Table of Contents

• Title and Copyright Information
• Preface
  • Documentation accessibility
  • Related resources
  • Access to Oracle Support
  • Additional copyright information
• 1 What should I use this guide for?
• 2 Clinical One Cloud Service and Clinical One Digital Gateway 26.0.1
  • What's new in 26.0.1
    • Data collection
      • Upload video files to form questions
    • Integrations
      • Clinical One Digital Gateway integrations support rescreen visits
    • Reports, archives, and analytics
      • Enhancements to reports
      • Enhancements to Subject Data Extract with visit data
      • Enhancements to the Subject Forms dataset
      • Enhancements to the Study Design dataset
      • Enhancements to the Dh Metrics dataset
      • Clinical One Cloud Service now stores formatted text values without non-printable characters
    • REST API updates
    • Release impact on downstream systems
  • Fixed issues in 26.0.1
    • All users
    • Facilities, settings, and user management
    • Forms, visits, and rules
    • Integrations
    • Oracle Clinical One Analytics
    • Randomization and kits
    • Reports, archives, extracts, and notifications
    • Site users and subject data
• 3 Clinical One Cloud Service and Clinical One Digital Gateway 25.3
  • What's new
    • Data Collection
      • Limit the number of times a subject can be rescreened
      • Choose when subject numbers are assigned
      • Subject data can now be unverified
    • Integrations
      • Oracle Siebel CTMS Subject Visit (SV) integration - improved error message
      • Clinical One Digital Gateway integrations support rescreen visits
      • Oracle DMW now includes full audit records for kits chain of custody and dispensation
      • Shorter deprecation period for Clinical One Cloud Service Rest APIs
    • Reporting, archives and analytics
      • Enhancements to Oracle CRF Submit archives and reports
    • Randomization and Trial Supply Management
      • Define dynamic resupply strategies
      • Support for compounding shipments
      • New adaptive randomization schemas
      • Configure advanced dispensation for your study
    • Rules management
      • New rule helper functions
    • User experience
      • Open Clinical One Cloud Service directly to the page you need
  • Fixed issues
    • All users
    • Integrations
    • Oracle Clinical One Analytics
    • Facilities, settings, and user management
    • Randomization and kits
    • Reports, archives, extracts, and notifications
    • Site users and subject data
  • Release impact on downstream systems
  • Rest API updates
• 4 Clinical One Cloud Service and Clinical One Digital Gateway 25.2
  • Patch log
  • What's new
    • Data collection
      • Lock and unlock multiple subjects simultaneously
      • Upload and store any documents for your study
      • Restore and view deleted forms
    • Data review
      • Manage manual query closure by role
    • Integrations
      • File-based integrations now support file name format changes
      • Clinical One Cloud Service to Safety integration
      • Screen, randomize, and dispense data can be integrated before visit completion
      • The Multi-IWR integration has been simplified
      • The SAP Supply Management—Proof of Delivery integration supports alphanumeric characters in kit IDs
    • Notifications
      • New notifications in Clinical One Cloud Service
      • Customize your study's notifications
    • Randomization and trial supply management
      • Randomization replacement
      • Improved data entry workflows for Data Collection and Randomization and Trial Supply Management (RTSM)
    • Reporting, archives and analytics
      • New datasets to track sign, verify, freeze, and lock actions
      • New data element to track visit, form, and item level locks
      • Enhancements to Oracle Clinical One Analytics datasets
      • Enhancements to Oracle DMW clinical data extracts
      • Include a form preview in the Annotated Case Report Forms report
      • New Study Settings report
      • Rules report is now available in XLSX format
      • Subject Data Extract now includes forms with no data
      • Include subject event history in your Oracle CRF Submit Archive requests
      • Oracle CRF Submit Archives requests include uploaded documents
    • Rules management
      • Optimize custom rules by defining relationships between repeating forms
    • Study design
      • Configure predefined validation rules to raise queries
      • Future dates now raise queries when not allowed
      • Modify custom code lists in approved study versions
    • User experience
      • A fresh new Redwood look
      • Applying an advanced study version recalculates forms and visit statuses
    • User management
      • Update multiple study users simultaneously
  • Fixed issues
    • All users
    • Oracle Clinical One Analytics
    • Facilities, settings, and user management
    • Forms, visits, and rules
    • Integrations
    • Reports, archives, extracts, and notifications
    • Site users and subject data
  • Fixed issues in 25.2.1.5
    • Facilities, settings, and user management
    • Forms, visits, and rules
    • Integrations
    • Randomization and kits
    • Reports, archives, extracts, and notifications
    • Site users and subject data
  • Release impact on other applications
    • Patch set release impact for other applications
  • Rest API updates
    • Rest API patch updates
• 5 Clinical One Cloud Service and Clinical One Digital Gateway 25.1
  • Patch log
  • What's new
    • Data collection
      • Import Electronic Health Record (EHR) data
      • Update tabular forms included in live studies
      • Manage subject event related data and visits better
    • Data review
      • Trace queries for a target question
      • Include or exclude screen failed subjects from Source Data Verification
    • Integrations
      • Support for undoing subject events
    • Randomization and trial supply management
      • Add a sequence number to a randomization list
      • Assign kits from a lot to a manual shipment
      • Blind subject randomization numbers
      • Enhanced kits pooling for the quantum shipment model
      • Randomize subjects only when all required kits are present at the site
    • Reporting, archives, and analytics
      • Enhancements to Oracle CRF Submit archives and reports
      • Enhancements to the Projected Supply (Unblinded) report
      • Improved performance in Oracle Clinical One Analytics with new data elements to track data reliability
      • Review Source Data Verification (SDV) status across subjects and sites in Oracle Clinical One Analytics
    • User experience
      • Removed alerts for mismatch between visit date and screening date
    • User management
      • Update existing study users in bulk with an auto-populated template
  • Fixed issues
    • All users
    • Code lists
    • Facilities, settings, and user management
    • Forms, visits, and rules
    • Integrations
    • Oracle Clinical One Analytics
    • Randomization and kits
    • Reports, archives, extracts, and notifications
    • Site users and subject data
  • Release impact on other applications
    • Patch set impact on other applications
  • Rest API updates
    • Rest API patch updates
• 6 Clinical One Cloud Service and Clinical One Digital Gateway 24.2
  • Patch log
  • What's new in 24.2.1
    • New Projected Supply (Unblinded) report
    • Removed subjects no longer included in Subject PDFs for Oracle CRF Submit archives
    • Configure subject number integrations to Oracle InForm using the randomization number
  • What's new
    • Data collection
      • Easily include lab normal updates in existing forms
      • Design questions with an auto-lock
    • Integrations
      • Configure Clinical One Digital Gateway integrations to integrate data as of a specific date
      • Support for non-serialized inventory for integrations
    • Notifications
      • New notification for report server limit exceeded
    • Randomization and trial supply management
      • Allow depot-to-depot shipments for staging kits
      • Distribute non-serialized inventory
    • Reporting, archives and analytics
      • New Lab Normal Range report
      • Report data gets automatically purged
      • Enhancements to Oracle CRF Submit archives and reports
      • Control authoring access in Oracle Clinical One Analytics
      • Audit Trail dashboard in Oracle Clinical One Analytics
      • Support for queries on visit dates in Oracle Clinical One Analytics
      • Oracle Clinical One Analytics supports replacing a subject number with a randomization number
    • Rules management
      • Clear values on a form using custom rules
    • User experience
      • Study roles and permissions are now translated
  • Fixed issues
    • All users
    • Facilities, settings, and user management
    • Forms, visits, and rules
    • Integrations
    • Oracle Clinical One Analytics
    • Randomization and kits
    • Reports, archives, extracts, and notifications
    • Site users and subject data
  • Rest API updates
    • Rest API patch updates
  • Release impact for other applications
• 7 Clinical One Cloud Service and Clinical One Digital Gateway 24.1
  • Patch log
  • What's new
    • Data collection
      • Allow a future date in forms
      • Add instructional text
      • Create Drug Reconciliation forms
      • Enhancements to local labs
    • Data review
      • Manage all queries in one place
    • Integrations
      • Site time zone defaults to UTC when not defined in the source CTMS system
    • Randomization and trial supply management
      • Set exceptions to kits with the Do Not Dispense dispensation logic
      • Duplicate a randomization list
    • Reporting, archives, and analytics
      • Enhancements to Oracle CRF Submit archives and reports
      • Hide randomization details in the Study Design Report
      • New Subject Randomization Data Extract
    • Rules management
      • Access data not collected in forms
    • User experience
      • Quickly identify forms that require your attention
    • Other enhancements
  • Fixed issues
    • All users
    • Facilities, settings, and user management
    • Forms, visits, and rules
    • Integrations
    • Oracle Clinical One Analytics
    • Randomization and Kits
    • Reports, archives, extracts, and notifications
    • Site users and subject data
  • Rest API updates
    • Rest API patch updates
  • Release impact for other applications
• 8 Clinical One Cloud Service and Clinical One Digital Gateway 23.3 (December 2023)
  • Patch log
  • What's new
    • Data collection
      • Replace the subject number with the randomization number after randomization
      • Undo subjects added in error
    • Data review
      • Create queries on the visit date
    • Integrations
      • Enhancements to integrations
    • Site management
      • Manage sites, depots, and labs in one place
    • Randomization and trial supply management
      • Control depot users' access
      • Manage locally sourced kits
      • Pool kits easily across studies
    • Reporting, archives and analytics
      • Analyze your patients' data with the Subject Data Analysis dashboard
      • New Blinded Kits dataset in Oracle Clinical One Analytics
      • Create pixel-perfect reports using BI Publisher
      • Enhancements to Oracle CRF Submit archives and reports
    • Rules management
      • The clearChoice( ) helper function now clears data
      • Manage all custom rules in one place
    • User experience
      • Provide feedback on Clinical One Cloud Service
    • Other enhancements
  • Fixed issues
    • All users
    • Code lists
    • Forms, visits, and rules
    • Integrations
    • Oracle Clinical One Analytics
    • Reports, archives, extracts, and notifications
    • Sites, labs, depots, settings, and user management
    • Site users and subject data
  • Rest API updates
  • Release impact for other applications
• 9 Clinical One Cloud Service and Clinical One Digital Gateway 23.2 (September 2023)
  • Patch log
  • What's new
    • Data collection
      • Enhanced way of clearing dynamic questions and forms
      • Lock a subject
    • Data review
      • Auto-update of support template roles for existing studies
    • Integrations
      • Oracle Siebel CTMS (report) now supports the ability to map multiple form items
      • Screen fail enhancements
      • Disable sending verbatim terms to Oracle Central Coding for New or Screen Failed subjects
    • Reporting, archives, and analytics
      • Enhancements to Oracle Clinical One Analytics
      • Enhancements to Oracle CRF Submit archives and reports
      • Enhancements to Randomization and Trial Supply Management reports
      • Diversity & Inclusion dashboard in Oracle Clinical One Analytics
      • New Study Codelist datasets
    • Rules management
      • Predictive text in the Rule editor
    • Study design
      • Enhancements to library studies
      • Template role names include new unblinding label
    • User experience
      • Enhanced Chat & Help experience
    • Other enhancements
  • Fixed issues
    • All users
    • Facilities, settings, and user management
    • Forms, visits, and rules
    • Integrations
    • Oracle Clinical One Analytics
    • Randomization and kits
    • Reports, archives, extracts, and notifications
    • Site users and subject data
  • Rest API updates
  • Release impact for other applications
• 10 Clinical One Cloud Service and Clinical One Digital Gateway 23.1 (April 2023)
  • Patch log
  • What's new
    • Data collection
      • Manage screen failure subjects
    • Data review
      • Sign off at the form and visit level with custom affidavits
    • Integrations
      • Better shipment management for the Almac integration
      • Oracle Central Coding now supports a subject number change in an Clinical One Cloud Service study
      • Data Intake integration enhancements
    • Randomization and trial supply management
      • Tracking numbers for temperature excursions
    • Reporting, archives, and analytics
      • Enhancements to the Subject Data Extract
      • Enhancements to ODM-XML clinical data extracts
      • Enhancements to Oracle CRF Submit archives and reports
      • RTSM Dashboard in Oracle Clinical One Analytics
    • Rules management
      • Enhancements to rule helper functions
    • Study design
      • Create your very own library study
      • Preview forms in Draft mode
    • Other enhancements
  • Fixed issues
    • Forms, visits, and rules
    • Integrations
    • Oracle Clinical One Analytics
    • Reports, archives, extracts, and notifications
    • Sites, labs, depots, settings, and user management
    • Site users and subject data
  • Rest API updates
    • Rest API patch updates
  • Release impact for other applications
• 11 Clinical One Cloud Service and Clinical One Digital Gateway 22.4 (March 2023)
  • Patch log
  • What's new
    • Study design
      • Enhancements to code lists
    • Data collection
      • Link two-section form data
      • Enhancements to Source Data Verification (SDV)
    • Randomization and trial supply management
      • Create titrations with calculated doses
      • Screening and randomization limits by site
    • Integrations
      • Clinical One Digital Gateway productized integrations now support visit date change
      • Supply integration notification enhancement
      • TMMCS standard integrations through Clinical One Digital Gateway now support password rotation
      • Include commas in code lists for your integration configuration file
    • Reporting, archives, and analytics
      • New Randomization List (Blinded) report
      • Oracle CRF Submit archives and reports
      • Enhancements to Oracle Clinical One Analytics
    • Notifications
      • New enrollment notifications
      • Other new notifications
    • Other enhancements
  • Fixed issues
    • All users
    • Code lists
    • Facilities, settings, and user management
    • Forms, visits, and rules
    • Oracle Clinical One Analytics
    • Integrations
    • Randomization and kits
    • Reports, archives, extracts, and notifications
    • Site users and subject data
  • Rest API updates
• 12 Clinical One Cloud Service and Clinical One Digital Gateway 22.3 (November 2022)
  • Patch log
  • What's new
    • Data collection
      • Create and manage code lists for all studies at your organization
      • Clear saved data for a subject
      • Update a subject number during the study conduct period
      • Order studies using the company filters
      • Customize the welcome letters for users
      • Greater flexibility for date/time questions
    • Data review
      • Lock a subject's data at the question, form, or visit level
    • Randomization and trial supply management
      • Perform partial dispensation
    • Reporting, archives, and analytics
      • Access customizable dashboards
      • Enhancements for Oracle CRF Submit archives and reports
      • New notifications for scheduled reports
      • New User Assignment Across Studies report
    • User experience
      • Chat in real time with your Support team
      • Conduct studies in Simplified Chinese
    • Other enhancements
  • Fixed issues
    • All users
    • Facilities, settings, and user management
    • Forms, visits, and rules
    • Integrations
    • Oracle Clinical One Analytics
    • Randomization and kits
    • Reports, archives, extracts, and notifications
    • Site users and subject data
  • Rest API updates
• 13 Clinical One Cloud Service and Clinical One Digital Gateway 22.2 (June 2022)
  • Patch log
  • What's new
    • Data collection
      • Enhanced queries management experience
      • Hide the visit window projection
    • Randomization and trial management
      • Notification and report enhancements for shipment receipts
      • Organize kits by block numbers
    • Reporting and analytics
      • Future and skipped visits and forms data included in Oracle Clinical One Analytics datasets
    • Rules management
      • Helper functions for two-section forms
    • Other enhancements
    • Documentation updates
  • Fixed issues
    • Facilities, settings, and user management
    • Forms, visits, and rules
    • Integrations
    • Oracle Clinical One Analytics
    • Randomization and kits
    • Reports, archives, extracts, and notifications
    • Site users and subject data
• 14 Clinical One Cloud Service and Clinical One Digital Gateway 22.1 (April 2022)
  • Patch log
  • What's new
    • Integrations
      • Integrate screening and randomization data
    • Notifications
      • New rule for follow-up notifications on data changes
    • Randomization and trial supply management
      • Allow depots to supply other depots
      • Improved shipment receipt process
    • Reporting and analytics
      • New data fields added to Oracle Clinical One Analytics datasets
      • New Study Design Delta report in Oracle Clinical One Analytics
      • New Kit Chain of Custody (Blinded) report
      • Reports can now be scheduled
    • Rules management
      • Debug custom rules
    • User experience
      • Get a filtered view of your subjects
    • User management
      • Create user accounts in Clinical One Cloud Service
    • Other enhancements
  • Fixed issues
    • All users
    • Forms, visits, and rules
    • Integrations
    • Oracle Clinical One Analytics
    • Randomization and kits
    • Reports, archives, extracts, and notifications
    • Sites, labs, depots, settings, and user management
    • Site users and subject data
• 15 Revision history