procedure record
Slide 18: Vault Level User Management
Day 1 Impact to Vault Level User Management Clinical Teams No ● Overview User management is now at the vault level. User administrators may create user accounts and assign study access to any studies in that vault from one location (Tools > System Tools > Users). They can also reset a user’s passwor
Slide 19: Job Enhancements
Day 1 Impact to Job Enhancements Clinical Teams Yes ● Overview Users can cancel an in progress Core Listing, Retrospective Amendment, Labs Mass Updates, or Data and Definition Export job. Users can refresh the Job History without refreshing the entire page. Visibility After 21R1, any output or job l
Slide 20: Protocol Deviations - Security
Day 1 Impact to Protocol Deviations - Security Clinical Teams No ● Overview ● Permissions ○ View Protocol Deviations: Ability to view Protocol Deviations from Review > Protocol Deviations (CDMS Clinical Research Associate, CDMS Data Manager, CDMS Lead Data Manager, Visibility and CDMS Auditor Read O
Slide 21: Library - Security
Day 1 Impact to Library - Security Clinical Teams No ● Overview ○ Permissions ○ View Library (New) ○ Design Library (New) Visibility Study Admin ○ Role Changes ○ CDMS Librarian (New) - available only in non-Production environments ○ CDMS Study Designer and CDMS Study Designer Read Only has access to
Slide 22: Safety - Security
Day 1 Impact to Safety - Security Clinical Teams No ● Overview ○ New Permissions ○ Manage Safety Configuration (New) ○ Design Library Visibility Study Admin ○ Role Changes ○ CDMS Safety Administrator (New) - EDC Tools Tab, Studio Tab, Reports Tab, Systems Tab, View Study Design, Manage Safety Config
Slide 23: CDB - Security
Day 1 Impact to CDB - Security Clinical Teams No ● Overview ○ New Permissions ○ Edit CQL, Modify Listing, Create Listing, Delete Listing, Generate CSV, Public Access, View Listings, View Visibility Queries, View Export, Create Export Definition, Generate Export Package, Delete Export Definition, Vie
Slide 24: Coder - Security
Day 1 Impact to Coder - Security Clinical Teams No ● Overview ○ New Permissions ○ Approve Code (New) - granted to CDMS Coder Manager and CDMS Coder Administrator. Visibility ○ Role Changes Study Admin ○ CDMS Coder Manager (New) - Coder Tab, Reports & Dashboard Tab, Open Query, Close Query, Schedule
Slide 25: Repeating Events to CTMS
Day 1 Impact to Repeating Events to CTMS Clinical Teams No ● Overview When Events come over to CTMS via the Spark Connection, each event has the same name. For example - For an Oncology study, you might have Day 1, Day 5, Day 15, and then another Day 1, Day 5, Day 15 for the same subject. Some custo
Slide 26: Coder
V Coder
Slide 27: Select All Forms for Batch Upversioning
Day 1 Select All Forms for Batch Upversioning Impact to Clinical Teams No • Overview In Batch Upversioning, users can now select more than twenty (20) forms to batch upversion using the new “Select All Forms on All Pages” option. Visibility • Business Value Coders This change allows easier and faste
Slide 28: Preferred Base for Reports & Extracts
Day 1 Impact to Preferred Base for Reports & Extracts Clinical Teams No • Overview Coder now supports the storing of Preferred Base. The Preferred Base further normalizes WHODrug Coding by storing the Preferred Name without the Salt or Ester. Common Salts or Esters are “Hydrochloride”, “Sodium”, or
Slide 29: Group Queries
Day 1 Impact to Group Queries Clinical Teams No • Overview Coders can open queries on a Code Request Group while in Group view. Opening a query on a Group opens a query on each Code Request in the Group. Visibility As part of this feature, we added a Study Setting that expands the Grouping criteria
Slide 30: Approval Workflow
Day 1 Impact to Approval Workflow Clinical Teams No • Overview When manual coding needs to be reviewed by a more experienced member of the team, you can enable the Approval Workflow. It is a Study Setting. When enabled, all manual coding must be approved. Visibility Coder After a coder assigns a cod
Slide 31: Randomization
V Randomization
Slide 32: Unmasking Report
Day 1 Impact to Unmasking Report Clinical Teams Yes • Overview For studies with Randomization enabled, there is a report that will list every time an emergency unmasking occurred. Visibility • Business Value Lead Data Manager This will provide visibility in who, when, and why an unblinding occurs Co
Slide 33: Search, Filter, Export Randomization Listings
Day 1 Impact to Search, Filter, Export Randomization Listings Clinical Teams Yes • Overview For studies with Randomization enabled, lists can be exported • Business Value Visibility Lead Data An easy way to export data. Manager, Randomization Manager Export Filter Search Randomization List X Configu
Slide 34: Dedicated Demo
For a dedicated demo of any Dedicated these features, DEMO please contact your Account Executive OR Customer Success Manager Copyright © Veeva Systems 2020 34
Slide 35: Thank you
V Thank you