A

Activation Worksheet – This worksheet defines the activation properties.
Alert – An automated edit check that is triggered during data entry for real-time data cleaning.
App Properties Worksheet – This worksheet defines application-wide string properties that may be used for display or report configuration.
Application Setup Worksheet – This worksheet defines attributes that affect how the application functions.
Approve Environment – The environment in which all external customer User Acceptance Testing takes place.
Assignment Worksheet – This worksheet allows a defined question to automatically be assigned to a value.

B

Branches Worksheet – This worksheet defines Branching. Branching is an expression that will forward the user to a certain form if an action is performed. For example, if the patient enters data that disqualifies the user from the study, once the question is answered and the form is saved, the user will be taken to the Study Termination form.
Bridges Worksheet – This worksheet defines the bridges between the study or sites and the randomization managers.

C

Clinical Research Platform – The clinical enterprise solution that is made up of all the products contained within the Fountayn Platform.
Codes Worksheet – This worksheet defines the Medical Coding Configuration.
CodeLists Worksheet – This worksheet defines the available code lists for use in the Question Types – Definition tab.
Component – A component is a feature or subset of features of a Product.
Configuration Worksheet – This worksheet defines the randomization configuration for the study or a site.
CRF – Case Report Form
CTMS – Our Clinical Trial Management System (CTMS) provides 360 degree insights into the operational data of clinical research.

D

Data Architect – A component of the Fountayn Platform which allows for the configuration of applications for use in collecting data.
Data Review – An action taken on a form to mark the data as reviewed. This action is typically taken by a Data Manager prior to the source document verification process.
Fountayn Platform – The term used to encompass all products developed on Fountayn’s Java / Oracle platform. These products include, but are not limited to, the Fountayn Platform product suite, Trial Setup and Randomization.
Dependency – see Edit Check.
Dependencies Worksheet – This worksheet is used to configure dependencies for the question types specified on the Question Types worksheet. This worksheet helps define the definition XML file.
Design Environment – The environment in which designers can develop and test their work prior to formal testing.
Display Worksheet – This worksheet shows the layout of the unique forms in the trial.

E

eCRF – Electronic Case Report Form
EDC & Medical Coding – Fountayn’s Electronic Data Capture system allows users to obtain higher quality data faster through the EDC products’s seamless data integration and usability among data entry, coding, randomization, inventory and reporting tools.
Edit Check – Dependencies that can be placed on questions to check the entered data against predefined rules or other questions.
Enterprise Manager – The tool used to manage user access to trials.
Email Triggers Worksheet – This worksheet defines the email triggers set up. Create one definition set per email configuration.
Error Messages Worksheet – This worksheet defines the error messages that are displayed to users.
Export Worksheet – This worksheet defines attributes that affect how the export functions.

F

Feature – A distinct part of a product used to perform a particular task. Some features have to be enabled by a Fountayn team member or configured before they can be used.
Forms Worksheet – This worksheet defines the forms that will be used in the application.
Formulas Worksheet – This worksheet is used to configure variables that are added to the resolvable variable set for this application. These variables may then be used in reports, assignments, dependencies, workviews, etc. This is useful when you need to leverage data but do not want the data to be part of the exportable record.
Freeze – An action taken on a form during the data cleaning process to prevent data responses from being edited. This action is typically taken by a Data Manager.

I

Inventory Worksheet – This worksheet defines the inventory properties.

L

Lock – Typically the last step in the data cleaning process. When data is locked, no action can be taken on any aspect of the data. Depending on the study configuration, electronic signatures may be allowed on locked forms.

M

Maintenance Release – A Maintenance release may include any of the elements of a patch release and additionally must include at least one major enhancement.
Major Release – A Major release may include any of the elements of a maintenance release and additionally must include several major enhancements.
Module – A subset of features or components which represent a process or intended function.

P

Patch – A Patch release may include bug corrections, critical or minor enhancements, and minor routine maintenance updates.
Patient – A Patient is an entity that participates in a study. Each form in the eClinical system uniquely belongs to one patient. There are different opinions on the term that should be assigned to this entity. Usually the term Patient or Subject is used here. Fountayn Platform technologies allow the configuration of this term within the DataArchitect Setup. Depending on the recordName configuration, you handle Patients in the Patient Manager, Subjects in the Subject Manager, or Mice in the Mouse Manager. Be aware that whenever you read Patient in the Learning Center, the entity could have a different label in your application.
Patient PDF – The PDF file pertaining to a specific patient that is part of the PDF archival export; by default this PDF contains the patient’s casebook
Products – A group of modules within the Fountayn Platform that perform specific functions.
Production Environment – The environment in which actual clinical trial data is recorded and managed.

Q

Query – A manual query raised by a data manager or monitor in the system to question the validity of data entered by a site coordinator or investigator.
Question Layout Worksheet – This worksheet itemizes all data points (questions) in the application.
Question Types Worksheet – This worksheet determines how each question type is defined. This worksheet in conjunction with the Dependencies worksheet produces the definition XML file.

R

Randomization – The method to assign study participants to one of the available treatment groups while maintaining similar characteristics between the groups to prevent bias.
Randomization & Trial Supply Management (RTSM) – Fountayn’s RTSM system simplifies trial randomization and drug inventory management through robust Managers that allow users to view, filter, update and export information on drug containers, drug assignments, shipments and randomization schedules.
Record PDF – See Patient PDF.
Record Status – An automated patient status indication that changes throughout the course of a study based on changes to a patient’s casebook.
Roles Worksheet – This worksheet defines the roles that will be used in the application. The standard options for DataCollector are provided in the Roles template. For each Action there is a list of Actions Required and Screens Required.
Reports Worksheet – This worksheet allows for the building of permanent reports in the Ad-Hoc Reports Manager. Creating a report here will make the report uneditable in the system.

S

Scripts Worksheet – This worksheet defines scripts that are used within the application.
Sign – An action taken on a form to ascertain that all data has been accurately recorded and reviewed. This action is typically performed by an Investigator.
Source Document Verification – An action taken on a form to ascertain that the data has been checked against the source document to verify accuracy of the data entered. This action is typically performed by a Monitor.
Strata Worksheet – This worksheet defines the strata used during randomization.
Study PDF – The main index.pdf file found in a PDF archival export; by default this PDF displays the study name
Subject – see Patient

T

Test Environment – The environment in which all formal QA testing takes place.
Tool – A tool is any object to which a user can be granted access. Tool types include: Sites, Query Workflows, and CTMS.
Tool PDF – The index.pdf file found in any site folder included in a PDF archival export; by default this PDF displays the study and site name.
Training – Fountayn’s Learning Management System allows you to manage all types of training and make use of both standard web-based training courses as well as a set of development tools used to create courses that meet the needs of your study team
Trial Design – Fountayn’s Trial Design, Deployment and Management system streamlines the entire design-to-deployment process by supporting the design, configuration, testing, user acceptance testing and trial deployment with a single tool.

U

Unified – Single sign-on, real-time, single database access to all portions of your data on the Fountayn Platform.

V

Visual Architect – A Web-based trial design tool which allows for the configuration of applications for use in collecting data.

W

Workgroup – The entity used to allow for the distribution of data between users of a clinical trial.
Workview Worksheet – This worksheet defines Workviews.
Workviews – Ad-Hoc reports that you can apply actions to such as updating specific fields with specified data. Each application can support multiple workviews.