Glossary
Ad Hoc Reporting
The Reporting and Analysis module, which allows you to create, run, and save customized reports on clinical and trial-management data.
adverse event (AE)
An undesirable symptom or occurrence that a trial subject experiences during or after a clinical trial.
association
The many-to-many relationship that can exist between two repeating forms.
audit trail
A complete record of changes that are made in the trial database.
case book
The collection of all case record forms (CRFs) for a single trial participant. Also called a case record book (CRB).
case record form (CRF)
A form that is used to record clinical data about trial participants.
clinical data
The data that is entered on a CRF.
clinical data manager (CDM)
A person who is responsible for preparing and maintaining a trial database and for reviewing data.
clinical project manager
A person who is responsible for all aspects of one or more clinical trials 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 trial-management data for reporting. Clinical reporting packages are unique for each trial.
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 trial.
Also called monitor, site monitor.
clinical research coordinator (CRC)
An assistant to the investigator at a site.
Also called site coordinator, trial coordinator.
clinical trial
See trial.
coding dictionary
A standardized collection of terms and the codes that correspond to those terms.
common form
A form that occurs in multiple visits and contains cumulative data.
content pane
The area that is located on the right side of the InForm window that displays CRFs, summary lists, CRF item details, and so on.
content-specific pane
The bar that is located at the bottom of the page that displays command buttons and navigation controls, which vary depending on what is displayed in the content pane.
control
A generic term for a form component, such as a radio button, checkbox, or drop-down list, in which you select or enter data.
control path
A sequence of IDs that define the physical location of a data point in the InForm database.
CRF help
A trial document that contains details about how to complete the items on a form.
customer-defined database (CDD)
An extract of the trial database that gives sponsor personnel access to the clinical data that is collected before the trial is completed.
design note
A comment about a form component.
display override
A property of items that can be set to Editable, Read-Only, or Hidden. Also called item blinding.
dynamic form
A form that is created in a trial only if certain conditions are met.
element
An option that you can select from a drop-down list, checkbox group, or radio group.
event
A component that specifies the action to take when a rule fails.
exclusion criteria
A list of admission criteria, any one of which excludes a potential subject from participation in a clinical trial.
execution plan
A script that is associated with an event, and that sends an email message or writes to the Windows event log.
expected form
A form that appears in the Time and Events Schedule for a patient, based on current known patient data. An expected form is a dynamic form that has been activated, or appears within a scheduled visit or a started unscheduled visit.
form
The data collection mechanism that is used in a clinical trial to gather patient data.
generic rule
A rule that the trial developer can attach to multiple items.
home page
The page that appears when you log on to an application.
inclusion criteria
A list of admission criteria that potential patients must meet to be eligible for participation in a trial.
InForm Reporting and Analysis
A reporting application, developed by Cognos Corporation, which has been customized and integrated into the InForm software by Oracle.
InForm Trial Management package
An Ad Hoc Reporting package that provides access to trial management data for reporting and allows users to share reports across trials.
Institutional Review Board (IRB)
A group that reviews biomedical research that involves human subjects.
investigator
The clinician who is responsible for treating patients, executing the protocol of a trial at a specific site, and filling out CRFs for patients.
Also called clinical investigator, investigator, primary investigator.
itemset
A collection of repeating items on a form.
medical monitor
A person who designs the trial protocol and reviews data.
navigation pane
The left side of the InForm window, which displays navigation buttons that you use to enter the functional areas of the InForm software.
package
A grouping of reporting elements from one or more data models. Two reporting packages are installed with every InForm trial: the InForm Trial Management package and a trial-specific clinical reporting package.
protocol
The detailed plan for a clinical trial.
query
A question that is automatically generated by the InForm software or manually issued by a CRA.
RefName
A name that uniquely identifies a trial component definition.
regular form
A CRF that is used to collect data that is specific to the visit in which the form occurs.
repeating form
A form that can have multiple instances within a visit.
rule
A script that checks whether data is valid or that sets the value of an item based on a calculation.
rule dependency
An additional item that is required for rule processing.
screening and enrollment
The process of adding a patient to a trial.
serious adverse event
An adverse medical occurrence that is life-threatening, or results in death or persistent or significant disability or incapacity; involves an overdose or the development of cancer, a congenital anomaly, or a birth defect; requires inpatient hospitalization, or lengthens a hospital stay.
signature group
A group of users who are authorized to sign a specific set of CRFs.
source verification
The process of comparing data that is on forms to data on source documents, checking for inconsistencies or errors, and recording the results of the review.
sponsor
The individual, company, or organization that is responsible for the initiation, management, or financing of a clinical trial.
standard report
A report that is included within all Reporting and Analysis installations.
started form
A CRF that is submitted or that contains data, a query, or a comment.
started visit
A visit in which at least one non-common expected form has been started.
SV Report
A printed version of one or more CRFs that CRAs use to perform offline source verification.
trial
The systematic study of a test article (a treatment, drug, or device) in human subjects.
trial management data
The metric and status data pertaining to a trial, which is used to report on the status of a trial relative to its completion.
trial-specific clinical model
An Ad Hoc Reporting data model that is specific to a trial, and that contains references to patient data that site users enter on forms.
unscheduled visit
A visit that occurs in addition to the visits prescribed by the trial protocol.
visit
A patient evaluation checkpoint when data is collected.
visit calculator
A scheduling aid that enables you to compute and print suggested visit dates based on the patient start date. The visit calculator page appears when a patient is enrolled and is also available as part of the trial documents.
