Chapter 5. openCDMS Create

Table of Contents

Wizard Set-up
Wizard Page One - Study Identifiers and Properties
Wizard Page - Study Stages
Documents
StudySchedule
Menus
File Menu
Study Menu
Help Menu
Main Design Window Overview
Tree Views
The Document Panel
The Entry Panel
Configuration of Documents
Document Properties
Document Sections
Configuration of Entries
Basic Entries Properties
Manage Units
Manage Validation Rules
Manage Transformers
Collaborative Study Editing
Study Statuses and Valid Next Statuses
Participant Register
Randomization
Strata
Treatments
Block sizes
Randomization Emails
Randomisation Trigger
Reporting
Validate Study
Manage Import Maping
Autosaving
Glossary
Study
Document
Section
Entry
Centre
Site
Study Stages
Transformers
Units
Validation Rules
Roles
Status
State Transitions
Consent Form
Database
Library
Overview
Elements explained
Saving elements from a study
Importing elements into a study
The Library View
Library Information Dialog

openCDMS Create facilitates the design and configuration of studies (datasets) to be used for data collection with openCDMS Collect. This guide describes how to quickly set up a study and the features and settings available within the openCDMS Create application.

Wizard Set-up

A wizard feature for quick creation of studies. Use the 'Next' and 'Back' buttons to navigate through the wizard. The 'Finish' button will create the new study and the 'Cancel' button will dismiss the wizard without creating a study.

Wizard Page One - Study Identifiers and Properties

The initial wizard page for configuring a study. The 'Next' button will not be enabled (clickable) until a Study Name nad Study Code have been entered.

Study name

A short name for the study should be entered in this field (e.g. Outlook or National Eden). This is used (in conjunction with the study code) to uniquely identify the study. If you enter a name for the study that already exists in the database (i.e. a name that represents another study that has been saved either by you or by another user), an error dialog will be produced when you click 'Next' and you will not be allowed to proceed. New studies must have a unique name and study code.

Study code

A short code for the study (e.g. OLK or NEDEN). This is used for study identifiers (e.g. OLK/001001-1 might identify the first participant in the Outlook study in the Manchester centre). The code is always used for display purposes in the various openCDMS applications. The study code is used (in conjunction with the study name) to uniquely identify the study. If you enter a code for the study that already exists in the database (i.e. a code that represents another study that has been saved either by you or by another user), an error dialog will be produced when you click 'Next' and you will not be allowed to proceed. New studies must have a unique name and study code.

Study Description

A short overview of the study aims (e.g. "A study to track a large, representative cohort of individuals with first episode psychosis").

Study scope

Describes the geographical scope of the study - either a single centre study or a multi-centre study. Note: this option is not available to studies without preconfigured centres.

Study centre

Set the name of the single-centre for the study here. Note: the option is not available to studies without preconfigured centres.

Use randomisation

An on/off flag for setting whether the study is to be randomised or not. If selected, randomisation settings must be completed before the study can be successfully saved to the database. For more information on randomisation settings, see the section on Randomization below.

Wizard Page - Study Stages

This is the second page of the study wizard and requires entries to define the time stages in the study for which documents must be completed (e.g. Screening, Baseline, Day 1, Day 7 etc.) Clicking the 'Add' button produces a dialog that requires a name for the new Study Stage (e.g. 'Screening'). When 'ok' is clicked in this dialog, the study stage is added to the study and is displayed in the list of configured Study Stages in the list.

Reorder Study Stages

Select a study stage in the list and then use the up and down arrow keys to change the order of study stages for the study. This is a useful option if an error is made in the original addition of studies (e.g. 'Day 7' is added before 'Day 2').

Documents

A list of all possible documents that must be completed for the study (e.g. Medical History, Vital Signs). A document represents a form or assessment that must be completed for the study.

Reorder documents

Select a document in the list and then use the up and down arrow keys to change the order of documents for the study. The reordering functions similarly to the reordering of study stages described above.

StudySchedule

This wizard page that displays a grid for describing which documents should be completed at which stages in the study. Click on a square in the grid to select or deselect. It is possible to assign a document to more than one than one stage. Each document must be assigned to at least one stage.