Slide 1: 21R2 Release Webinar: Studio, Admin, Coder
21R2 Release Webinar Studio, Admin, Coder July 15, 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 Lindsay Cory Etzcorn Chan Sharon Lin Monassery Product Manager Associate Pr
Slide 3: 21R2 Release Calendar
21R2 Release Calendar Sun Mon Tue Wed Thu Fri Sat 11 12 13 14 15 16 17 21R2 Release webinar JUL 9 AM PT - All Customers 10 AM PT - Studio, Admin, Coder 18 19 20 21 22 23 24 21R2 Pre-Release Validation Docs 04 25 26 27 28 29 30 01 02 03 04 05 06 07 AUG 08 09 10 11 12 13 14 21R2 General Release Custom
Slide 4: 21R2 Release Dates
21R2 Release Dates JUL AUG 19 09 Available Pre – Release Validation Docs 21R2 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 21R2 • Business es/21r
Slide 5: 21R2 Feature Summary
21R2 Feature Summary Sites Study Designer Admin Coding ● Editable Grids ● Annotated PDF ● Multi-Role Security ● Japan Support ● Restrict users that can close Enhancements ● Review Plan Assignment ● MedDRAJ system queries ● SDS Enhancements Enhancements ● JDrug ● Support SSO pop up ● Cross Vault Copy
Slide 6: Multi-Role Security
Multi-Role Security Predefined Roles ensure individuals have all necessary functionality to perform their responsibilities without manual configuration, testing, and validation of permission settings Multi-Role Security simplifies the setup and configuration of permissions for individuals who fulfill
Slide 7: Multi-Role Security
Multi-Role Security A phased implementation will roll-out availability across existing customers. New Vaults will have it automatically enabled. 21R2 21R3 Targeted Broad Initial Customers Availability Copyright © Veeva Systems 2021 7
Slide 8: 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 9: Studio
V Studio
Slide 10: Study Specification Enhancements
Day 1 Impact to Study Specification Enhancements Clinical Teams No • Overview − As part of the SDS and PDF changes, improvements were made to the Create Specifications Screen • Combined PDF options to reduce clicks Visibility • Added support for new features Study Designers • Business Value − Improv
Slide 11: PDF Enhancements
Day 1 Impact to PDF Enhancements Clinical Teams No • Overview • Added better support for EDC features and improved usability to include: − A summary page Visibility − A specification version Study − Better support for default Item Groups Designers − Codelist and Unit names in the annotations − Disab
Slide 12: SDS Enhancements
Day 1 Impact to SDS Enhancements Clinical Teams No • Overview • Made general enhancements to the SDS to improve usability and add support for new features Visibility − Added Event Group, Event, and Form names on the Schedule tree − Added Event Group on the grid Study − Carried down labels on Form De
Slide 13: Cross Vault Copy
Day 1 Impact to Cross Vault Copy Clinical Teams No • Overview − Allows users to copy objects across vaults that they have access to • Business Value Visibility Study − Improved study build times and better support for standardization Designers Configuration Studio Dependencies N/A Copyright © Veeva
Slide 14: SSO Support for Cross Vault Comparisons
Day 1 Impact to SSO Support for Cross Vault Comparisons Clinical Teams No • Overview − Removed the login required for comparing differences across two vaults • Business Value Visibility Study − Decreased user management effort, better Study Designer user experience Designers Configuration Studio Dep
Slide 15: Asynchronous execution for rules
Day 1 Impact to Asynchronous execution for rules Clinical Teams No • Overview A new “Asynchronous” parameter can be selected when creating a query rule. When such a rule is triggered, the system will put it in a queue for processing. The triggering action (e.g. form submit) will not wait for the res
Slide 16: Error console for asynchronous rules
Day 1 Impact to Error console for asynchronous rules Clinical Teams No • Overview When an asynchronous rule fails, the error message and the location of the error (e.g. which form submit triggered the rule) will be recorded. An error console is accessible in the Rules tab of EDC Tools for users with
Slide 17: Aggregate identifiers and functions
Day 1 Impact to Aggregate identifiers and functions Clinical Teams No • Overview The rule editor now allows study designers to use an asterisk within brackets in an identifier, to indicate that the values returned for that identifier need to be considered as an array of values. Visibility Aggregate
Slide 18: Admin
V Admin
Slide 19: Multi-Role Security
Day 1 Impact to Multi-Role Security Clinical Teams No • Overview Vault CDMS extends the current security model to allows users to have multiple Study Roles in the same Study. A user can have up to 15 distinct roles in a vault, either across the same study or across multiple studies. This model lever
Slide 20: Multiple Sites in Review Plan Assignment
Day 1 Impact to Multiple Sites in Review Plan Assignment Clinical Teams Yes • Overview With Targeted SDV (Source Data Verification) and DMR (Data Management Review), your organization can define SDV or DMR requirements for a subject in a Review Plan. You can now configure overrides for Each Site, For G
Slide 21: Early Study Access
Day 1 Impact to Early Study Access Clinical Teams Yes • Overview If a Casebook Definition does not yet exist for a Study, the Active Version field on Sites is no longer required. This allows users to configure and begin training for a Study before a study design is complete. The Get Enrollment check no
Slide 22: Study Role Enhancements
Day 1 Impact to Study Role Enhancements Clinical Teams Yes • Overview We made several improvements to the available permissions and standard Study Roles. We added the following new permissions: Visibility ● View Users: Controls the ability to view Users Study Admin ○ Assigned to the standard CDMS Us
Slide 23: Study Role Enhancements (contd)
Day 1 Impact to Study Role Enhancements (contd) Clinical Teams Yes We granted the View Casebook permission to all Study Roles, both standard and custom, that have the Data Entry permission assigned. We granted the View Casebook, Schedule Reports, and Reports Dashboards Tab permissions to the CDMS Vi
Slide 24: API Enhancements
Day 1 Impact to API Enhancements Clinical Teams Yes We have 3 new APIs. ● Retrieve All Users API (new version) ○ GET /api/v21.2/app/cdm/users?study_name={study_name}&user_name={user_name} Visibility Study Admin ● Open Query by Item Record ID ○ POST /api/{version}/app/cdm/items/actions/openquery Conf
Slide 25: CDMS to CTMS Connection: Protocol Deviations
Day 1 Impact to CDMS to CTMS Connection: Protocol Deviations Clinical Teams No • Overview Protocol Deviations created in Vault CDMS can now be configured to flow into Vault CTMS via the Spark Connection. Once configured, creating or updating a Protocol Deviation in CDMS (either programmatically or m
Slide 26: Reports
V Reports
Slide 27: Study Data Extracts Enhancements
Day 1 Study Data Extracts Enhancements Impact to Clinical Teams • Overview No Enhancements to the SDE including: − Option to use the External ID instead of item names as column headers − Option to split clinical Datetime item columns into two separate Date and Time columns Visibility − Option to inc
Slide 28: Study Data Extracts Enhancements
Day 1 Impact to Study Data Extracts Enhancements Clinical Teams • Overview No New System Datasets • Business Value Visibility Users have access to new dataset files when Assessments, Local Labs, Protocol Deviations, and Randomization modules are enabled Lead Data Managers Description Dataset Name As
Slide 29: Coder
V Coder
Slide 30: MedDRAJ
Day 1 Impact to MedDRAJ Clinical Teams No • Overview Vault Coder offers MedDRAJ to code and autocode Japanese Adverse Events and Medical History terms. It can autocode from the Dictionary and the Synonym List. Visibility Coders can search the Dictionary using Kanji, Hiragana, and Katakana scripts to
Slide 31: JDrug
Day 1 Impact to JDrug Clinical Teams No • Overview Vault Coder offers JDrug to code and autocode Japanese medications. It can autocode from the Dictionary and the Synonym List. Visibility Coders can search the Dictionary using Kanji, Hiragana, and Katakana scripts to code in Japanese. Both Coder Adm
Slide 32: Safety Link
V Safety Link
Slide 33: Multiple SAEs per Case
Day 1 Impact to Multiple SAEs per Case Clinical Teams No • Overview Safety Link can now be configured to include multiple Serious Adverse Events in a single Safety Case. This is helpful when capturing a series of related SAEs. For example, if a subject was hospitalized for a heart attack and then, a
Slide 34: Integration Enhancements
Day 1 Impact to Integration Enhancements Clinical Teams No • Overview Safety Link now offers the ability to indicate that the Investigational Product is blinded. It is able to identify the MedDRA version and is configurable to use a NullFlavor of 99999999 for coding. Visibility • Business Value Safe
Slide 35: Randomization
V Randomization
Slide 36: Rules: Send email once Subject is Randomized
Day 1 Impact to Rules: Send email once Subject is Randomized Clinical Teams No • Overview For studies with Randomization enabled, a rule to can be created for an email to be sent once subject is Randomized Visibility • Business Value Study Designers Notify relevant parties by email when subject is r
Slide 37: 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 38: 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 38
Slide 39: Thank you
V Thank you