Glossary

Chart

An entity that can graphically display various rows from a [Data View] and be placed on a report.

Collapsed Intervals

A data set that is exported with collapsed intervals will display with one row per subject (all data for a subject is in one row).

Data Set

An entity that describes a particular set of variables to be used in an export or Workspace.

Data View

An entity that defines a set of data aggregations to be used in either charts or tables.

An encounter in StudyTRAX is a contact with a subject, typically a visit. An encounter can be a fixed encounter used for data collection whose schedule is known (e.g. Baseline, Month 1, Month 6). A subject can only have one occurence of a specified fixed encounter. An encounter can also be a non-fixed encounter used for data collection with an unknown schedule (e.g. tracking rejection episodes after a transplant, an unscheduled visit). A subject may never have a non-fixed encounter or may ha

Encounter Variables

Encounter variables are study-related variables collected at a specific interval.

File

A file that can be uploaded into a workspace. A file in a workspace is given a code and can be used in a report. Images are rendered in place in the report and any other file will have a hyperlink reference generated instead.

Filter

An entity used to limit the number of subjects included in a data set or workspace.

Interval

An entity that defines a follow-up event. This is most commonly a clinic visit.In a fixed follow-up project, this would represent one visit at a given point in time whereas in a non-fixed follow-up project, this may represent one type of visit. Non-fixed Intervals are often used to capture adverse event data as well.

Medication Group

A Medication Group is a mechanism to define a dose equivalency scale for related medications for use in a data set. A Medication Group allows related medications to be organized into one column of a data set export. For example, a medication group can be created so all analgesics used by a subject are represented in a medication group in their morphine equivalence.

Output Interval Groups

An Output Interval Group is a way of re-combining subject encounters into intervals. Output intervals are used to apply encounters to different interval structures during the data export process. StudyTRAX allows the user to set up any interval structure and it will find the encounters closet to that output interval and put in that encounter's values in the data set.

Project

A project in StudyTRAX is typically a research study, clinical trial, or patient registry.

Project ID

The Project ID is an alpha-numeric value up to 80 characters in length to identify a subject within a project. The Project ID must only be unique within a project.

Project Variables

Project variables are study-related, single occurrence variables not associated with a specific interval (e.g. discontinuation date, blood type).

Randomization Blinding Methods

The blinding method determines what is displayed on the Subject Overview page after a subject is randomized.

Reference ID

The Reference ID is an alpha-numeric value up to 80 characters in length sued to identify a subject in StudyTRAX. The Reference ID must be unique across all projects and should not be project specific (e.g. medical record number, social security number).

Report

An entity that shows summarized data. There are 3 types of reports in StudyTRAX: Canned, Subject, and Custom.

Sites

Sites represent physical data collection areas. Each project must have at least one site. Any site may be used in one or more projects. When assigning users to a project, the roles the user performs within the project are assigned at the site level. For a particular role, the user will only have access to the subjects assigned to site(s) that the user has access to within the role-appropriate function. For example, if a user has a Subject Management role for Site 1 and a Data Set role for S

Table

An entity that allows a [Data View] to be formatted into a tabular form that can be included on a report.

Universal Project Variables

Universal project variables are customized attributes used to capture the characteristics of a project; they are not study data. The universal project variables defined are available for every project in the system through the Attributes tab of the Project Overview page. Protocol Number is an example of a variable that could be collected as a universal project variable.

Universal Subject Variables

Universal subject variables are used to capture static subject characteristics that are common across all or most projects (e.g., sex, birth date, and death date). These variables only need to be entered once and can be used across all projects. Note that each project can specify which universal subject variables will be exposed within their project. For example, birth date may be defined as a universal subject variable but only displayed in the projects that are interested capturing a subjec

Users

Users are individuals given access to StudyTRAX. In System Setup, user accounts are created, and if appropriate can be assigned to one or more system-level roles. Users that need project or site level roles will not be assigned any roles in System Setup, the assignment of project and site level roles is peformed in Project Management.

Variable

A variable is a user-defined data collection point.

Variable Group

A Variable Group is a collection of variables that are related. Each variable group has two primary components: a descriptive label (name) and a collection of associated variables. A variable group in StudyTRAX is typically a case report form or questionnaire.

Workspace

An entity that contains Data Sets, Data Views, Tables Charts, Files, and Reports. A workspace is an organizational unit used to collect all data related to a specific set of analyses.