Glossary

Ad Hoc Reporting

The Reporting and Analysis module that allows you to create, run, and save customized reports on clinical and study-management data.

adverse event (AE)

An undesirable symptom or occurrence that a subject experiences during or after a study.

Also called adverse experience, adverse drug reaction, side effect. See also serious adverse event.

alternate form

A new version of a form that collects additional data on a subject after the visit in which such data would usually be recorded. The alternate form appears in the visit where the data would have been collected originally.

answered query

The state of a query after a site user has responded to it, and before it has been verified by a sponsor representative.

associated forms

Instances of a repeating form that are linked to each other.

association

The many-to-many relationship that can exist between two repeating forms.

audit trail

A complete record of changes made to study data.

automatic query

A query that the InForm application generates when a submitted data item does not meet certain criteria that is defined by the study designer.

candidate

A person considered for, but not yet accepted into, a study.

candidate query

A preliminary query, issued by a sponsor user, that is visible to sponsor users but not to site users.

case report book (CRB)

The collection of all case report forms (CRFs) for a single study participant.

Also called case book.

case report form (CRF)

A form that is used to record clinical data about an enrolled subject.

Also called case record form. See also form.

CDD mapping

A set of mapping definitions, specifying the data source and target, that enable the transfer of data from a study database to a customer-defined database. Mapping definitions are generated by the Central Designer application.

See also customer-defined database (CDD).

clinical data

The data entered on a CRF or imported into the database that records the interventions and assessments performed on study subjects according to the study's protocol.

clinical data manager (CDM)

A person responsible for preparing and maintaining a study database and reviewing data.

clinical project manager

A person responsible for all aspects of one or more clinical studies or for the entire clinical plan for a drug, device, or procedure.

clinical reporting package

An Ad Hoc Reporting package that provides access to both clinical and study-management data for reporting.

clinical research associate (CRA)

A person who is hired by a sponsor to supervise and monitor the progress of sites that are participating in a study.

Also called monitor, site monitor.

clinical research coordinator (CRC)

An assistant to the investigator at a site.

Also called site coordinator, study coordinator.

closed query

The state of a query after a site user changes an invalid data value to a valid data value, or a sponsor user manually changes the status to closed.

common form

A CRF containing data that is cumulative from visit to visit.

Also called common CRF.

complete form

An expected form that meets the following criteria: it is started and all required items contain data.

complete visit

A visit for which all the expected forms have a current status of complete.

control path

A sequence of IDs that define the physical location of a data point in the InForm database.

customer-defined database (CDD)

An extract of the study database that can be collected as the data is entered.

See also CDD mapping.

data model

A logical representation of the data in the InForm database that describes data objects, structure, grouping, data relationships, and security. Data models are used to create ad hoc reports.

Data Viewer

A standard feature that provides Clinical Data Managers (CDMs) and other InForm users with a real-time overview of clinical study data across visits and sites. The Data Viewer can include custom workflows for tracking the review process.

display override

A property that is applied to a specific item, which overrides default display properties for all users. The display properties can be set to Hidden, Editable (default), or Read-Only.

See also item blinding.

dynamic control

A control that is visible or hidden depending on whether the parent control is selected.

dynamic form

A form that is generated in a study as a direct result of data that you enter. For example, a Pregnancy Result form can be a dynamic form that is generated if the value of a Gender item is Female.

dynamic visit

A visit that is generated in a study as a direct result of clinical data that you enter. For example, if a subject agrees to extend participation in the study, extension visits are automatically generated.

enrollment override

An optional feature you can use to register candidates into a study when they do not meet study criteria.

event

A study component that specifies the action to take when a rule fails.

exclusion criteria

A list of admission criteria, any one of which excludes a candidate from participation in a study.

expected form

A form that meets any of the following criteria: it appears within a scheduled visit (regardless of whether the form is started), it appears within a started unscheduled visit, or it is a dynamic form that has been activated.

form

The data collection mechanism that is used in a study to gather data. The term "form" by itself can be any type of form in the user interface, which includes case report forms, but also several system forms.

See also case report form (CRF).

freezing

An action you perform on a CRF or case report book that prevents site users from entering data, editing existing data, or adding comments. A CRF or case report book that is frozen allows queries and signatures.

See also locking.

Home page

The page that appears when you log in to the InForm application. The Home page can be an HTML page, or a portal created with the InForm Portal application. You can set the Home page at the study, site, or user level.

inclusion criteria

A list of admission criteria that candidates must meet to be eligible for participation in a study.

InForm Reporting and Analysis module

An optional part of the InForm application that provides a library of configurable reports, predefined reports, and ad hoc reporting and charting tools.

InForm Trial Management package

An Ad Hoc Reporting package that provides access to study management data for reporting and allows users to share the reports across studies.

instance

One set of repeating data in an itemset, repeating form, or repeating visit.

item

A non-repeating data point on a CRF.

item blinding

The process of refining user access, which is defined in the Central Designer application, to individual data items on forms by specifying, for a particular rights group, whether the group of items that make up an item group is Hidden, Editable, or Read-Only. The user access is implemented using the display override feature.

See also display override.

item group

A set of items that you group together so that you can assign a display override to it.

See also display override.

itemset

A group of items that repeat on a CRF. You use itemsets for submitting multiple rows of data on a form at one time.

There are two types of itemsets: Add Entry itemsets and Repeating Data itemsets.

locking

An action you perform on a CRF or case report book that prevents all tasks, except for electronic signatures, from being performed.

See also freezing.

manual query

A query that a sponsor user creates and issues during the review process.

medical monitor

A person who designs the study protocol and reviews data.

MedML

The Oracle XML for representing and exchanging clinical data definitions created in the InForm application.

opened query

The original state of a query that is visible to the site and available for response.

package

A grouping of data from one or more data models in the InForm reporting database.

See also data model, InForm Trial Management package, study-specific clinical model.

partial SV

Partial source verification. A standard feature that allows you to control, for each site, the data marked as SV Required during the study design that must be verified for all subjects in the study. Subjects, forms, and items can be configured for partial source verification.

principal investigator (PI)

The clinician who is responsible for treating subjects, executing the protocol of a study at a specific site, and filling out CRFs for subjects.

Also called clinical investigator, investigator, primary investigator.

product locale

The language(s)—English or Japanese—of the product user interface components: menus, controls, commands, system screen labels, error messages, and so on. Oracle creates product locales.

See also review schema locale, study data locale, study locale.

protocol

The detailed plan for a study.

query

A question that the InForm application automatically generates, or that a CRA or sponsor staff manually creates, when data does not meet certain criteria.

query group

Allows any user who is in the same query group as the user who opened a query to change its status (for example, to close it). A user can be a member of only one query group.

randomization

An optional feature that you use to assign drug kits, devices, or treatments to subjects in a study.

RefName

A unique identifier for a study object definition.

regular form

A CRF that you use to collect data that is specific to the visit in which the form occurs.

repeating form

A CRF that can have multiple instances within a visit. A regular or common form can be a repeating form.

repeating visit

A visit for which you can have multiple instances.

reporting group

Defines the reporting functionality and type of access available to users with reporting rights. Some reporting groups allow members to access only standard reports; others allow members access to ad hoc reporting. A user can be a member of multiple reporting groups.

review schema locale

The language, set automatically during installation, in which data appears in the Data Viewer.

See also product locale, study data locale, study locale.

review stage

A status or phase within a Data Viewer review state. For example, Needs Review, Pending, or Reviewed.

review state

A step in a Data Viewer custom review workflow. For example, Medical Review and Data Management Review.

right

A privilege that identifies a feature to which a user has access through a rights group.

rights group

A collection of rights, the users who have those rights, and a set of item groups to which those users have special access. A user can a member of only one rights group.

rule

A script that runs in the context of one or more specific items on a form that checks whether data is valid, or that sets the value of an item based on a calculation, when data in the item is added or updated.

screening log

A page in the InForm user interface that lists candidates who have been evaluated for participation in a study.

serious adverse event

An adverse medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or lengthens a hospital stay; results in persistent or significant disability or incapacity; involves the development of cancer, a congenital anomaly, or a birth defect; or involves an overdose.

See also adverse event (AE).

signature

The process of attesting to the accuracy and completeness of the data captured on a CRF or in a case report book.

signature group

A group of users who are authorized to sign a specific set of CRFs. A user can be a member of only one signature group.

site user

An InForm user, typically a CRC or PI, who performs the following tasks: obtains an InForm site user name and password, registers subjects into a study, enters and changes clinical data in electronic case report forms, answers queries on clinical data, and prepares for monitoring visits.

source verification

The process of comparing data, which can be online or on printed forms, to data on source documents to check for inconsistencies or errors, and to record the results of the review.

sponsor user

An InForm user, typically a CRA, CDM, or medical monitor, who performs the following tasks: obtains an InForm sponsor user name and password, reviews clinical data queries, performs source verification, signs electronic case report forms, transfers subjects from one site to another, runs standard reports, and creates ad hoc (custom) reports.

standard report

A report that is included with all Reporting and Analysis installations.

started form

A form that contains data, a query, or a comment.

started visit

A visit in which at least one non-common expected form has been started.

study

The systematic investigation of a test article (such as a treatment, drug, or device) in human subjects.

study data locale

The language in which study data, most significantly text, is entered and stored.

Also called data locale. See also product locale, review schema locale, study locale.

study locale

The language(s) in which study metadata are designed using the Central Designer application. This includes CRFs and related study design labels, such as visit names, CRF (form) names, section labels, CRF questions, item control labels, auto-query text, and so on. A study may contain multiple study locales.

See also product locale, review schema locale, study data locale

study-specific clinical model

An Ad Hoc Reporting data model that is specific to a study, which contains references to subject data that site users enter on forms.

study-specific documentation

A study document that contains details about how to complete the items on a form.

subject

A candidate accepted into a study.

subject registration

The process of screening and enrolling subjects into an InForm study and creating case report books for them.

SV Report

A printed version of one or more CRFs that CRAs use to perform offline source verification.

See also source verification.

Time and Events schedule

A list of CRFs and visits for a specific subject that you use to review the status of CRFs and visits, and to navigate to specific CRFs.

unscheduled visit

A visit that occurs in addition to the visits required by the study protocol.

user name

The name the user enters to log in to the InForm application.

verified

A form state that indicates that there are no unverified items on the form. If a form has items that require verification, the items have been manually verified. If a form has no items that require verification, the form state is automatically set to Verified.

visit

A subject evaluation checkpoint when data is collected.

visit calculator

An optional scheduling aid that enables you to compute and print suggested visit dates based on the subject start date.

Also called subject schedule.