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