2 Impact analysis

Review a summary of the business and functional impact for enhancements in the 25.1 release.

Enhancement Enablement setting Impact

User experience

Navigation and usability

None Provides improved navigation for a more streamlined user experience

User experience

Global and persistent menus

None Faster access to key features improves productivity

User experience

Site and study loading messages

None Displays informative messages during loading or when no data is found, improving transparency for users

Account settings

Account users and access

Yes - User and Role Management permission Easier to manage users, roles, and teams with a clearer and organized layout

Account settings

Account level email templates and settings

None Organizes email configuration into tabs for easier editing, previewing and branding across studies

Account settings

Account workflow templates

Yes - Account workflow template management permission Makes it easier to create, edit and manage reusable task templates with a cleaner interface

Account settings

Account integrations

Yes - API and Authentication Management permission Centralizes API, event notifications, and authentication settings into a single streamlined interface for easier configuration and troubleshooting

Account settings

Account networks

None Provides a cleaner layout and easier management of networks with improved visibility, search, and delete options

Account settings

Account support link configuration

None Updates a support link text to reflect Oracle Life Sciences branding for consistent user experience

Datasources

Create, map, and clone datasource definition

Yes - Data Source Management role permission Enhances usability with a new definition tab and guided steps to define, map and publish data sources more efficiently. Allows users to reuse existing datasources, reducing setup time and minimizing errors.

Datasources

Create a new datasource

Yes - Data Source Management role permission Provides more intuitive starting point with autosave and immediate access to mapping tools once a schema is uploaded

Datasources

Add or update flat datasource records via CSV

Yes - Data Source Management role permission Enables bulk record management through CSV uploads, simplifying updates and saving time

Datasources

Matches table

Yes - Data Source Management role permission New datasource column added to the Matches table, improving visibility into the source of each matched record

Datasources

Loading message

Yes - Data Source Management role permission Displays context-specific messages during loadings, helping users understand system status

Datasources

Quick links

Yes - Data Source Management role permission Clarifies which datasources are actionable by hiding quick links for unpublished datasources

Document management

Document submissions page

Yes - When you have any of the following permissions, you can access the new page from the Study > Document submissions menu item:
  • Negotiation for assigned CDA/Document submissions only
  • Review and Approve All CDA/Document Submissions
  • Review and Approve Assigned CDA/Document Submissions Only
  • Read only document management view
Simplifies document tracking and review with filters, exports, and version history

Document management

Survey submission PDF history

Yes - Site nomination permission to grant access to the study’s Document submissions page Enables viewing, filtering, and bulk downloading of survey submission PDFs, improving document management and auditability

Email communications

Invitation received modal

None Improves the invitation experience by displaying recipient names consistently sourced from the site grid and site profile, improving clarity in site communications

Email communications

Study email templates

Yes - Email template management permission Simplifies email template management and accordion controls, making it easier to configure and customize study notification emails

Feasibility surveys

Total survey points

None Displays total possible survey points in the site grid and survey response modal for better scoring visibility

Feasibility surveys

Alchemer login

None Adds direct link to Alchemer login for easy survey access

Feasibility surveys

Survey PDF downloads

None Improves survey PDF exports with detailed footer info including submission version and timestamps

Feasibility surveys

Survey submission message

None Enables rich text formatting and updates to survey submission message for clearer communication

Feasibility surveys

Account-level default survey scoring

Yes - user must have permissions to Account management page to enable scoring settings Adds account-level default scoring settings to control how survey questions are scored

Feasibility surveys

Survey scoring configuration

None Requires confirmation when updating Alchemer surveys to prevent scoring configuration mismatches

Site communications

Cross-study message icon

New message drawer

Threaded message with Reply

None Enhances collaboration with a new cross-study message icon, centralized message drawer, and threaded replies for better tracking and streamlined communication across studies

Site details drawer

General functional enhancements

None Enhances usability with cleaner layout, improved visibility of key site info, and faster access to study actions

Site details drawer

Site assignment, Workflow close, and Network picker

None Streamlines site management by allowing direct site assignment, easier workflow closure and intuitive network selection from the site details drawer

Site details drawer

Site visit date picker

None New date picker control added to capture planned site visit dates, making it easier to track and update visit scheduling information

Site details drawer

Document workflow tasks

Yes -
  • Review and Approve All CDA/Document Submissions permission: allows you to open the modal for all sites
  • Negotiation for assigned CDA/Document submissions only permission: allows you to open the modal only if you are assigned as a CDA reviewer for the document task or you are the site-assigned user
  • If you have only the Review and Approve Assigned CDA/Document Submissions Only permission and not the Negotiate or all CDAs permission, you cannot see the Review actions link/modal if you are not the user assigned as a CDA reviewer or the site-assigned user for the document task
  • An Oracle Site Select user with the Read only site grid view permission will not see the Review action link
  • An Oracle Site Select user with the Read only document management view and either the Read only site grid view or the Site nomination permission can open the review modal, but not complete the task

Additionally, please note the following related to CDA permissions:

  • A user with the Negotiation for assigned CDA/Document submissions only permission cannot finalize/Final approve a CDA task without also having one of the “Approve” CDA permissions as well
  • If an Oracle Site Select user has ‘Review and Approve Assigned CDA/Document Submissions’, then they can see the modal for all site's CDA documents.
  • If an Oracle Site Select user has ‘Negotiate or all CDAs’ then they can only see the modal where the user is assigned as the CDA reviewer or the site-assigned user. The user will not be given the option to Final approve the CDA.
Introduces a new actions and history drawer that centralizes task actions and version history improving reviewer efficiency and visibility into document activity

Site grid

Site grid design

Workflow column and details drawer access

Task completion modal

Survey results column

Site invitation and Site portal status

Final approve CDA task in Workflow drawer

Yes - Allow external completion of workflow tasks permission Improves overall site list usability with better filters, sorting and layout updates that make it easier for users to find and manage site data across studies

Site grid

Site grid filter selection

Multi-select filter for Site Progress CDA Status column

None Adds new filtering options and improves filter layout, enabling users to narrow results more precisely and manage sites more efficiently

Site grid

Unavailable sites message

None Displays a clear message when no sites meet the current setup criteria, helping users quickly understand why the site list appears empty

Site grid

Revert site finalization

Exclude, finalize, and migrate site confirmation modals

Yes - Site nomination permission, Revert site finalization permission Allows users to revert final acceptance/final decline decisions, offering greater flexibility in managing site selection workflows and correcting errors if needed

Site grid

Assign site user modal

None Introduces a streamlined modal for assigning Oracle Site Select users to study sites, improving efficiency and consistency in managing sites

Site grid

View site history

None Provides users with a centralized view of site history, improving visibility of site history information

Site grid

Site document download

None Enables users to download the latest version of the submitted site documents from any bucket state

Site grid

CDA task status icons

None Visual status indicators on CDA tasks, allowing users to quickly assess progress

Site grid

Site grid CSV extract

None Allows users to export the site grid view to a CSV file, making it easier to share, analyze or archive site data outside the application

Site portal

Site portal user interface

myStudies dashboard

Communications

Documents

Completed workflow tasks

None Delivers a modernized and more intuitive experience for site users with a redesigned interface and streamlined access to key study information, including dashboards, messages, documents, and completed tasks-enhancing usability and site engagement

Site profile

Configurable site profile

None Enables customization of the site profile layout and fields, allowing customers to tailor data views to their workflows and capture site-specific information more effectively

Site profile

Document library

Yes - Upload files to a site’s document library permission Centralizes access to important study documents, improving visibility and making it easier for users to find and reference shared content.

Site profile

Trial history

None Provides a detailed view of a site's past participation in trials, helping users evaluate site experience and inform site selection decisions

Study setup

Study workflow configuration

None Allows users to define and tailor study-specific workflows, improving alignment with organizational processes and enhancing operational efficiency

Study setup

Study workflow documents

Yes - CDA/Document Template Upload permission, Study Setup Management permission. If you have both, or the Read-only Study Setup permission, you’ll see everything. Enables management of workflow-associated documents within the study, supporting better organization, version control, and traceability across goals

Study setup

Study milestones

None Improves usability by repositioning the row to its related input fields for better context and clarity

User management

User permissions

Yes -

Three new user permissions that separate the Confidentiality Statement, CDA and Survey tasks from the general Not Required permission.

Complete task as Not required: Sign and return CDA, Complete task as Not required: Feasibility survey, Complete task as Not Required: Confidentiality Statement

Two new permissions in the CDA/Document Management permission group.

Review and Approve All Generic Document Submissions, Review and Approve Generic Document Submissions for assigned sites Only

Existing CDA permissions will automatically receive one of the new generic document permissions as follows:

  • Users with Negotiation for assigned CDA/Document submissions only or Review and Approve All CDA/Document Submissions will now have Review and Approve All Generic Document Submissions permission
  • Users with Review and Approve Assigned CDA/Document Submissions Only will now have Review and Approve Generic Document Submissions for Assigned Sites Only permission
Introduces new permissions allowing users more control and flexibility managing workflow tasks, generic document review roles

User management

Study names

Yes -Study details management and Account study creation permissions Updates permissions required to edit study names, improving control and security over study information