annotated study book
A form-by-form summary of the design of a study. Optionally, it includes a time and events schedule, a preview of each form, and selected annotations that list design details.
See also study book.
application role
A role associated with administrative activities.
arm
See study arm.
authentication
The method of ensuring that you are using the correct user name and password to log on.
authorization
The method of giving users access to information or functionality. Access is controlled using rights, roles, and teams.
automated deployment
The process through which a deployment package is sent directly from the Central Designer application to the InForm application and installed without additional action required.
baseline
A snapshot of all components in a study. Validation creates a baseline.
Baselines Browser
A browser in which you view the results of validation and make temporary baselines public so that other users can work with them.
branch
See study branch.
calculation rule
A rule that sets the value of an item based on a calculation.
catalog
A collection of categories and keywords that can be attached to users and study objects to facilitate searching in the Libraries Browser and Users Browser.
catalog administration
The process of creating keywords and categories and assigning them to users and study objects for faster and more sophisticated searching.
category
A hierarchical grouping of keywords. You can create categories only from existing keywords.
CDISC
Clinical Data Interchange Standards Consortium. CDISC is an open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development.
checkbox
A type of data entry control in which you can select one or more options by selecting the box that represents each option.
clinical project
See study project.
clinical protocol
See protocol.
clinical study
See study.
codelist
A collection of code-label pairs that gather together the entry choices for an item. A code-label pair consists of a single code (the value that is used for analysis) and a label (the value that is visible to users).
See also codelist item.
codelist item
A code-label pair consisting of a single code (the value that is used for analysis) and a label (the value that is visible to users). Multiple codelist items make up a codelist.
See also codelist.
coding
The process of selecting terms and codes from a dictionary for a verbatim.
coding dictionary
A standardized collection of terms and the codes that correspond to those terms.
coding map
A study object that contains the necessary information to code an item.
coding target
See target item.
collaboration
The process by which users with different roles and specialties can work together to create, validate, and deploy a study.
collaboration note
A note that you attach to any study object.
collaboration note type
A classification used to identify the type and purpose of a collaboration note.
Collaboration Notes Browser
A browser in which you work with collaboration notes.
common form
A form that is designed for use with multiple study events. The same data appears in the form in all study events in which the form is used.
component
Any design building block that is configured in a study or library. Design components include study objects (such as a project, study, study element, study event, form, or item) as well as rules, individual items selected from drop-down lists, and controls (such as checkboxes and radio buttons).
compound item
An item that has one or more child items that can have different data types.
constant
A value that is defined in a library or study and that can be referenced by any rule.
constraint rule
A rule that checks whether data is valid. Constraint rules are used to confirm that clinical data meets the requirements of the clinical protocol.
container
A node in the Project Explorer that contains zero or more study objects or components.
context item
An item that provides additional coding information, such as the indication and route of administration for drugs, that can be displayed with an item coded using the WHO-DD dictionary.
CSML
Clinical Study Markup Language. CSML is an XML-based markup language developed by Oracle for representing and exchanging clinical data definitions created in the Central Designer application.
See also MedML.
custom data dimension
See data dimension.
custom property
A user-defined or default characteristic of a study object.
data dimension
A key item for a data set. A data dimension specifies the additional information that will be saved when study data is collected. You can specify standard data dimensions (Study, Subject, Event and Event Index, Form and Form Index, and Item) and custom data dimensions.
data series
A grouping of one or more items with the same clinical meaning, such as one or more items that measure weight.
data set
A grouping of one or more related data series.
See also data series, mapping.
data type
An attribute for items and data series. For an item, the data type determines the type of entry an item will accept. For a data series, the data type determines which items can be added to it. Data types include date time, integer, float, and text.
data-entry rule
A rule that checks whether data is valid or that sets the value of an item based on a calculation.
See also workflow rule.
date time item
An item used to collect date and time information on a form.
deployment
The process of sending a study to a target application. To collect data, a study must be deployed into a target application as a complete deployment package.
deployment approval
The optional process by which a study deployment is approved by a user with the appropriate rights.
deployment instance
The server to which you deploy a study.
deployment request
A request from a user with the appropriate rights to initiate an automated deployment to the InForm application.
dictionary metadata item
An identifier that describes administrative data about a dictionary and that you can use to create a coding map.
dictionary type
A name or identifier for the metadata for a dictionary.
drop-down list
A data entry format in which you select an option from a list.
dynamic form
A form that is automatically generated in the InForm application when subject data satisfies certain criteria tested in another form.
dynamic visit
A visit that is automatically generated in the InForm application when patient data satisfies certain criteria tested in another visit.
edit check
A data-entry rule that checks whether entered data is valid.
See data-entry rule.
element
See study element.
event
See study event.
explicit lock
A lock that you request and that does not expire.
See also implicit lock.
expression
The part of a rule that specifies what to evaluate.
field
The area in a data-entry window where the value for an item is entered or displayed.
float item
An item used to collect numerical values with decimal points.
form
A container for one or more items. A form can contain one or more sections and supports multiple locales and layouts. A form is deployed to a target application as a data-entry form used to collect subject information and other clinical data.
full installation deployment package
A deployment package that contains everything needed to deploy a complete study.
function
A reusable piece of code that extends the behavior of a rule. A function can be predefined or user-defined.
global condition
A logical construct that, when applied to a study object, determines whether the study object will appear for a particular subject. A global condition does not affect other study objects in the workflow.
See also workflow rule.
globals
Study objects and properties that are related to mappings.
grouping
A default or user-provided value used to organize custom properties of a study object.
implicit lock
A type of lock used when you edit a study object. An implicit lock is automatically applied when you select or open a study object and is automatically released when you close or save a study object.
See also explicit lock.
incremental deployment package
A deployment package that contains a complete study based on a previously created deployment package, plus any additions or changes.
in-place revision (IPR)
A study design change that is applied to existing study versions previously deployed to the InForm application.
integer item
An item used to collect a numerical value without a decimal point.
internationalization
The process of configuring a study for translation into different languages or for different regional requirements.
intrinsic rule
A constraint rule or calculation rule based on a predefined rule template.
item
A study object used as a container for the collection of clinical data.
item group
A study object used to combine items so that you can set their display override options in the InForm application.
Job Log Browser
A browser in which you view the results of asynchronous jobs, such as validation or import.
keyword
An identifier that is associated with users and study objects to facilitate more powerful and efficient searches.
Libraries Browser
A browser in which you search the repository for study objects and then add them to studies or libraries.
library
A container used to store related study objects and templates to be published for reuse in studies or other libraries. A library provides a view of the study objects in the repository.
See also repository.
Library List
A hierarchical list of libraries from which resources can be used. The hierarchy determines the order in which libraries are searched. The Library List is defined for each study in the Study Editor.
library project
A project containing a library.
library role
A role associated with library activities.
library team
A group of users who have rights granted by a certain role to perform tasks in a particular library.
locale
A supported language or language variation.
localization
The process of designing a study for a specific locale.
locked
A state in which only the user who created the lock can modify a study object. Locks can be implicit or explicit.
See also implicit lock, explicit lock.
mapping
A data grouping that provides an alternate data view of a study. Mappings were previously called logical schemas.
See also data series, data set.
MedML
An XML-based markup language developed by Oracle for representing and exchanging clinical data definitions created in the InForm application..
See also CSML.
method
A block of code that is called by a rule and that is used to manipulate data.
normalization
The process of converting data to a required format.
object
See study object.
ODM
Operational Data Model. ODM is an XML-based standard developed by the Clinical Data Interchange Standards Consortium (CDISC) for representing and exchanging clinical data.
precondition
The part of a rule that specifies when to evaluate the rule expression.
project
See library project and study project.
Project Explorer
A browser that displays a view of the open project and the study objects it contains.
Properties Browser
A browser in which you can view and modify the properties of the study object selected in the Project Explorer.
property
A defining characteristic of a study object.
protocol
A detailed plan that describes how investigators conduct a study. The clinical protocol sets the guidelines for the study, describes the conditions of the study, and contains a set of forms on which clinical data is collected.
publish
The action that makes a study object created in a library available to other users.
See also unpublish.
query
A text string that appears on a CRF item in the InForm application when a rule on that item fails. When designing a rule in the Central Designer application, you can specify the query text and the circumstances under which a rule results in a query.
query group
A study object used to specify the users who can act on queries created by other members of the group in the InForm application.
radio button
A type of data entry format in which you must select a single item from a list of choices.
reference
A text note, a link to a Web page or file (URL), a document, or a combination of all three, that is attached to a study project for users to consult during the development of a study.
RefName
A unique identifier for a study object.
repeating form
A type of form for which the Repeating property is set to true. You use a repeating form to collect multiple instances of the same data at different dates and times.
repository
A single database instance that contains all Central Designer study objects, components, and users.
revision
An audit history record that is created automatically when a user edits a study object and saves the changes.
right
A predefined permission that controls access to a specific feature or activity in the Central Designer client or Central Designer Administrator client and that can be assigned to one or more roles.
See also role.
rights group
A study object used to create a set of predefined InForm rights in the InForm application.
role
A collection of rights. When a user is assigned to a role, the rights associated with the role are granted to the user.
See also library role, study role, and user role.
role administration
The process of managing tasks that users perform in the Central Designer and Central Designer Administrator applications, assigning rights to roles, and assigning roles to users.
rule
See data-entry rule, workflow rule.
rule action
The action, or actions, that takes place as a result of the evaluation of a rule expression.
rule scope
The set of study objects that a rule can reference. The scope of a rule is determined by the study object on which the rule is defined.
rule template
A function that is defined on a study object, study object template, or study object type and can be used as the expression clause of a rule.
rule type
See calculation rule, constraint rule, and intrinsic rule.
SDTM
Study Data Tabulation Model. SDTM is a CDISC model used to standardize data structures in data extracts.
shared form
See common form.
signature group
A study object used to specify the forms that require signature and the signature type in the InForm application.
site
A location that participates in a study.
sponsor
A study object used to define the sponsor properties of a study, such as name or address, in the InForm application.
standard data dimension
See data dimension.
standard task type
A task type that is typically used for all non-translation tasks assigned to an individual or team.
study
The definition of the workflow, data-entry, and data-management system for a clinical study.
study administration object
A collection of study objects that are used to capture study administration data for deployment to the InForm application.
See also item group, query group, rights group, signature group, sponsor, study configuration.
study arm
The CDISC term for a study branch consisting of a planned sequence of study elements. A study arm is typically equivalent to a treatment group.
study book
The set of forms used to collect clinical data.
See also annotated study book.
study branch
A path for which data is collected for certain subjects. A study can contain multiple branches as different conditions are assessed, and a branch is followed depending on the subject and other circumstances.
study configuration
A study object used to specify the value of an InForm configuration variable in the InForm application.
study design
A container for the structure of a study.
study element
The CDISC term for a basic building block of a study. A study element represents a segment of a study and can consist of one or more study events. Study elements are optional.
study event
A subject evaluation checkpoint when data is collected. Study events usually correspond to visits, but one visit can span multiple study events.
study object
A study building block that appears in the Project Explorer. Study objects include study projects, library projects, studies, libraries, study elements, study events, forms, sections, items, codelists, codelist items, deployment instances, in-place revisions, and study administration objects.
See also component and study administration object.
study object editor
An editor for each study object, such as a project, study, study element, study event, form, or item. A study object editor appears in the workspace when you select a study object.
study project
A project containing one or more studies that are related to each other.
study role
A role associated with study activities.
study team
A group of users who perform tasks granted by a certain role for a particular study.
study workflow
See workflow.
subject
An individual who participates in a clinical study.
system
An application to which you deploy a study from the Central Designer application.
system configuration administration
The process of creating, configuring, and managing internationalization, collaboration, and customization information using the Central Designer Administrator application.
target item
An item that holds a term, code, or additional information after a verbatim is coded.
task
A request that you attach to a study object and assign to an individual or a study team.
task classification
The classification of a task. You can choose either standard (used for all non-translation tasks assigned to an individual or team) or translation (used for tasks that request translation of a study object into one or more languages). You define the classification for task types in the Central Designer Administrator application.
task type
A classification used to identify the type of the task and the way the task is used.
Tasks Browser
A browser in which you work with tasks.
team
See study team, library team.
template
A study object that is either partially or fully defined and that can be used to create other study objects. You can create templates for study projects, studies, study elements, study events, forms, items, codelists, and mappings.
text box
A data-entry format in which you type data.
text item
An item used to collect alphanumeric information.
translation task type
A task type that is used for tasks that request translation of a study object into one or more languages.
type
A study object that is either partially or fully defined and can be used to create other study objects. Types are like templates except that types appear as options in the Actions menu and in the Project Explorer menu when you create a new study object.
unpublish
The action that makes a study object in a library no longer available to other users.
See also publish.
user
A person who works in the Central Designer or Central Designer Administrator application.
user administration
The process of managing users.
user role
A role associated with user activities.
Users Browser
A browser in which you search the repository for users and then add them to study teams or library teams.
validation
The process of checking the status of a study to indicate if the study is ready for deployment. The study validation process determines whether all essential components exist and are consistent.
verbatim
The original reported text that describes the adverse event, disease, drug, or other item to be coded in the Central Coding application.
verbatim type
A classification of a verbatim as defined in a coding dictionary.
version
An explicitly requested audit history record for a study object.
visit
See study event.
workflow
The progression of work for a study, as determined by the study designers.
workflow rule
A logical construct that tests data values to determine the study element, study event, or form to which a subject progresses next. A workflow rule prevents study objects in the workflow from appearing until the rule is evaluated.
See also data-entry rule, global condition.
workspace
The work area of the Central Designer and Central Designer Administrator applications. The contents of the workspace depend on the type of activity you are performing and the rights that you have been granted. The workspace displays the editor for the study object that is selected in the Project Explorer.
yes no item
An item used to collect yes or no answers to questions. A yes no item contains a predefined codelist with Yes and No options.
Copyright © 2013, 2016 Oracle and/or its affiliates. All rights reserved.