Contents

 
About this guide
Overview of this guide
Audience
Documentation
Documentation accessibility
If you need assistance
Finding InForm information and patches on My Oracle Support
Creating a My Oracle Support account
Finding information and articles
Finding patches
Finding Oracle documentation
Finding Oracle Health Sciences documentation
Finding other Oracle documentation
Finding prerequisite software for Oracle Health Sciences applications
InForm overview
About the InForm software
About the Data Viewer
About the Reporting and Analysis module
InForm system configuration
InForm users
Case report forms
Form types
Form association
Dynamic forms, dynamic visits, and alternate forms
Form views
Item types
Feature comparison: Add Entry itemsets and Repeating Data itemsets
Dynamic child controls
How dynamic controls affect the InForm application
Study design considerations
InForm workflow
Multilingual studies
Locales
How locales are applied in the InForm user interface
Available online Help
InForm user interface
Overview of the InForm user interface
Main user interface window
Components—Main user interface window
Subject search and navigation
Subject search mode
Subject navigation mode
Subject order
Sorting
Email address length
Case Report Books page
Components—Case Report Books page
Time and Events Schedule
Time and Events Schedule—Visit view
Components—Time and Events Schedule Visit view
Visit view—Expand and collapse feature
Visit view—Repeating forms
Time and Events Schedule—Form view
Components—Time and Events Schedule Form view
Time and Events Schedule navigation
CRF pages
Components—Case report form (CRF) pages
Visit navigation—Visit ruler and visit selectors
Form navigation—Form selectors
Page and row selectors
Select Action list
Form indexer
Randomization
CRF item detail pages
Data Value(s) page
Queries detail page
Audit Trail page
Audit trail date/time conversion
Comment page
Itemset Row Comment page
Data Viewer user interface
Types of views in the Data Viewer
Summary View
Components—Summary View
Summary Data Table—Summary View
Locked columns and headers—Summary Data Table
Column sorting—Summary Data Table
Column customization—Summary Data Table
Record Listing View
Components—Record Listing View
Form Data Table—Record Listing View
Locked columns and headers—Form Data Table
Column sorting—Form Data Table
Column customization—Form Data Table
Forms pane—Record Listing View
Summary Data pane—Record Listing View
Detail Pane—Record Listing View
Record Listing Single Subject View
Create custom view dialog box
How the Data Viewer displays dates, visits, and form types
Dates and times
Definition of Expected forms
Expected CRFs and common forms
Expected CRFs and study completion
Record Comparison View
Components—Record Comparison View
Comments View
Components—Comments View
Column sorting—Comments View
Common Data Viewer features
Toolbar—Data Viewer
Filters pane—Data Viewer
Pagination—Data Viewer
Configure Columns dialog box
Column filter dialog box
Icons
Visit and form status icons
CRF status icons
CRF item icons
Query status icons
Signature status icons
Data Viewer module icons
Log in and passwords
Overview of logging in and passwords
Guidelines for choosing a password
Password configuration options
Logging in to the InForm application for the first time
Logging in to the InForm application
Inactive user messages
Reauthentication after a timeout
Changing your password
Setting up your password recovery information
Notification of email address change
Resetting your password
Changing your expired password
Logging out of the InForm application
User interface—Log in and passwords
Login page
Change Expired Password page
Change Password page—For InForm users
Reset Password page
Navigation
Displaying the Case Report Books page
Changing the subject order in the Case Report Books page
Displaying the Time and Events Schedule
Working with CRFs
Displaying a single CRF
Displaying the CRFs for a visit
Using the summary view
Displaying the Data Value(s) page
Displaying the Queries page
Displaying the Audit Trail page
Displaying comments
Navigating between the form views
Navigating between detail pages and forms
Finding a subject by subject number
Navigating among subjects
Navigating through the CRFs in a visit without a mouse
Using the Go controls on the study Home page
Working with the Data Viewer
Displaying the Summary View
Displaying the Record Listing View
Displaying the Record Comparison View
Displaying the Comments View
Navigating from the Data Viewer to a CRF
Navigating from a CRF to the Data Viewer
Navigating from the Data Viewer to the Time and Events Schedule
Navigating from the Time and Events Schedule to the Data Viewer
Screening and enrollment
Overview of screening and enrollment
Screening a candidate
Enrolling a screened candidate
Resubmitting a candidate who failed screening
Reasons for an enrollment failure
Missing enrollment data
Overriding an enrollment failure due to incomplete data
Providing missing data and completing the enrollment
What to do if a candidate does not meet study criteria
Refusing enrollment because the candidate does not meet eligibility criteria
Correcting a data-entry error
Refusing enrollment
Accessing candidate information
Viewing the Screening form for a candidate
Viewing the Enrollment form for a candidate
User interface—Screening and enrollment
Screening Log
Screening form
Enrollment form
Visit calculator (subject schedule)
Forms, comments, and visits
Overview of forms, comments, and visits
Entering form data and comments
Entering form data
Complete data is unavailable
What to do if an item is not editable or visible
What to do if you find a data-entry error after submitting
Marking an item as skipped (an item is not applicable, unknown, or not done)
Marking a form as skipped (a form is not applicable, unknown, or not done)
Attributes of an automatically-generated query
Entering a comment on a form
Entering a comment on a form item
Entering row comments in a Repeating Data itemset
Creating an association between two forms
Updating form data
About updating form data
About updating a form item on the Data Value(s) page
Clearing data
Implications of clearing data
Clearing data from an item
Clearing data from a form
Deleting or undeleting an Add Entry itemset
Deleting an Add Entry itemset before submission
Deleting an Add Entry itemset after submission
Undeleting an Add Entry itemset
Changing form data
What to do if a new data item value results in a query
Reviewing the audit trail
Printing a CRF
Adding an unscheduled visit for a subject
Queries
Overview of queries
Query types
Query states
About working with queries
Query—Data Value section
Query—Action section
Query workflow—For a site user
Query workflow—For a sponsor
Query—Update Data and Answer
Query descriptions
Viewing the list of queries
Viewing the queries for a specific form item
Navigating between queries and CRFs
Issuing queries
Issuing a query
Appearance of items with opened queries
Appearance of items with candidate queries
Changing a candidate query to an opened query
Deleting a candidate query
Answering queries
Answering a query by changing the data value
What to do if the new data value results in another query
Answering a query by submitting answer text
Reissuing a query
Closing queries
Appearance of items with answered queries
Finding answered queries from the Query Listing page
Finding answered queries from the Case Report Books page
Closing an answered query
Working with multiple queries
Closing or reissuing a set of answered queries
Opening or deleting a set of candidate queries
Closing a set of opened queries
Hidden queries
Understanding query conflicts
User interface—Queries
Query Listing page
Queries page
Source verification
Overview of source verification
Partial source verification (Partial SV)
Partial SV terminology
Partial SV and items marked as SV Required during study design
Subjects and the SV Pool
Automatically selected subjects
Manually selected subjects
Imported subjects
Excluded subjects
Critical forms
Considerations for selecting critical forms
Forms not selected for SV
Critical items
When item-level source verification takes effect
Critical items—Effective SV states
About the Critical All Forms Effective SV state
Criticality and override settings
Form criticality overrides
Item or itemset criticality overrides
Checklist—Criteria for configuring Partial SV
Configuring Partial SV
How Partial SV affects InForm features
SV status icons and Partial SV
Subject transfers and Partial SV
Audit trail and Partial SV
Locked forms and Partial SV
Study version and in-place revision changes and Partial SV
Add or remove item from a form—For study version and in-place revision changes
Add or remove a form—For study version changes only
Source verification states
Verified form state
Viewing the source verification listing
Marking a form SV Ready or Not SV Ready
Online source verification
About accessing the source verification view of a form
Public and custom source verification status filters
Selecting a public filter
Creating a custom filter
Saving an applied custom filter
Deleting a custom filter
Accessing the form from the Source Verification Listing page
Filtering the Source Verification listing
Accessing the form from a case report book
About filtering the Time and Events Schedule for Source Verification status
Filtering the Time and Events Schedule for Source Verification status
Source verifying data on an online form
Offline source verification
Source verifying data from a printed listing
Printing an SV Report for offline verification
Displaying the Site Visit Report
How a form change affects source verification
User interface—Source verification
Source Verification Listing page
Set SV settings dialog box
Set SV settings—Override settings dialog box
Set SV settings—Audit History dialog box
Set SV settings—Import subjects dialog box
Source Verification Reports page
SV Report Print Preview page
Site Visit Reports page
Visit Report for Site page
Regulatory Document Checklists page—Site list
Regulatory Documentation Checklist for a Site page
Freezing and locking
Overview of freezing and locking
Rules for freezing and locking
The freezing and locking icons
Freezing or locking a form
Freezing or locking several forms at one time
Freezing or locking all forms in a visit
Performing one freezing or locking action on several instances of a form
Freezing or locking while monitoring
Freezing or locking a case report book
Data changes after freezing or locking
Data Viewer tasks
Customizing the Data Viewer workspace
Overview of customizing the Data Viewer workspace
Filtering data for all views in the Data Viewer
Saving a filter
Modifying a saved filter
Loading a saved filter
Deleting a saved filter
Filtering data on clinical values for the current view
Sorting data in the Data Viewer
Customizing the columns in the Data Viewer
Resizing a column
Reordering column positions
Hiding or unhiding columns
Setting the column names
Maximizing the Data Viewer workspace
Showing the codes or code labels
Showing the entered or normalized values
Reviewing summary data for started and expected forms
Reviewing summary data for a set of visits
Reviewing summary data for a set of sites
Reviewing form data for started and expected forms
Reviewing a single form for a single subject
Reviewing a single form across subjects, visits, or sites
Viewing the details for a form
Comparing data
Comparing two clinical forms
Reviewing comments
Reviewing comments across a single form and one or more subjects, visits, or sites
Reviewing comments across all forms
Marking comments as reviewed
Working with custom Data Viewer views
Overview of creating custom views
Repeating visits and custom views
Repeating forms and custom views
Itemsets and custom views
Creating a custom view
Displaying a custom view
Deleting a custom view created with non-repeating forms and no itemsets
Deleting a custom view created with regular forms, repeating forms, or itemsets
Performing InForm actions
Overview of performing InForm actions
InForm actions available in the Data Viewer
InForm states used in the Data Viewer
Custom review states in the Data Viewer
Custom review states and the audit trail
Creating a query in the Data Viewer
Answering a query in the Data Viewer
Closing a query in the Data Viewer
Freezing and unfreezing records in the Data Viewer
Locking and unlocking records in the Data Viewer
Marking records Verified or Not Verified in the Data Viewer
Assigning a custom review state
Adding item or form comments in the Data Viewer
Exporting data to Excel
Overview of exporting data to Excel
Exporting data to Excel
Exporting comments to Excel
Signatures
Overview of signatures
Form and case report book signatures
List of required signatures
Signature groups
Invalidation of signature by data update
Before you sign a CRF or case report book
Signing a CRF or case report book
When a form changes after signature
When your signature fails processing
Viewing signature status
Viewing the signatures status for your signatures
Viewing the signature status for all signatures
Viewing signature details
Viewing a print preview for a CRF or case report book
User interface—Signatures
Required Signatures page
Study-specific documentation
Overview of study-specific documentation
Viewing study-specific documentation
Displaying study-specific help for a form
Viewing the visit calculator (subject schedule)
Viewing the sample case report book
Subject transfer data
Overview of subject transfer data
Viewing the list of transferred subjects
Viewing a subject transfer archive
User interface—Subject transfer data
Transferred Subjects for Site page
InForm Portal application
Overview of the InForm Portal application
Viewing the InForm Portal application
Loading a company logo
Managing the InForm Portal Home page
Setting the Home page for a user
Updating the Home page with an HTML file
Working with tabs and sections
Creating and naming a tab
Renaming a tab
Reordering tabs
Adding a section to a tab
Editing section properties
Activating or deactivating a tab
Tab types and InForm Portal pages
Managing documents
Before uploading a document
Uploading a document
Updating a document
Editing document properties
Making a document invisible
Restricting document access to sponsor users
Document audit trails
Setting up key contacts
Automated deployment
Overview of automated deployment
Maintenance mode
Deployment log file
Scheduling or running a deployment from the InForm user interface
Canceling a scheduled deployment
Viewing the deployment log
Saving the deployment log
Deleting the deployment log
User interface—Automated deployment
Deployment page
Deployment Log dialog box
InForm administration
Overview of InForm administration
InForm administration pages and locales
InForm administration tasks
System settings
Overview of system settings
Setting the system configuration options
Loading a study logo
Stopping and restarting an InForm study
Viewing system information
User interface—System settings
System Configuration page
Update Study Logo page
System Information page
Rights and rights groups
Overview of rights and rights groups
Rights required for typical study activities
System administration rights
CRF rights
Case report book rights
Query rights
Rule rights
Navigation rights
Miscellaneous user rights
Data Viewer rights
InForm Portal rights
Study deployment rights
Viewing the list of rights groups
Creating a rights group and assigning its rights
Viewing or modifying the rights in a rights group
Viewing or modifying the users in a rights group
User interface—Rights and right groups
Rights Groups page
Rights Groups detail page
Change Members in Rights Group page
Groups and item groups
Overview of groups and item groups
Group types
Item groups
Viewing the list of groups
Creating a group or item group
Viewing or modifying the users in a group
Viewing or modifying the items in an item group
Viewing or modifying the details for a group or item group
User interface—Groups
Groups page
Edit Group Properties page
Change Membership of Group page
Change Membership of Item Group page
Display overrides
Overview of display overrides
User rights for display overrides
Defining rights group display overrides
Item definition display overrides from the Central Designer application
Assigning display overrides to rights groups
User interface—Display overrides
Change Display Override in Rights Group page
Rules
Overview of rules
Rules and events
Types of InForm rules
Browser and server rules
Rules contexts
Types of InForm rule contexts
Rule dependencies
Planning considerations—Rule dependencies
Rule implementation tools
Batch run rules
Frozen and locked case report books and batch run rules
Frozen and locked forms and batch run calculation rules
The audit trail and batch run rules
Implementing and deploying a rule
Viewing the list of rules
Viewing or modifying a rule
Running rules in batch mode
Viewing the status of batch run rules
Viewing the details of batch run rules
User interface—Rules
Rules page
Batch Run Rules Status page
Subject-Rules Status page
Rules detail page
Select Rules to Run page
Rules Selected for Running page
Events
Overview of events
Viewing the list of events
Viewing or modifying the details for an event
User interface—Events
Events page
Events detail page
Sites
Overview of sites
Viewing the list of sites
Creating a site
Viewing or modifying the members in a site (Changing site associations)
Viewing the list of subjects at a site
Viewing or modifying site information
User interface—Sites
Sites page
Sites detail page
Change Members in Site page
Users
Overview of users
Viewing the list of users
Creating a user
Assigning a password to a user
Activating or deactivating a user
Activating or deactivating a user—From the Users page
Activating or deactivating a user—From the User details page
Assigning or modifying a user association to a rights group, site, and other groups
Viewing or modifying the details for a user
Terminating or reinstating a user
User interface—Users
Users page
User details page
Change Password page—For administrators
Subject transfers
Overview of subject transfers
Who can transfer subjects?
Audit history and subject record transfer archive
Contents of a subject transfer archive
Deleted items
Repeating forms
Subject record transfer flow
Subject status and record transfer
Transferring a subject
Subject initials and DOB conflicts
Subject number conflicts
Number conflicts when transferring subjects with the InForm user interface
Number conflicts when transferring subjects with the InForm Data Import utility
Changing a subject number
Subject transfer and study version
Study version considerations when transferring subjects with the InForm user interface
Study version considerations when transferring subjects with the InForm Data Import utility
Resubmitting a subject transfer
Viewing the audit trail for a transferred subject
User interface—Subject transfers
Subject List for Site page
Subject Record Transfer page
Subject Transfer Status page
Site Audit Trail By Subject page
Data Viewer review states
Defining the Data Viewer custom review states
Introduction to Reporting and Analysis
About report data
The Reporting and Analysis database
Basic relational database concepts
Reporting and Analysis terminology
Data models
Data model security
Packages
InForm Trial Management package
Study-specific clinical package
Locales in the Reporting and Analysis module
Reporting basics and options
Reporting and Analysis portal
Report folders
Report output icons
Portal icons
Portal tools
Renewing your credentials
Personal pages
New Page wizard
Report options
Report options for ad hoc reports
Report options for standard reports
Run with options for ad hoc and standard reports
Run with advanced options for ad hoc and standard reports
Report types
Ad hoc reports
InForm standard reports
Custom reports
Comparison of report types
Scheduling reports
Scheduling a single report
Scheduling multiple reports
New Job wizard
Run with options page for an existing job
Set Properties page for an existing job
Comments in saved reports
Enabling comments in a saved report
Adding a comment to a report
Study design considerations
Subject status requirements
DOV controls
Labels for clinical report elements
Optional study elements
Reserved words for Reporting and Analysis
Configuring computer settings for Reporting and Analysis
Browser settings for Internet Explorer
Browser settings for Firefox
Windows Explorer settings
InForm Ad Hoc Reporting
About InForm Ad Hoc Reporting
InForm to Cognos naming correspondence
Accessing the InForm Ad Hoc Reporting workspace
InForm Ad Hoc Reporting workspace
InForm Ad Hoc Reporting tree
InForm Ad Hoc Reporting menu
Running and saving ad hoc reports
Using the InForm Ad Hoc Reporting tree to create reports
Running an ad hoc report from the InForm Ad Hoc Reporting workspace
Running an ad hoc report in a new window
Saving an ad hoc report
Previewing report output with limited or no data
Preview formats
Using the design-time report viewer
Using the run-time report viewer
Opening an ad hoc report in Report Studio
Editing data in an ad hoc report
Opening an existing report
Editing tools in the InForm Ad Hoc Reporting workspace
Using predefined filters
Filter definitions
Adding a filter
Adding a filter without adding a column
Removing a filter
Combining filters
Sorting the elements in a report
Sorting data without adding a column
Summarization
Adding summary data to a report
Configuring automatic summarization settings
Configuring drill up, drill, down, and drill through settings
Lineage information for data
Changing the display format for report elements
Renaming titles and headings
Changing the page layout for a report
Suppressed and deleted data in reports
Internal IDs
About internal IDs
Internal IDs in the Clinical Data by Form folder
Internal IDs in the Trial Management data model
Calculations and conversion rules
About calculations and conversion rules
Calculations on date time elements
Creating a calculation
Dates with unknown date parts
Calculations on string elements
Calculations on numeric elements
Calculating business days versus number of days
Crosstab reports
About crosstab reports
Crosstab development tools
Charts
About charts
Types of charts
Chart configurations
Choosing a chart type
Chart development tools
Custom groups
About custom groups
Defining a custom group
Custom groups on date time elements
Custom groups on numeric elements
Custom groups on string elements
Reporting on study management data
Study management report elements
InForm Trial Management reporting tree
Element descriptions
Study Info report elements
Study Info: Sponsor
Study Info: Study
Study Info: Study Versions
Sites report elements
Sites
Subject report elements
Subjects
Subjects: Subject Status (text)
Subjects: Subject Status Counts
Subjects: CRB Status Counts
Subjects: Subject Status Dates
Subjects: Subject Status by Month and Year
Visit report elements
Visits
Visits: Visit Properties
Visits: Visit Counts by Property
Visits: Visit Status Counts
Visits: Visit Dates
Forms report elements
Form elements and expected forms
Forms
Forms: Properties
Forms: Form Counts by Property
Forms: Form Status Counts
Forms: Review States
Forms: Review States Counts
Forms: Form Dates
Forms: Form Status by Month and Year
Forms: Aging
Forms: Cycle Times
Section report elements
Sections
Sections: Properties
Item report elements
Items
Items: Item Properties
Items: Item Counts by Property
Items: Item Status Counts
Items: Item Dates
Rule report elements
Rules
Query report elements
Queries
Queries: Properties
Queries: Query Counts
Queries: Query Dates
Queries: Query Status by Month, Year
Queries: Cycle Times
Queries: Aging
Comment report elements
Comments
User Info report elements
User Info: Users
User Info: Group Associations
User Info: Historical User Info
Predefined filters
Filters
Reporting on clinical data
Clinical data reports
Reporting on clinical data
Clinical reporting tree
Clinical reporting elements
Creating reports with both clinical and study management data
Clinical data in the InForm Ad Hoc Reporting tree
Default labeling
Clinical report elements: forms and itemsets
Code report elements
Data that require units of measure
Itemsets, repeating visits, and repeating forms
Deleted itemset and form instances
Date controls
Incomplete Data Reasons
Reference information for report elements
Reporting on multi-instance forms and visits
About multi-instance forms and visits
Filtering reports with more than one multi-instance form or itemset
Reporting on forms with itemsets
Example 1: One non-repeating section and one itemset
Example 2: Incomplete non-repeating section and one itemset
Example 3: Incomplete non-repeating section, one itemset, and an additional form
Example 4: One non-repeating section with multiple itemsets
Example 5: Incomplete non-repeating section with multiple itemsets
Reporting on associated forms
Example: Adverse Events and Concomitant Medications association
InForm standard reports
Standard reports
InForm standard reports by category
Running and saving standard reports
Running a standard report from the Reporting and Analysis portal
Running a standard report in a new window
Saving a standard report definition
Saving a standard report as a report view
Opening a standard report in the Report Studio application
Components of a standard report
Report prompt page
Selection Criteria section
Cascading prompts
Checkboxes
Drop-down lists
Text boxes
Calendars
List boxes
Sort Options section
Buttons
Summary page
Report/Graph page
Show/hide report selections
Graphs and columns
Report header and footer
Data in standard reports
Report folders
Report actions
Query reports
Outstanding Queries by Site and Visit
Selection criteria: Outstanding Queries by Site and Visit
Report/Graph page: Outstanding Queries by Site and Visit
Query Aging by Site
Selection criteria: Query Aging by Site
Report/Graph page: Query Aging by Site
Query Cycle Times by Site
Selection criteria: Query Cycle Times by Site
Report/Graph page: Query Cycle Times by Site
Query Cycle Times by User
Selection criteria: Query Cycle Times by User
Report/Graph page: Query Cycle Times by User
Query Performance Summary by Site
Selection criteria: Query Performance Summary by Site
Report/Graph page: Query Performance Summary by Site
Query Performance Summary by User
Selection criteria: Query Performance Summary by User
Report/Graph page: Query Performance Summary by User
Query Status by Site
Selection criteria: Query Status by Site
Report/Graph page: Query Status by Site
Query Status by Site and Subject
Selection criteria: Query Status by Site and Subject
Report/Graph page: Query Status by Site and Subject
Query Status by Site and Visit
Selection criteria: Query Status by Site and Visit
Report/Graph page: Query Status by Site and Visit
Query Status by User
Selection criteria: Query Status by User
Report/Graph page: Query Status by User
Query Volume by Month by Site
Selection criteria: Query Volume by Month by Site
Report/Graph page: Query Volume by Month by Site
Query Volume by Rule
Selection criteria: Query Volume by Rule
Report/Graph page: Query Volume by Rule
Subject Counts with Outstanding Queries
Selection criteria: Subject Counts with Outstanding Queries
Report/Graph page: Subject Counts with Outstanding Queries
Case Report Form (CRF) reports
CRF Aging by Site report
Selection criteria: CRF Aging by Site
Report/Graph page: CRF Aging by Site
CRF Cycle Time Detail by Site
Selection criteria: CRF Cycle Time Detail by Site
Report/Graph page: CRF Cycle Time Detail by Site
CRF Cycle Time Detail for a Site
Selection criteria: CRF Cycle Time Detail for a Site
Report/Graph page: CRF Cycle Time Detail for a Site
CRF Site Performance Summary by Site
Selection criteria: CRF Site Performance Summary by Site
Report/Graph page: CRF Site Performance Summary by Site
CRF Status Detail by Site and Subject
Selection criteria: CRF Status Detail by Site and Subject
Report/Graph page: CRF Status Detail by Site and Subject
CRF Status Detail by Visit and Site
Selection criteria: CRF Status Detail by Visit and Site report
Report/Graph page: CRF Status Detail by Visit and Site
CRF Status Summary by Site
Selection criteria: CRF Status Summary by Site
Report/Graph page: CRF Status Summary by Site
CRF Status Summary by User
Selection criteria: CRF Status Summary by User
Report/Graph page: CRF Status Summary by User
Item reports
CRF Item Listing
Selection criteria: CRF Item Listing
Report/Graph page: CRF Item Listing
Source Verification Listing
Selection criteria: Source Verification Listing
Report/Graph page: Source Verification Listing
Subject reports
Case Book Completion and Query Summary by Site
Selection criteria: Case Book Completion and Query Summary by Site
Report/Graph page: Case Book Completion and Query Summary by Site
Cumulative Subject Enrollment by Month
Selection criteria: Cumulative Subject Enrollment by Month
Report/Graph page: Cumulative Subject Enrollment by Month
Subject Dropout Count by Reason
Selection criteria: Subject Dropout Count by Reason
Report/Graph page: Subject Dropout Count by Reason
Subject Enrollment Status by Site
Selection criteria: Subject Enrollment Status by Site
Report/Graph page: Subject Enrollment Status by Site
Audit Trail reports
Audit Trail Report
Selection criteria: Audit Trail Report
Report/Graph page: Audit Trail Report
Historical Login Report
Selection criteria: Historical Login Report
Report/Graph page: Historical Login Report
Glossary
Ad Hoc Reporting
adverse event (AE)
alternate form
answered query
associated forms
association
audit trail
automatic query
candidate
candidate query
case report book (CRB)
case report form (CRF)
CDD mapping
clinical data
clinical data manager (CDM)
clinical project manager
clinical reporting package
clinical research associate (CRA)
clinical research coordinator (CRC)
closed query
common form
complete form
complete visit
control path
customer-defined database (CDD)
data model
Data Viewer
display override
dynamic control
dynamic form
dynamic visit
enrollment override
event
exclusion criteria
expected form
form
freezing
Home page
inclusion criteria
InForm Reporting and Analysis module
InForm Trial Management package
instance
item
item blinding
item group
itemset
locking
manual query
medical monitor
MedML
opened query
package
partial SV
principal investigator (PI)
product locale
protocol
query
query group
randomization
RefName
regular form
repeating form
repeating visit
reporting group
review schema locale
review stage
review state
right
rights group
rule
screening log
serious adverse event
signature
signature group
site user
source verification
sponsor user
standard report
started form
started visit
study
study data locale
study locale
study-specific clinical model
study-specific documentation
subject
subject registration
SV Report
Time and Events schedule
unscheduled visit
user name
verified
visit
visit calculator
Legal notices
Index