Onyx can be customized to meet the needs of any organization that is collecting data from participants for a medical reseacrch study. Customizing Onyx invloves creating custom questionnaires and configuring Onyx to collect the physical measurments and biosamples required by the study.
Planning Your Customization
To the Organization that is Customizing Onyx
We recommend that you plan your customization of Onyx using this spreadsheet. The completed spreedsheet will serve as a guideline for the programmer who will carry out the customization of Onyx for your organization.
|Item||Explaination||What you need to do|
|Enrollment mode||Onyx can manage participants with appointments or walk-in participants or both.||Decide which enrollment mode(s) you will use.|
|Participant information fields||
Before the consent stage, Onyx can capture some identification
information about the participant. This information is either provided
with the appointment list or obatined when the participant is received.
Mandatory fields are: participant ID, name, and DOB. Other fields are configurable.
Onyx does not assign participant IDs. The study does. We need to know
the format of your participant IDs so Onyx can validate them when
participants are received. Participant IDs can be on barcode labels.
Define a list of participant information fields.
For each field, define:
Onyx stages (consent, questionnaires, physical measurements, biosample
collection) can be listed onscreen in any order that is convenient for the study.
Define a list of the stages in an interview; in the order that you
want them to appear onscreen.
For each stage, define:
|Consent form||The participant's signature can be obtained in various ways: Manual, electronic, or both.||
Decide which signature modes will you use.
If you will accept consent electronically, prepare the consent form in
One or more questionnaires can be defined.
The questions in a questionnaire should be grouped into pages
(questions that you want to appear on the same screen). Questions can
also be grouped into sections (by topic).
You can define "skip patterns"; whether or not to display certain questions based on
answer(s) to previous question(s). A skip pattern can be for a page (hide some questions
in the page initially and only display them if the participant gives a particular answer to
another question in the page). A skip pattern can also be for a section (do not display
section about smoking if participant is a non-smoker).
A questionnaire can be displayed in different modes:
For each questionnaire, define:
For each question, define:
We recommend that you define a preliminary questionnaire to establish if any physical
measurements or the collection of certain biosamples are contradicated.
|You need to define the same information as for any questionnaire. In addition, we need to decide which answers contradindicate which stages.|
|Physical measurement stages||
A physical measurement stage usually acquires one type of measurement on one
instrument. However, if several measurements are normally taken together, they can all
be grouped in one physical measurement stage.
Measurements can be entered manually or automatically captured from electronic
instruments (if instrument has its own application, or both.
A measurement can be obtained once or multiple times.
Define the list of measurements to be acquired.
For each measurement, indicate:
|Biosample collection stages||
Several types of sample can be acquired.
Multiple samples of each type can be acquired.
One or more sample collection stages can be defined: one type of sample per stage, or
several types per stage; whatever is convenient for the study.
Barcode labels on samples can be scanned. The barcode can have a syntax (participant
code, sample type, incremental number, and so on).
List of sample collection stages and type(s) of samples to be collected in each stage.
For each sample collection stage, indicate:
|Report(s) to be given to the participant||Optional. You can define one or more reports that staff can print and give to participants after completing a stage or at the end of the interview.||
Define a list of report(s) that will be printed and given to the participants.
For each report, prepare the test in a Word document.
|Interview conclusion||Optional. You can define a conclusion stage. For example, a checklist for staff members to go over at the end of the interview.||Define the text display onscreen.|
|Experimental conditions||Optional. You can define one or more logs in which staff will record experimental conditions. For example, you could have one log for "Room Conditions" (like temperature and relative humidity), and another log for "Location Characteristics" (like meters above sea level).||
Define a list of logs.
For each log, define:
For each condition, define:
Optional. You can define calibration procedures for physical measurements.
For a particular physical measurement, your staff might need to perform one or several
calibrations. For example, for a measurement of "Standing Height", they might need to
calibrate "Vertical Alignment" and "Accuracy"
A list of the calibration procedures.
For each calibration, indicate:
For each calibration variable, indicate:
Data can be exported to xml files.
You can define:
The names of export files will be composed of the destination name and the date and
time of export.
Define a list of export destinations
For each export destination, define:
For each type of data, define:
Who should read this Guide
This guide is mainly for Onyx customizers. By a customizer we mean a programmer who has been asked by an organization to customize Onyx to meet the requirements of their research study. Ideally, this person is somewhat or very familiar with Java and how Java implements web applications. The result of the customizer's work will be a war file that will be used to install the custom version of Onyx on a server at the site where Onyx will be used.
This guide may also be used by Onyx installers to tweak the Onyx configuration immediately after installation or later. By an installer, we mean the person who will set up the Onyx server and workstations at the site where Onyx will be used. An installer may be a system administrator, an IT person, or even the customizer.