Slide 1: 20R1 Customer Webinar Studio & Admin
20R1 Customer Webinar Studio & Admin April 02, 2020
Slide 2: Sharon Lin, Cory Etzcorn
Sharon Lin Principal Product Manager, Veeva CDMS Cory Etzcorn Product Manager, Veeva CDMS
Slide 3: CDMS Product Team
CDMS Product Team Dennis Kochanski Rakesh Monassery Senior Product Manager, Senior Product Manager, Vault CDMS Vault CDMS Mohammed Al-Adeeb Quentin Paresys Senior Product Manager, Product Manager, Vault CDMS Vault CDMS Copyright © Veeva Systems 2020 3
Slide 4: Important Disclosures
Important Disclosures The following is intended to outline Veeva’s general product direction. It is intended for informational purposes only and does not form part of any contract. It is not a commitment to deliver any specific functionality and it should not be relied upon in making purchasing deci
Slide 5: Interact by using Chat
Interact by using Chat Copyright © Veeva Systems 2020 5
Slide 6: 20R1 Go Live
20R1 Go Live • ALL customer vaults upgraded to 20R1 APR • EU starts at 2:00pm PT • APAC & US starts at 5:00 PM PT Friday • May take up to 6 hours 17th Copyright © Veeva Systems 2020 6
Slide 7: 20R1 General Release Resources
20R1 General Release Resources Resources Available https://cdmshelp.veeva.com/lr/rn/general-releases/20r1/ • 20R1 Customer Release Preview Webinar Recording (Site Focused) • Webinar Slides are available for download • Abbreviated 7 min presentation for the Sites *Attending or Viewing the Site Focuse
Slide 8: Agenda
Agenda Thursday, April 02 20R1 Features Studio Demo Rules and Review Plan Editor Demo Admin Demo Recap Copyright © Veeva Systems 2020 8
Slide 9: 20R1 Feature Summary
20R1 Feature Summary Sites Study Designer Coding Admin • New Data Entry • Form Linking • setting • #define • Email Group Assignment Interface • Copy Rules from • Review Plan statement can Automated Auto- • Deploy Custom Objects & Roles • Progressive another Study Templates be added to coding • Flexi
Slide 10: 20R1 CDMS Features by Users
20R1 CDMS Features by Users Admin or Lead Data Sites Coding Study Designer Data Entry Tab Coding Tab Studio Mangers EDC Tools Copyright © Veeva Systems 2020 10
Slide 11: Feature Enablement Detail
Feature Enablement Detail Auto-On Features Configurable Features Visible • Sites • CRAs • Data Managers • Clinical Assessments • Coders Auto-On Configuration Support • Coder Admin • Admins Turned On Day 1 Turned Off Turned Off • Study Designers Automatically Requires Requires • Report Users availabl
Slide 12: Studio (Study Designer)
V Studio (Study Designer)
Slide 13: Form Linking
Form Linking Automatic • Overview Studio users can define links between forms, therefore allowing display of relationships. Most common use case AEs to ConMeds. − Link Multiple Forms – AE to ConMed to MedHistory − Link to same Form – AE to AE − Forms must be Repeating • Business Value Provides a bet
Slide 14: Copy Indication from Link
Copy Indication from Link Automatic • Overview Configure which form to copy the indication from, so sites have easy access to the indication through a couple of clicks. Most common example will be copying an Indication from an Adverse Event to a ConMed. • Business Value This will allows Sites to eas
Slide 15: Progressive Display
Progressive Display Automatic • Overview Study designers can design a form that can dynamically display or hide items based on a data collection point as a user progresses through a form. Supports hide/show or enable/disable at the Item or Item Group level. *Must be a codelist or boolean item type S
Slide 16: Item Indentation
Item Indentation Automatic • Overview Study designers can indent Items on a Form using the new Indent Level property. Can be used in conjunction with composite items and columns. • Business Value Indenting provides the site with a better user experience by visual grouping Visible STUDY DESIGNERS Cop
Slide 17: Copy Rules From Another Study
Copy Rules From Another Study Automatic • Overview Studio users can copy rules from another Study. Vault validates all identifiers in the copied rules and shows an indicator when a rule contains an invalid identifier. • Business Value Allows for rule logic to be reused as a template reducing develop
Slide 18: ODM Import/Export for Automated Deployment Studies
ODM Import/Export for Automated Deployment Studies Automatic • Overview ODM import and export functionality is available for use in automated deployment Studies (new deployment model). • Business Value Allows for the import of study designs from disconnected vaults, for importing standards or studie
Slide 19: Setup Email Group
Setup Email Group Automatic • Overview Define Email groups In Studio for Automatic Studies (new deployment model). This will help categorize the diff groups that emails should be sent out for notifications. • Business Value ONLY AUTOMATIC Helpful for commonly used email groups STUDIES Visible STUDY
Slide 20: Studio Demo
DEMO Studio Demo Copyright © Veeva Systems 2020 20
Slide 21: Rules
V Rules
Slide 22: Set Subject Status rules - Enhancement
Set Subject Status rules - Enhancement Automatic • Overview Study Designers will now select an event date or an item date when creating a Set Subject Status rule. When the subject is moved to the status specified in the rule, the value of the selected date is used to set the corresponding field of t
Slide 23: Send Email rules
Send Email rules Automatic • Overview Study Designers now have access to the “Send Email” rule action in which an email should be sent based on a rule, as well as defining the Subject and Message of that email. Tokens can be used in Subject and Message to include data from the current form (with som
Slide 24: Rule Editor enhancements
Rule Editor enhancements Automatic • Overview The Rule Details panel can now be collapsed/expanded to give more room to the expression editor. Study Designers have access to an “Items” tab on the right side of the editor, next to the Functions tab. It allows them to search for an item (by name or la
Slide 25: New functions in the Rule Editor
New functions in the Rule Editor Automatic • Overview Study Designers can now use the following functions in the Rule Editor: − Power(number1, number2): Returns the result of the first number to the power of the second number − StartOfDay(date, timezone): Returns the beginning of the specified day a
Slide 26: Reciprocal rules
Reciprocal rules Automatic • Overview Reciprocal rules change the way the expression engine is evaluating rules containing a fully qualified reference and a reference to a re-used form (using @Form). Before 20R1, if a rule was comparing a fully qualified reference (e.g. an event date or an informed
Slide 27: Example: Reciprocal Rule
Example: Reciprocal Rule PRE – 20R1 20R1 Create a Rule Create a Rule If Dosing Date on Dosing Form is less (earlier) than Consent Date, Same then fire a query on Dosing Form Date. Site Data Entry: Site Data Entry: Consent Date = March 15, 2020 Same Visit 1. Dosing Date = March 02, 2020 (Query fired)
Slide 28: Review Plan Editor
V Review Plan Editor
Slide 29: Optional Setting in the Review Plan Editor
Optional Setting in the Review Plan Editor Automatic • Overview The Optional mode can now be set in the Review Plan Editor. • Business Value Some customers have expressed the need to configure an “optional” review for certain forms and items. This is now available for event dates, forms and items in
Slide 30: Study templates for Review Plans
Study templates for Review Plans Automatic • Overview Study Designers can add study level templates for review plans, so that every newly created site will inherit those plans. Default and override values can be defined, as well as the subject numbers for overrides. The plan assignment can still be
Slide 31: Rules & Review Plan Editor Demo
DEMO Rules & Review Plan Editor Demo Copyright © Veeva Systems 2020 31
Slide 32: Admin
V Admin
Slide 33: Email Group Assignment
Email Group Assignment Automatic • Overview Assign study or non-study users to an Email Group created in Studio. • Business Value Users within and outside the study will receive an email notification when certain conditions are met. Visible ADMIN Copyright © Veeva Systems 2020 33
Slide 34: Automated Deployments – Custom Roles & Objects
Automated Deployments – Custom Roles & Objects Automatic • Overview Deployment of custom Vault objects and custom Study Roles can be included as part of study deployments. • Business Value Removes the need to manually reconfigure or use VPK to deploy custom Study Roles and custom objects in each env
Slide 35: Create a PRD Environment after Study Creation
Create a PRD Environment after Study Creation Automatic • Overview Deployment administrators can now create a Production-type environment (Study Instance record) from EDC Tools > Environments. • Business Value Deployment administrators can now create a production environment if one wasn't already cr
Slide 36: CDMS-CTMS Spark Integration
CDMS-CTMS Spark Integration Configuration • Overview With the Veeva Vault CTMS Connection, you can easily leverage operational data from your EDC vault for operational reporting within your CTMS vault. • Business Value Automated and near real time data sync between Clinical Operations and Data Manag
Slide 37: CDMS-CTMS Spark Integration
CDMS-CTMS Spark Integration Configuration CDMS CTMS Manually linked Study Study Site Site Study Study Country Country Events Visits existing Event Def Visit Def integration using View Subject Subject Sets milestones milestones Visible SDV/DMR SDV/DMR N/A Date* Date Copyright © Veeva Systems 2020 37
Slide 38: Study Designer & Designer Read Only Role
Study Designer & Designer Read Only Role Configuration • Overview The CDMS Study Designer role and CDMS Study Designer Read Only role is intended for creating and testing study designs. • Business Value A user no longer needs to have the Vault Owner security profile to design their study. Visible AD
Slide 39: Permission Updates
Permission Updates Automatic • Overview − View Form Linking and Edit Form Linking − Manage Study Role Permission − View Code − Workbench Tab ( *if enabled for your Vault) − Removed "Manage Study Lock" Permission from CDMS Deployment Administrator- Only CDMS Lead Data Manager • Business Value − More
Slide 40: Manage Custom Object Permissions in Role Management
Manage Custom Object Permissions in Role Management Automatic • Overview User Administrators can now manage Custom Objects with Read, Edit, and Delete permissions *Permission set required on the Security profile • Business Value This provides User admins the capability to define their own permission
Slide 41: Allow Deletion of Custom Study Roles
Allow Deletion of Custom Study Roles Automatic • Overview User Administrators can now delete custom Study Roles (in DEV) that don't have any users assigned that role. • Business Value Unused Study Roles can build up over time and create confusion when assigning roles to users. Visible ADMIN Copyrigh
Slide 42: Download Study Role
Download Study Role Automatic • Overview Users with access to Tools > Role Management can now download an Excel™ file with a report of which permissions are assigned to which Study Role. • Business Value Allows for easy documentation of an organization's Study Role permissions. Visible ADMIN Copyrig
Slide 43: Provide Federated ID during User Creation (UI)
Provide Federated ID during User Creation (UI) Automatic • Overview When creating and editing users from EDC Tools > Users, user administrators can now provide a Federated ID. • Business Value This change allows users to provide a Federated ID for a user account when creating users manually, empower
Slide 44: User Activity Report
User Activity Report Automatic • Overview The User Activity Report lists user actions and user login attempts in chronological order for a given time period. • Business Value Customers can track who had access to the system, thereby ensuring availability and compliance with data privacy and security
Slide 45: Active Version & Study Country during Site Creation
Active Version & Study Country during Site Creation Automatic • Overview Lead data managers can now create a Study Country when creating a new Site. An active casebook version can also be set during Site creation. • Business Value This removes the extra step of adding a Study Country to the Study be
Slide 46: Site-level SDV & DMR Re-assignment
Site-level SDV & DMR Re-assignment Automatic • Overview Lead data managers can now run the SDV Re-assignment and DMR Re-assignment jobs at the site level. • Business Value Run Review Plan jobs as needed at a Site level. Visible ADMIN Copyright © Veeva Systems 2020 46
Slide 47: CDMS 20R1 API
CDMS 20R1 API Automatic • Overview CDMS API (Application Programming Interface) allows users to interact with and retrieve data from the CDMS application. • Business Value Provide IRTs the ability to Set Subject Status and Create Event Groups. • List of 20R1 APIs • Set Subject Status API • Unset Sub
Slide 48: Emails Use Vault CDMS Logo
Emails Use Vault CDMS Logo Automatic • Overview All email notifications sent from Vault CDMS now include the Vault CDMS logo. Visible N/A Copyright © Veeva Systems 2020 48
Slide 49: Admin Demo
DEMO Admin Demo Copyright © Veeva Systems 2020 49
Slide 50: Recap
V Recap
Slide 51: New Data Entry Interface
New Data Entry Interface • Automatically enabled for New studies • Existing Studies must be enabled Copyright © Veeva Systems 2020 51
Slide 52: Form Enhancements
Form Enhancements Progressive Display Indenting Copyright © Veeva Systems 2020 52
Slide 53: Linking Forms and Copy Indications
Linking Forms and Copy Indications Form Linking Copy Indication Link Copyright © Veeva Systems 2020 53
Slide 54: Email Groups
Email Groups • Define Email Group in Studio • Add users to Email group in EDC Tools • Create a rule that triggers an email to the Group (eg. Serious Adverse Event occurs, an email gets sent to the Safety Email group) Copyright © Veeva Systems 2020 54
Slide 55: Rule Enhancements
Rule Enhancements Copy Rules Define what dates are associated to the Subject Status New Rule Functions • Power() • Sum() • Average() • StartofDay( date, New Items tab and Enhanced UI for Faster Rule Creation timezone) • Today(time zone) Copyright © Veeva Systems 2020 55
Slide 56: Optional Review Plans & Jobs
Optional Review Plans & Jobs • Create Review Plan with optional Reviews in Studio • Assign Review Plan to Site in EDC Tools – Review Plan Assignment • Run job – SDV Reassignment or DMR Reassignment for all sites or select sites to execute Review Plan Copyright © Veeva Systems 2020 56
Slide 57: Review Plan Template & New Sites
Review Plan Template & New Sites • Create a Review Plan Template in Studio so any new site inherits the Review Plan • Adding a new Site in EDC Tools can add a new Study Country and select active Casebook version at the same time. (these were previously separated) Copyright © Veeva Systems 2020 57
Slide 58: Deployments and Environments
Deployments and Environments Deploy Custom Objects & Custom Roles Add Production Environments at a later time Copyright © Veeva Systems 2020 58
Slide 59: Role Management
Role Management Permission Updates Study Designer Role(s) • View Form Linking and Edit Form Linking • Manage Study Role Permission • View Code Download Study Roles • Workbench Tab ( *if enabled for your Vault) • Removed "Manage Study Lock" Permission from CDMS Deployment Administrator Custom Object
Slide 60: User – Federated ID & Activity Report
User – Federated ID & Activity Report Federated ID for Single Sign On User Activity Report Copyright © Veeva Systems 2020 60
Slide 61: CTMS Spark Integration & APIs
CTMS Spark Integration & APIs Configuration CDMS CTMS Manually linked Study Study CDMS APIs to support integration to IRTs Site Site • Set Subject Status API • Unset Subject Status AP Study Study Country Country • Updates subject status to current status Events Visits • Create Event Group API Event
Slide 62: ODM Import/Export Data into Study
ODM Import/Export Data into Study Bring in external 3rd party standards or from a disconnected Vault • only in Automated Deployment Studies in Studio Copyright © Veeva Systems 2020 62
Slide 63: Thank you
Thank You Thank you