Contents
 Central Designer 2.0 InForm Design Guide
 About this guide
 Overview of this guide
 Prerequisites
 Users
 Related information
 Documentation
 If you need assistance
 Setting up and administering a study
 Creating a study
 Choosing the phase of a study
 Choosing a sponsor for a study
 Editing the properties of a study
 Setting the primary layout for a study
 Selecting locales
 Choosing the supported locales for a study
 About choosing the default locale for a study
 Choosing the default locale for a study
 How to develop a study across multiple locales
 Acceptable formatting for float values
 Saving a study or library project
 Deleting a study or project
 Selecting supported libraries
 Choosing the libraries to use for a study
 Setting the order of libraries in the Libraries list for a study
 Setting up study teams
 Users Browser searches
 Finding and adding a user to a study team and saving the search
 Saving a search in the Users Browser
 Opening a search saved in the repository
 Clearing search parameters
 Closing an active search
 Deleting a search from the repository
 Removing a user from a study or library team
 References
 Attaching a reference to a study
 Removing a reference from a study
 Coding administration
 Administering coding tasks
 Creating, modifying, and deleting a coding map
 Selecting and removing dictionary types for a study or library
 Associating dictionary types with verbatim types for a study or library
 About coding setup activities in the Central Designer application
 Coding terms and definitions
 Coding maps
 Dictionary types
 Verbatim types
 Verbatims, context items, target items, and query target items
 Setting up InForm review states
 About review states
 Creating, modifying, and deleting a review state
 Designing the study workflow
 About study objects in the study workflow
 Creating and editing study objects in the study workflow
 Working with workflow diagrams
 About study workflows
 Workflow diagram components
 Viewing a workflow diagram
 Creating a study object in a workflow diagram
 Connecting and ordering study objects in a workflow diagram
 Changing the sequence number of a study object in a workflow diagram
 Creating a reference copy of a study object in a workflow diagram
 Viewing scheduling information
 Working in the Workflow Grid tab
 Working with study objects in a workflow grid
 Creating a study object in a workflow grid
 Opening a child study object from a workflow grid
 Study workflows and deployment to the InForm application
 InForm visits and forms
 Order of InForm visits and forms
 Dynamic status of InForm visits and forms
 Scheduling of InForm visits
 Deploying to the InForm application
 Sequence numbers
 Invalid workflows
 Working in the Schedule of Events tab
 Using the Schedule of Events tab to update the study workflow
 Adding or removing a form in the Schedule of Events
 Deleting a form from the Schedule of Events
 Editing a form in the Schedule of Events
 Designing forms
 Forms design activities
 About forms
 Creating and editing a form
 Making a form common or not common
 Making a form or section repeating or nonrepeating
 Marking a form for source verification
 Marking a form as a special InForm form
 Associating two forms
 Choosing form layouts for a study or library
 Creating and translating instructions and Help for a form
 Viewing the parents of a linked form
 Special InForm forms and items
 Screening form
 Enrollment form
 Patient Identification form
 Study Completion form
 Date of Visit item
 Randomization item
 Deciding whether to create custom special InForm forms or use the default forms
 Validation for special InForm forms and items
 Custom properties for special InForm forms and items
 Non-clinical forms
 Creating a regulatory document form
 Creating a visit report form
 Validation for monitoring forms
 Designing sections
 About sections
 Creating and editing a section
 Reordering the sections on a form
 Creating and translating instructions and Help for a section
 Viewing the parents of a linked section
 Designing fixed repeating sections
 About fixed repeating sections
 About writing rules for fixed repeating sections
 Creating and editing a fixed repeating section
 Items and codelists
 About items
 Conditional relationships between items
 About codelists and codelist items
 Items and units
 Creating and editing an item
 Adding a child item to a compound item
 Reordering an item in a form or section
 Specifying column heading text for an item in a repeating form or section
 Reserved words for an item short question
 About key items in a repeating form or section
 Key items for navigating to an instance of a repeating form
 Unique keys
 Key item requirements
 Creating keys in a repeating form or section
 Creating and editing a codelist
 Creating and editing a codelist item
 Designing rules
 About rules
 About data-entry rules
 Intrinsic rules
 Constraint rules
 Calculation rules
 When to use intrinsic rules, expression rules, and functions
 Rule collaboration
 Disabled rules
 Rules tab
 Rule design considerations
 Rule scope
 Rules and calculated fields
 About overriding Screening and Enrollment failures
 Rules with multiple actions
 Rules on repeating study objects
 About copying and moving data-entry rules
 About locking data-entry rules, workflow rules, and global conditions
 About workflow rules and global conditions
 Workflow rules
 Global conditions
 Deciding between a workflow rule and a global condition
 About the rule expression language
 Dynamic prompts in the Expression workspace
 Selecting a rule model object from a dynamic expression prompt
 Designing data-entry rules
 Creating an intrinsic rule
 Creating a rule without a function
 Creating a rule using a function
 Modifying a rule
 Translating query and email information for rules
 Viewing all rules for a study object and its children
 Selecting multiple rules
 Deactivating a rule
 Disabling one or more rules
 Enabling one or more disabled rules
 Designing workflow rules
 Creating a workflow rule in a workflow diagram
 Editing a workflow rule in a workflow diagram
 Updating the state of a workflow rule
 Designing global conditions
 Creating a global condition
 Assigning and removing a global condition
 Viewing and editing a global condition
 Testing rules
 About test cases
 Opening the Rule Test Cases dialog box
 Viewing rules in the Rule Test Cases dialog box
 Opening a rule from the Rule Test Cases dialog box
 Checking rule syntax
 Viewing the errors for a rule
 Checking syntax for one or more rules or global conditions
 Writing a test case for a rule or global condition
 Selecting values for an item on a repeating study object
 Running test cases and viewing the results
 Addressing rule compilation errors
 Filtering the rules that appear in the Rule Test Cases dialog box
 Finding a rule
 Deleting and renaming filters in the Rule Test Cases dialog box
 Deleting a test case
 Saving test cases
 Designing data mappings
 About data mappings, data sets, and data series
 About data mappings
 Creating a data mapping
 Persistence of data mappings
 Different ways to set up data mappings
 About adding and mapping items to data series
 About mapping data values to data mappings
 About copying study objects grouped by data mappings
 Example—Creating a data mapping to create an SDTM model
 Data mappings for data extraction
 About using CDD and CIS data mapping definitions
 Data mappings for rule creation
 Data sets
 Creating a data set
 Standard and custom data dimensions
 Example—Standard and custom data dimensions
 Data series
 Creating a data series
 Data types for data series
 Adding an item to a data series
 Removing an item from a data series
 Unmapping and restoring an item mapping with a data series
 Opening an item from the Data Series Editor
 Changing the data value that is associated with a data series
 Validation for data mappings
 Rule data mappings
 About rule data mappings
 Deciding when to use a data mapping and when to move a rule to a higher-level study object
 Data mappings and the rule engine
 Example of data mappings for rule creation
 Modifying labels of mapped custom data dimensions
 Deleting a custom data dimension
 Mappings and the Data Mappings tab
 Data mapping setup for referencing specific instances of an item
 Data series mapping options and the Data Mappings tab
 Standard data dimensions and data set methods on the Data Mappings tab
 Study object nodes in the Data Mappings tab
 CDD data mappings
 About CDD mappings
 Example—Creating a CDD mapping
 How data mappings are deployed to CDD tables
 Mapping associated forms to a CDD
 Target keys in CDD data mappings
 Target key types for tables that do not pivot
 Target key types for pivot tables
 Setting up a pivot table with CDD data mappings
 CDD data mappings for date time items
 Modifying CDD date time part data mappings
 CDD data mapping setup for date time items
 CIS data mappings
 How data mappings are deployed to Clintrial study objects
 CIS data mappings and Clintrial subsets
 About Clintrial subsets
 Subset keys and subset values in the Central Designer application
 Setting up data mappings for a Clintrial subset
 Block keys and page keys in CIS data mappings
 How block key values are assigned
 How page key values are assigned
 CIS data mappings for specialized Clintrial panels
 Creating a custom Clintrial context panel
 Creating a Clintrial enrollment panel
 Creating a non-patient data (Type 0) panel
 MedML definition of the default context panel
 Design considerations for a custom context panel
 CIS data mappings for date time items
 CIS data mapping setup for date time items
 Modifying CIS date time part data mappings
 CIS data mappings for unmapped items and no items in a data series
 Formatting layouts
 About layouts and the Layout tab
 About styles and inheritance
 Editing the appearance of layouts using study, form, and control styles
 Adding and removing names for layouts
 Restricting the text that an InForm user can type in a text field
 Removing a layout
 Resetting a layout
 Renaming a layout
 Undoing and redoing an action in a layout
 Converting layouts
 About layout design
 Creating a layout for a form or item
 Ease of use and navigation in the Layout tab
 About creating site-specific layouts
 Form previews
 Annotated form previews
 Choosing the default view for a fixed repeating section
 Supported HTML formatting tags
 Generating and printing a preview or annotated preview of a form
 Formatting questions and controls
 Editing and translating a question
 Creating, editing, translating, and removing a section note
 Showing and hiding a section header
 Editing and translating a form or section title
 Working with captions
 Editing and translating a codelist item label override
 Editing the size of a text box
 Editing the width of the question column
 Formatting codelist items and items with units
 Changing the orientation of a group control
 Specifying the year range for a date time item
 Marking an item as hidden or read-only
 Translating text
 Where to enter translated text
 Examples of data that cannot be translated
 Creating and translating instructions and Help for a study design
 Entering and translating the title and short title of the Common Visit
 Translating the short title of a study event
 Translating the short title of a form
 Translating the question text of an item
 Translating a codelist item label
 Translating text in the Layout tab
 Viewing locale-specific translations in a layout
 Validating and deploying a study
 About study validation and deployment
 Validation and deployment definitions
 Validation and deployment workflow summary
 Upgrade considerations
 Validating a workflow or study
 Validating a workflow
 Validating a study and creating a baseline
 Saving validation messages to a CSV file
 Disabling a workflow
 Baseline
 Validating a study and creating a baseline
 Viewing baseline validation errors and warnings
 Ignoring and resolving baseline validation errors and warnings
 Editing a validation baseline description
 Deleting a validation baseline
 Making a validation baseline public
 Checks performed during validation
 General validation checks
 Validation checks for InForm deployment
 Validation for coding
 Information not validated
 Deployment
 Deployment package processing in the InForm application
 Central Designer and InForm study component correspondences
 Creating a deployment package
 About deployment packages
 Delivering a deployment package
 Saving the job log to a CSV file
 Deleting a deployment package
 Creating a deployment package
 Deployment Editor
 About installing a deployment package
 Installing a deployment package using the Deployment Wizard
 Installing a deployment package using command-line options
 Executing the deployment package
 Deployment command-line options
 Deployment ConfigFile options
 Sample deployment configuration file
 Performing post-design activities
 Protecting and unprotecting study objects
 About protecting study objects
 Protecting and unprotecting a study or study object
 Protecting and unprotecting a library
 Archiving and decommissioning a study
 About decommissioning studies and projects
 Workflow for decommissioning studies and projects
 About archiving
 About deleting a study or project
 About downloading and importing an archive
 Information that is archived
 Information that is deleted when you delete a study or project
 Information that is imported from an archive
 Decommissioning
 Archiving a study or project
 Viewing archived studies and projects
 Deleting a study or project
 Downloading and importing an archived study or project
 Deleting an archived study or project from the database
 Viewing errors associated with an archive
 Generating reports
 About reports
 Generating, saving, and printing a report
 Data Entry Rule Actions report
 InForm RefName report
 Library Objects Modified in the Study report
 Library Objects Modified in the Library report
 Number of Studies Containing Library Objects report
 Library Objects Modified in Studies report
 Studies Containing Selected Library Object report
 Generating an Annotated Study Book
 About Annotated Study Books
 Annotated study books, locales, and layouts
 Annotated Study Book Options dialog box
 RDE Analytics tables in the Annotated Study Book
 RD Column Name in RDE Analytics tables
 Schedule of Events table in the Annotated Study Book
 Generating an Annotated Study Book
 Printing an annotated study book
 Creating a PDF file for an annotated study book
 Tips for printing an annotated study book or creating a PDF file
 Formatting dates on the Annotated Study Book for the Japanese locale
 Exporting the Schedule of Events table to a CSV file
 Option and property descriptions
 Annotated Study Book
 Annotated Study Book Options dialog box
 Forms, items, codelists, and codelist items
 Codelists Editor—Option descriptions
 Codelist Items Editor—Option descriptions
 Design tab of the Codelist Editor—Option descriptions
 Design tab of the Form Editor or Section Editor—Option descriptions
 Design tab of the Item Editor—Option descriptions
 Forms and sections editor—Option descriptions
 General tab of the Form Editor or Section Editor—Option descriptions
 InForm Items Editor—Option descriptions
 Item Properties dialog box—Option descriptions
 Keys dialog box
 Languages tab of the Codelist Item Editor—Option descriptions
 Data mappings
 Custom Dimension Labels - Select Codelist dialog box—Option descriptions
 Data Series Editor—Field descriptions
 Data Series Properties dialog box—Option descriptions
 Data Series Summary tab—Option descriptions
 Data Set Editor—Field descriptions
 Data Set Properties dialog box—Field descriptions
 Date-Time Data Point dialog box—Option descriptions
 Item has units dialog box—Option descriptions
 Mapping Editor—Field descriptions
 Select Custom Dimension dialog box—Option descriptions
 Layouts
 Control Styles dialog box—Option descriptions
 Layout tab options and deployment to the InForm application
 Study Level Styles and Form Level Styles dialog boxes—Option descriptions
 Rules
 Assign Conditions dialog box—Option descriptions
 Define Test Values for Repeating Instances dialog box—Option descriptions
 Design tab of the Rule Test Cases dialog box—Option descriptions
 Edit Global Conditions dialog box—Option descriptions
 Edit Rule Action dialog box—Option descriptions
 Edit Schedule dialog box—Option descriptions
 Edit Schedule and Rule Action dialog box—Option descriptions
 Email Action dialog box—Option descriptions
 Invoke Function dialog box—Option descriptions
 Query Action dialog box—Option descriptions
 New Rule Template dialog box—Option descriptions
 Rule Templates tab—Option descriptions
 Rule Wizard—Option descriptions
 Rules tab—Option descriptions
 Run tab of the Rule Test Cases dialog box—Option descriptions
 Set Review State Action dialog box
 Set Value Action dialog box—Option descriptions
 Workflow Expression Editor dialog box—Option descriptions
 Setting up and administering a study
 Coding tab—Option descriptions
 Coding Map dialog boxes—Option descriptions
 Libraries tab—Section descriptions
 Libraries tab—Button descriptions
 References tab—Option descriptions
 Review State editor—Option descriptions
 Review States editor—Option descriptions
 Study General tab—Option descriptions
 Teams tab—Field descriptions
 Study elements and study events
 Study Elements editor—Option descriptions
 Study Events Editor
 Study workflow
 Common Visit tab of the Study Design Editor—Option descriptions
 General tab of the Study Event Editor—Option descriptions
 Schedule of Events tab—Option descriptions
 Workflow Diagram tab—Option descriptions
 Workflow Grid tab—Option descriptions
 Validation and deployment
 Baselines Browser—Option descriptions
 Create Deployment Package Wizard—Full deployment package
 Create Deployment Package Wizard—Incremental deployment package
 Deployment Editor—Option descriptions
 Deployment Wizard for InForm deployment
 Jobs Browser—Option descriptions
 Properties
 CDD data mapping properties
 CIS data mapping properties
 Codelist properties
 Codelist item properties
 Data mapping properties
 Data series standard properties
 Data set properties
 Form and section properties
 Item properties
 Study and library standard properties
 Study design properties
 Study element properties
 Study event properties
 Study project and library project properties
 Properties in the Rule Test Cases dialog box
 Glossary
 annotated study book
 application role
 arm
 authentication
 authorization
 baseline
 Baselines Browser
 branch
 calculation rule
 catalog
 catalog administration
 category
 CDISC
 checkbox
 clinical project
 clinical protocol
 clinical study
 codelist
 codelist item
 coding
 coding dictionary
 coding map
 coding target
 collaboration
 collaboration note
 collaboration note type
 Collaboration Notes Browser
 common form
 component
 compound item
 constant
 constraint rule
 container
 context item
 CSML
 custom data dimension
 custom property
 data dimension
 data series
 data set
 data type
 data-entry rule
 date time item
 deployment
 dictionary metadata item
 dictionary type
 drop-down list
 dynamic form
 dynamic visit
 edit check
 element
 event
 explicit lock
 expression
 field
 float item
 form
 full installation deployment package
 function
 global condition
 globals
 grouping
 implicit lock
 incremental deployment package
 integer item
 internationalization
 intrinsic rule
 item
 Job Log Browser
 keyword
 Libraries Browser
 library
 Library List
 library project
 library role
 library team
 locale
 localization
 locked
 mapping
 MedML
 method
 normalization
 object
 ODM
 precondition
 project
 Project Explorer
 Properties Browser
 property
 protocol
 publish
 query
 radio button
 reference
 RefName
 repeating form
 repository
 revision
 right
 role
 role administration
 rule
 rule action
 rule scope
 rule template
 rule type
 SDTM
 shared form
 site
 standard data dimension
 standard task type
 study
 study arm
 study book
 study branch
 study design
 study element
 study event
 study object
 study object editor
 study project
 study role
 study team
 study workflow
 subject
 system
 system configuration administration
 target item
 task
 task classification
 task type
 Tasks Browser
 team
 template
 text box
 text item
 translation task type
 type
 unpublish
 user
 user administration
 Users Browser
 validation
 verbatim
 verbatim type
 version
 visit
 workflow
 workflow rule
 workspace
 yes no item
 Legal notices
 Index
|
|