International Association under Belgian Law
ORTA USER GUIDE
EORTC Data Center
Version 2.1
24 May, 2000
Registered Office: avenue E Mounier 83 Bte 11 • 1200 Brussels • Belgium • Phone: + 32 2 774 16 11 • Fax: + 32 2 772 35 45
E-mail: [email protected]
EORTC Data Center
May 24, 2000
TABLE OF CONTENTS
RANDOMIZATION
3
Overview
3
Accessing Orta
Username and password
Login to Orta
Passwords
3
3
4
5
Registration/Randomization
Identification screen
Eligibility checking
Registration/Treatment allocation screen
Review patient details
5
5
6
7
8
Utilities for reviewing patient details
8
Support
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Randomization
Overview
The Orta Registration/Randomization system is a web-based application designed
to facilitate the registration & randomization of patients in EORTC clinical trials.
Registration/Randomization is the process whereby a patient is entered into an
EORTC study. The Registration/Randomization process checks the investigator's
authorization to randomize to the study, then checks the patient's eligibility, and
finally assigns the treatment and patient seqid. Access is controlled through user's
name and password, and actual randomization is controlled through an
authorization list maintained by the Data Manager (using the ManaRand module).
Registration/Randomization is done in 4 phases using a web browser (e.g. Netscape
or Internet Explorer). These steps are: Logon, Identification, Eligibility checking,
and Seqid allocation (plus treatment allocation for Randomized Trials).
Accessing Orta
Orta is available at this address http://www.eortc.be/random
No specific software needs to be installed to access the system. Orta is available
from any 4th generation browser (Netscape 4, Internet Explorer 4, …) and above.
Username and password
To enter the system you need to have a username and a password. You can request a
username on-line by filling the form available from the Orta main page (see above)
Your username and password will be sent to you by e-mail
DON’T FORGET TO GIVE YOUR EMAIL ADDRESS & YOUR EORTC
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INSTITUTION NUMBER
Account request web page
Login to Orta
Once you receive the confirmation of your account by e-mail you can enter the
system.
Orta logon web page
Identify yourself by entering your username and your password. Click on LOGIN.
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NOTE: The system is case sensitive for passwords (Uppercase and
lowercase must be respected).
Passwords
The password that you receive is a temporary password, the first time you use it, the
computer will prompt you to choose another password.
Password expiration: Passwords expire after 3 months. You do not need to
connect every 3 months to change your password. When you connect with an
expired password, the system will ask you to choose a new one. You will have to
change your password to prevent any fraudulent access to the system. Choose
whatever password you like, but with at least 6 characters. A combination of
alphanumeric characters is preferable.
Change password web page
After you enter your temporary password, you can choose a new one.
Registration/Randomization
Once logged on, you can begin the actual Registration/Randomization process. The
first step is to identify yourself and your patient.
Identification screen
The identification screen prompts you to enter your details, as well as the study,
protocol, and patient details. Certain fields allow you to check the validity of the
information by displaying a list of acceptable choices.
Access beyond this point is only allowed for studies for which you have fulfilled the
necessary requirements for participation (Ref. ICM-GCP).
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Identification web page
The fields that you have to fill-in are
Institution number
EORTC Institution number
Protocol
Protocol number
Click on “Details” to get details about this
protocol
Step
Normally 1, however some studies have several
steps. Mention here the step in which you like to
enter the patient
Responsible physician
name
and first name
Correct spelling will be checked with our address
database; in case of misspelling a list will be
displayed for selection, with all official members
in your center.
or
Click on “List Phys.” To select from a list of
names. Click one name to select it.
Please select the principal investigator name for
the study (= the name on the “Commitment
Statement/Study Acknowledgement” form of the
study).
Patient initials
Patients' initials: max. 4 alpha –numeric
characters (click “LIST” to select your patient in
step 2 or step 3)
Patient chart number
Patient chart number: optional but recommended
Patient birth date
Patient birth date. REMEMBER 4 digits for the
year, “/” as separation in day-month-year format
When all details are entered, click on “Start randomization” and, if your
institution has the authorization, if you have the right to randomize for this
institution and if the data you entered is correct, the eligibility checks will
start.
Eligibility checking
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The eligibility-checking screen comes after the identification screen.
Eligibility checking web page
Answer all questions as requested in the central window. Activate the cursor in the
"Your answer" box by clicking here with your mouse. Click “next” to continue to
the next question. Click “previous” to go back to the previous question
Pressing "Enter" has the same effect as clicking "next".
Click “back” on the browser toolbar to go to the identification screen.
NB: If this screen appears without the question boxes and the buttons, it means that
your browser is too old to run the program. Install a new version of Netscape or
Internet Explorer. These programs are free and available for download on the
Internet.
Registration/Treatment allocation screen
This screen appears after you have answered all eligibility questions.
It displays the sequence number of your patient and the treatment allocated.
Warning: the question numbers here are not the same as on the
randomization forms. Some extra questions (hidden) are usually added
for cross checks and eligibility checking calculations.
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Registration/Treatment allocation web page
Please write the patient sequence number (seqid) and the treatment allocated on the
randomization checklist.
Print the confirmation for your files
If, for any reason, you can’t see this screen, please call the Data Center for help
+32 2 774 16 00 or go back to the identification screen.
Review patient details
At the bottom of the Identification screen (see screen shot) there is a button
providing a way to review the details of all the patients entered for your
institution in the system. Click on the “REVIEW PATIENT DETAILS” link to
have the list of your patients, and then click on the patient initials to get a
copy of the randomization sheet.
Utilities for reviewing patient details
From the main identification screen, you can enter a protocol number, an institution
number and by pressing the "Review patients" button you will be able to check the
information you entered for your patients.
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After pressing the "Review patients" button you will see a list of patients.
Patient review web page
By clicking on the initials, you get the registration/randomization information
(checklist, birthdate, ...) for each patient.
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Patient registration/randomization details web page
The page that is generated is formatted to be suitable for printing.
By clicking on the small square before the patient's initials on the Patient Review
web page, you get the registration/randomization information and the phrasing for
each question.
Patient randomization questions detail web page
Press you browser's "back" button to go back to the list of patients.
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(End of Chapter - Randomization)
Support
For further information and support, please see the FAQ (Frequently asked
questions) section on the Orta web site ( http://random.eortc.be/doc/faq.htm )
Or contact:
Pascal Ruyskart ([email protected]) , Ann Marinus ([email protected])
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