Glossary
Time that a dose or observation actually happened (in UTC), as opposed to nominal time. See also Relative time and Clock time.
Analysis
Any type of procedure that results in information that describes a set of data.
Analytical method
The type of assay that was performed to assess the concentration of drug (or other compounds) in a sample, which is usually collected from blood, plasma, or urine.
Arm
Generally refers to a treatment or combination of treatments administered to a group of subjects or patients. For crossover studies, arm is sometimes used to denote a sequence group (a group of patients that received a particular sequence of treatments).
Assay
Analysis of a substance or mixture to determine the quantity of its constituents or to detect the presence of a substance.
Audit trail
A report that contains all additions, changes, and deletions made to the study data, units, observation data, and dosing data from Integral.
An independent variable in a Drug model, sampled before active treatment begins in a study.
Blinding type
Indicates which individuals involved in a study are allowed to see the treatments associated with data that is collected.
Time expressed as a date and/or time (in UTC), rather than relative to first dose or start of study. See also Relative time.
Column
A display of the attributes of each subject and for each subject data collection point in a study. Columns can also contain observation data, reasons for changing data (for the audit trial), etc.
Compound
The drug molecule under study. A compound may include one or more Formulation of that drug. The term is used in Integral to group studies that are investigating the same molecule.
Conversion factor
Part of an equation that enables conversion of data from one unit to another. For example, to convert from grams to milligrams, multiply the number of grams by a conversion factor of 1,000 to get the number of milligrams.
Covariate
An independent variable in a Drug model. Generally, some subject characteristic of interest, such as age or blood pressure. See also Baseline covariate.
Database
A file or set of structurally-related files that contains data. May contain one or more data sets. For example, in Integral, users log on to one database, in which they may access any number of data sets.
Dropout
Event at which a subject’s participation in a study ends.
Any combination of population PK/PD model(s), parameter and baseline covariate distributions, disease progress models, placebo models, adherence models, etc. A drug model may include one or more Structural model.
Duration
Length of an infusion dose.
End time
Time that a dose ends (for example, relative actual end time, relative nominal end time, etc.).
Thing that happened at a specific time: a single dose, observation, or unscheduled event. See also Unscheduled event.
Form
Description of the physical attributes (i.e., an indication) associated with a product (i.e., a molecule).
The point of dose input into a structural (PK/PD) model.
Formulation context
The dilution of the formulation.
Grid
A grid control, displaying data in a worksheet.
Group
Short for Treatment group.
Indication
An effect that is of interest produced by the application of a molecule. The FDA approves an indication, not a molecule. For example, the FDA approves Drug X for treating disease Y. The FDA does not approve Drug X in general.
Model
A set of mathematical equations that describe the underlying process of interest.
Model data
The information used to describe the process presented by the study data.
Time specified in the protocol for a dose or observation, as opposed to Actual time that a dose or observation was taken. Expressed relative to the first dose, or the start of the study, phase, or period.
Observation
A single piece of data for a subject collected at a particular data collection point. Observations can be explained, filtered, and analyzed by several defined dimensions. Each observation has associated audit information.
Observation data
Time-dependent events that contain some form of measured values. The data collected during the study.
Parameter
Variable defining the shape of a structural model.
Phase
A specific component of a clinical trial, such as lead-in or treatment.
Plot
A graph or chart of data.
Portfolio
A collection of molecules.
Product
Chemical entities (i.e., a molecule) under investigation in a study having an associated form.
Profile
A collection of data points described by a collection of unique identifiers, which uniquely identify subject responses for a particular situation.
Property
Column properties are settings for a data column, i.e. column name, type and default units.
Protocol
Planned activities in the trial, including: enrollment, lead-in phase windowing, study design structure, subject assignments, and scheduled treatments and observations for the lead-in, active and follow-up phases of the study.
Elapsed time since the first dose or the start of the study, period, or phase. As opposed to Clock time. Uses: relative nominal time or nominal_time_relative, relative actual time or actual_time_relative, relative actual end time or actual_end_time_relative. See also Nominal time and Actual time.
Savepoint
An analysis saved to Integral that requires an e-signature and represents a snapshot of the analysis and its results at that point in time. Savepoints are generated through the Integral Plugin for Phoenix or the Integral Client Application and are uniquely versioned by Integral automatically.
Sequence
Short for treatment sequence.
Simulation
Generally, a Monte-Carlo simulation.
Sort keys
A collection of unique database fields that distinguishes one set of data points from another (such as a plasma level profile). The difference between the sets of data points usually ascribes certain different attributes to the underlying processes being studied. For parallel trials, treatment and subject are generally the sort keys used to capture individual subject data, while treatment, period (or phase), and subject are generally used for crossover trials.
The set of functions defining the shape of a model (such as a structural PK, PD, or PK/PD model). Does not include parameter distributions.
Subject Identification
The ability to uniquely identify subjects is crucial to the functionality of the system. Since this application will be receiving data from many sources in many formats, no one unique identifier exists between the systems. Integral requires users to define a set of fields (data elements) that, taken together, can uniquely identify a subject for a study.
Subject identifier
That which uniquely identifies a subject from any other subject in a study.
Treatment
Combination of one or more drugs given at specific doses and times/schedule.
Generic term for a treatment arm (in a parallel study design) or treatment sequence (in a crossover or Latin square study design).
Unit
The unit of measurement associated with sample data that are collected.
Unit category
A group of units that measure the same thing (length, time, concentration, etc.).
A PD event with some probability of occurrence, such as an adverse drug reaction or subject dropout.
Workbook
A file that contains one or more worksheets.
Worksheet
A page in a workbook that contains a data grid.
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