Table of Contents
- Title and Copyright Information
- Preface
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1
Start here
- About the Oracle Empirica Signal application
- Prerequisites and usage notes
- Log in to Oracle Empirica Signal
- Set your user preferences
- Change your password
- Navigate Oracle Empirica Signal and Topics
- Enter information
- Drill down through data
- Work with tables
- Exit Oracle Empirica Signal
- View release notes and other documents
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2
Perform a Signal Review
- Signal Review basics
- Step 1: Select a signal configuration
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Step 2: Select a product, group of
products, or multiple products to investigate
- Start with the Signal Review Products page
- Investigate products in the Products table
- Group and filter products
- Configure columns for the Products table
- Find a product in the Products table
- Enter a note about a product
- Focus on a single product from the Products table
- Focus on multiple products from the Products table
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Step 3: Review product-event combinations
for a product or multiple products
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Start with the Product-Event Combinations
page
- View product-event combinations for a card or tab
- Configure columns for the product-event combinations table
- Limit the product-event combinations to a specific alert type
- Add a tab to the Product-Event Combinations panel
- Create a new view in the Add tab menu
- Apply actions to multiple rows with Select Rows mode
- Product-event combination statistics
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Investigate product-event combinations for
a single product or multiple products
- View the details of a Signal Review alert
- View product-event interactions
- View signals for similar product-event combinations
- View age group breakdown for a product-event combination
- View gender breakdown for a product-event combination
- Assign a reviewer to a product-event combination
- Add a comment
- Add a comment to multiple combinations
- View your signal review history
- Suppress a product-event combination
- Review product-event combinations from a multisource configuration
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Start with the Product-Event Combinations
page
- Step 4: Submit the review
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3
Use Oracle Empirica Topics
- Overview of topic management
- About topics, actions, and the calendar
- Display the Topic Management page
- Sections of the Topic Management page
- Sections of the Topics tab
- Sections of the Actions tab
- Sections of the Calendar tab
- Download the Topics or Actions table
- Keyboard shortcuts for the Topics and Actions tables
- Select a topic workflow configuration
- Choose which items to view on the Topics, Actions, and Calendar tabs
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Work with topics
- View topics
- Filter the Topics table
- View a specific topic
- Quickly access topic information
- Open a topic from the Recent Topics list
- View Topic and Edit Topic pages
- Edit the general information about a topic
- Add or view comments for a topic or action
- Add a topic
- Associate a topic with a product-event combination
- Select a topic template
- Make a topic visible to a work team
- Link topics
- Remove a link
- Reopen a topic
- Delete a topic
- View the history of a topic
- Viewing topic reports
- Create a topic PDF or ZIP file
- Work with actions
- Work with the calendar
- Work with attachments
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4
Initiate and monitor data mining runs
- What is a data mining run?
- View data mining runs
- Data Mining Runs page
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Create a Data Mining Run
- Step 1: Select the run type and data configuration
- Step 2: (For timestamped data only) Select the as-of date
- Step 3: Select the variables
- Step 4 for MGPS runs: Specify data mining parameters
- Step 4 for logistic regression runs: Select the events and specify drugs
- Step 5: Define data mining run options
- Step 6: Name the data mining run
- Step 7: Submit the data mining run
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Reference
- About MGPS runs
- MGPS computations
- MGPS independence model
- Information Component computations
- RGPS computations
- Use the PRR calculator
- PRR computations
- Select a case series for PRR computation
- ROR computations
- About logistic regression runs
- Logistic regression computations
- Logistic regression log files
- Guidelines for specifying drugs for logistic regression
- Drug and event hierarchies
- Timestamped data
- Specify an As Of date
- Stratification variables
- Dimensions and patterns
- View interactions
- Case scoring algorithm
- Increased frequency algorithm
- Manage custom terms
- Define subsets for an MGPS run
- View source data
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Manage data mining runs
- Rename a data mining run
- View details of a data mining run
- Arrange the columns on the Data Mining Runs page
- View jobs for a data mining run
- View job details for a data mining run
- Define a database restriction
- Refine a query to create a database restriction or custom term
- Cancel or delete a data mining run
- Re-run a data mining run
- Data configuration and object compatibility
- Publish a data mining run
- Data mining FAQs
- 5 Retrieve and review data mining results
- 6 Query the safety database
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7
Create and manage case series
- About case series
- Case Series page
- View existing case series
- Copy a case series
- Publish a case series
- Delete a case series
- Create a case series
- Work with case series
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Work with versioned case series
- About annotating a specific case
- Add or edit an annotation type
- Change the sort order of the annotation types
- Delete an annotation type
- Create a versioned case series
- Associate a versioned case series with a signal configuration
- Add annotations to a specific case in a case series
- View annotations for a case series
- View the details of a versioned case series annotation
- Work with annotations associated with a selected case
- Case series background processing
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8
Manage report definitions and output
- About reports
- Report structure
- View existing report definitions
- Built-in reports
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Create report definitions
- Create a report definition
- Step 1: Select a case series for a report
- Step 2: Name a report definition
- Step 3: Add rows and columns to a report definition
- Step 4: Specify a data source in a report
- Step 5: Specify content details
- Step 6: Preview a report
- Step 7: Run a report and work with report data
- Step 8: Save a report output
- Work with report definitions
- Specify report attributes/descriptors
- Specify variable breakdowns
- Report background processing
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Create and run interactive reports
- About interactive reports
- Interactive Reports page
- Create or edit an interactive report definition
- Run an interactive report
- Create a report definition file
- Run a report using a report definition file
- Query-based interactive reports
- Summary of all cases interactive reports
- Manage interactive reports
- Work with report outputs
- Work with report graphs
- 9 Set up and use drug profiles
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10
Settings and administration
- Specify settings
- View server version, versioning details, component libraries, and other documents
- View release notes and download other documents
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Manage users, login groups, and work teams
- Ways to administer users
- How user permissions work
- What superusers can do
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Manage users
- View existing users
- Display active licensed user counts
- Add or edit a user in a self-hosted environment
- Add or edit a user in an Oracle-hosted environment
- Assign roles to a user
- Assign permissions to a user
- Change user passwords
- Rename a user
- Change the authentication method for a user
- Delete a user
- Purge users
- Manage user profiles
- Manage user roles
- Manage work teams
- Use single sign-on
- Manage LDAP users
- Manage login groups
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Configure the system
- Select a data configuration
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Manage configurations
- About data configurations
- View existing data configurations
- Data configuration example
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Add a data configuration
- Add a data configuration
- Connect to an Oracle account
- Specify a drilldown map table
- Add a drilldown map table
- Select an Oracle table or column
- Source description table
- Narrative text
- Unique values table
- Specify hierarchy versions for timestamped data
- Import a data configuration
- Validate a data configuration
- Publish a data configuration
- Modify a data configuration
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Manage signal configurations
- About signal configurations
- Manage signal configuration reference data
- Manage Signal Configurations page
- Edit a signal configuration
- Publish or unpublish a signal configuration for a user with Manage Signal Configurations permission
- Publish or unpublish a signal configuration for superusers
- Configure alert types
- Manage monitored products
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Manage signal configuration
refreshes
- About refreshing signal configurations
- Signal Management Refreshes page
- Refresh a signal configuration from the Refresh Signal Management page
- Refresh a signal configuration using a definition file
- Access signal management refresh details
- View refresh details for a signal configuration
- View refresh details for a multisource signal configuration
- Cancel or delete a signal configuration refresh
- View jobs for a signal configuration refresh
- View job details for a signal configuration refresh
- Validate a signal configuration
- Manage signal comment types
- Assign reviewers to products
- Manage events and custom terms
- Manage signal views
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Manage multisource signal
configurations
- Get started with multisource signal configurations
- Add a multisource signal configuration
- Edit a multisource signal configuration
- Change a secondary configuration in a multisource signal configuration
- Review products from a multisource configuration
- Delete a multisource signal configuration
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Multisource signal configuration
FAQs
- How are products matched across configurations in a multisource signal configuration?
- Which configuration should I choose as the lead configuration in a multisource signal configuration?
- Can I change the underlying configurations in a multisource configuration?
- What is a connected configuration?
- How do I manage refreshes for a multisource configuration?
- What differences do I see when using Signal Review features with a multisource signal configuration?
- Why don't I see products from the secondary configurations in a multisource signal configuration?
- Why can’t I modify the column labels for secondary configurations in a multisource configuration?
- Why do I see warning messages on the Signal Review page when using a multisource configuration?
- How is auto-assigning to reviewers different for a multisource configuration?
- How does the Standardized MedDRA Queries (SMQ) option work
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Manage topic workflow configurations
- Topic workflow configuration design
- Overview of setting up a topic workflow configuration
- Preconfigured topic workflow configurations
- Manage Topic Workflow Configurations page
- Add a topic workflow configuration
- Edit Topic Workflow Configuration page
- Work with topic workflow configurations
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Manage fields
- About fields
- Manage Fields page
- View a field
- About managing the display order for fields and field values
- Add a field
- Add a multi-selection list field
- Add a drop-down list field
- Add linked fields
- Constrain field values by work team
- Identify a field as a filter field
- Edit a field
- Delete a field
- Modify the display order for a field
- Manage field values
- Manage topic states
- Manage action states
- Manage field access
- Manage topic templates
- Manage action types
- Manage email notification rules
- Manage subscription data releases
- Manage drug profile configurations
- Manage aliases
- Transform data
- Administer the system
- Monitor the system
- Set up saved lists