Title and Copyright Information
Preface
- Documentation accessibility
- Diversity and Inclusion
- Related resources
- Access to Oracle Support
1 About Oracle Site Activate
- Run an audit trail report
2 About your user login and profile
3 About study countries
- View study country details
- Favorite a study country
- Add a new study country
- Edit number of planned sites for a country
- Delete a study country
4 About study sites
- Add a new site
- Add multiple new sites
- View site details
- Favorite a site
- Change a site's status
- Change a site's information
- Add site staff
- Edit staff contact details
- Replace the principal investigator
- Reverse PI replacement
- Change site staff names
- Review quarantined files uploaded by sites
- Track ad hoc documents
5 About activity alerts
- View your alert list
- Respond to alerts
- Complete individual alerts
- Customize alert email notifications
- Pause your alerts for an item
- Complete activities in bulk
6 About notes
- Add a note
- View a previous item note
- Change a note
7 About documents
- Generate document and submission activities
- Run workflow to generate document activities
- Generate protocol amendment activities
- Complete document activities individually
- Upload document files for an individual activity
- Replace file attachment
- View document information
- Add a document description
- Add a document expiration date
- Manage expiring documents and submissions
- Add a new document version
- Add an associated document version
- Discontinue a document
- Disable an incorrect document
- Reenable a document
- Delete a document placeholder
- Change a document completion date
- Set dates for multiple documents
- Add an ad hoc document
- Manually export documents and add a new section
- Preview a document
- Annotate a document
- Correct document item metadata
8 About study library
- Share study level document with all study countries
- Share study level document with newly added countries
- Enable/disable automatic document distribution from library
- View countries with which a document is shared
- Find existing protocol versions
- Share and reshare individual documents with countries
- Organize study files with document groups
- Remove unshared documents
9 About electronic signature
- Enable or disable electronic signature at the country level
- Enable or disable electronic signature at the study level
- Tag document or contract for electronic signature
- Sign items in Adobe Sign - Oracle Site Activate
- Sign items in Adobe Sign - email notification
10 About eTMF in Oracle Site Activate
11 About submissions
- Add submission packages
- Add submission subcommittees
- Order submission package files
- Track submission status
- Set submission Type and Category
- Track planned submission dates
- Plan submission dates in bulk
- Mark submission activities complete
- Enter submission dates in bulk
- Generate document and submission activities
- Include sites for submission to a central authority
- Set submission Type and Category
- Export submission package documents
- Publish Submission package files to eTMF
- Upload or download submission agency CSV
12 About study level submissions
- Define an EU submission validation package
- Define an EU submission Part 1
- Define an EU submission Part 2
- Filter documents in an EU submission package
- Review and confirm countries for EU submission validation or Part 1 package
- Review and confirm countries and sites for EU submission Part 2 package
13 About milestones
- Set milestone dates from country and site details pages
- Set and change milestone dates from the home page
- Correct a baseline milestone date
- Replan milestone dates
- Determine impact of milestone date change
- Show or hide milestones on the timeline
- Mark a milestone at risk
- View Summary Milestones
- Export Summary Milestones
14 About contracts
- Complete contract activities
- Add a contract or budget note
- View and edit contract or budget notes
- Process a contract amendment
- Manage expiring contract items
- Discontinue or reinstate a contract item
- Export contract documents
15 About IP release
- Compile an IP release package
- Review an IP release package
- Download an IP release package
- Add or replace a document version
16 About bulk actions
- Navigate to bulk work and filter by items or activities
- Filter items or activities by study, country, and site
- Filter items or activities by role, item type, activity type, or text search
- Perform actions on individual document items
- Perform bulk actions on filtered document items
- Perform bulk actions on individual activities
- Perform bulk actions on filtered activities
- Plan milestones and submissions in bulk
17 About partner collaboration
- Establish a partner relationship
- Accept a request to establish a partner relationship
- Set Portfolio overview as your default view
- Dissolve a partner relationship
- Seed external users
- Assign a partner View Only access
18 About study setup
- Add new studies
- Set study status
- Edit study attributes
- Favorite a study
- Generate study level items
19 About user accounts, roles, and permissions
- Assign or unassign a role for one team member
- Assign team members for study, country, and site
- Self-assign an activity
- Change an assignment
- Add new team member accounts
- Deactivate or reactivate a user account
20 About API Integration
- Access API documentation
- View event messages
- Retry a single failed event message
- Retry a successful event message
- Download event messages to CSV
- Create publishing endpoint with standard authentication
- Create publishing endpoint with basic authentication
- Create publishing endpoint with OAuth 2.0 authentication
- Edit an existing endpoint
- Delete an endpoint
- Configure custom eTMF attributes
- Review files in IRB documents queue
- Match an IRB file or add new item