PARADIGM

Registration-Randomisation Software

An Introduction

The PARADIGM registration-randomisation software enables doctors and their staff who have access to Internet, or EuroCODE, to interactively register patients and obtain a randomised treatment allocation from their own computer.

It allows patient registration 24 hours a day, 7 days a week, and 365 days a year. This is especially important for international collaborative studies where there may be a time zone difference. Alternatively, clinicians may telephone the co-ordinating data centre who will use the program to carry out the registration on their behalf.

Features of the program include computer checking of eligibility criteria, direct confirmation of patient entry by fax, email or mail, and statistics on studies available at any time. The software is all menu-based and studies may be set up quickly and easily.

The patient registration and randomisation software is a collaborative development between the Netherlands Cancer Institute and the MRC Cancer Trials Office, written according to the specifications of the EuroCODE group. It is written in a powerful database language which may sit on a variety of databases such as INGRES, ORACLE, C-ISAM and ASCII files.

This page gives an introduction to the patient registration and randomisation software, and gives details on how oncologists and other cancer professionals may obtain access to the EuroCODE network, or obtain their own copy of the program, in order to register patients and access the full range of services.

How to use PARADIGM

Logon to the PARADIGM computer in your country either by telnet or using a modem.

You will then be presented with a login prompt. Enter your login name and password. Use lower case letters .

You will then enter the randomisation software.

 

If you are an external user, ie if you are logging in from outside the hospital, then the options you will be presented with will include the following:

This enables you to register patients into registered clinical trials held at this node.

Choosing this option, will give you access to gopher and World Wide Web Cancer Information Services, including the renowned Oncolink, and PDQ.

This provides access to the European Register of Trials, which contains information on open and closed randomised trials with patient intake from Europe.

This provides you with an easy to use program in order that you may use your account to receive and send electronic mail.

If this is the first time that you are using your account, then please use this option to change your password.

Setting up a Study

The study definition program is an easy to use, menu-based program which enables a data manager to set up studies themselves, defining the required registration questions, eligibility criteria, stratification factors and treatments.

There is a comprehensive user manual accompanying the program which explains all options in detail. This page is intended simply to give an introduction to the process of setting up a study and to the features it supports.

The option general enables you to define study information such as name, description, phase and target accrual.

The option 'organisation' from 'edit' menu enables you to define the study owners - the only ones who may edit the study, the study coordinator(s) and for restricted access studies the clinicians who may enter patients.

The option 'forms' allows you to define the questions that are asked at registration, and/or randomisation(s). Questions that are always or frequently asked need not be redefined and may be automatically added to each new study.

The option 'treatments' enables you to set up the randomisations and treatments to be allocated. The program supports different ways of assigning treatments such as minimisation, block and double blind randomisations with any number of treatments and equal or non-equal numbers on each arm.

The option 'notifications' from 'forms' menu enables you to define automatic confirmation letters to send to study investigators, study coordinators and others on the entry of a patient. These are automatically printed, faxed or emailed.

Once a study has been defined it must then be validated, using option 'validate'. This option allows the study definition to be checked and test patients to be entered in order to verify the definition. A study may be printed for a paper record of the questions asked. Once validation is complete the study may then be opened, and registration of patients can commence.

Registering a patient

In order to randomise or register a patient choose the Patient Registration-Randomisation option. Data centre users are then presented with several options in order to monitor the studies, and must again choose Registration - Randomisation.

You will then be presented with a menu of all the clinicians for whom you may register a patient. Use the UP and DOWN keys, or 'find' followed by ENTER to select the clinician you want. Once a clinician has been chosen, a menu of the hospitals that the clinician currently works for is displayed. Select the correct hospital.

You are next presented with a menu of all the open studies and asked to select the study you wish to register the patient onto. Choose the correct one, either using UP and DOWN or 'find'. Some studies are restricted access, and require that the clinician is registered at the data centre prior to entering a patient.

Now you are asked all the registration questions. If the answer given is of the wrong format, or yields an ineligible answer then a menu is displayed which allows you to re-input your answer, go back to the previous question or quit without randomisation. If you make a mistake and want to go back or quit, press F2 or CTRL-D to bring up a menu to enable you to do this.

Once all questions have been asked, then a moment will pass whilst the patient is registered then a screen displaying the patient number and treatment allocation is displayed.

Finally you are asked whether you wish to randomise another patient for this clinician. Choosing yes will bring you again to the menu of studies, and choosing no will return you to the main menu.

FACILITIES FOR STUDY MONITORING

Data centre users, at centres coordinating trials, have further facilities beyond registering patients. It gives the data centre study monitoring facilities such as viewing the patient data, and exporting this information to packages storing follow-up data. For data protection, external users will only be able to submit data and not to read previously entered records.

DATA REPORTING

This enables data centre users to view the patient data entered and to view summaries of the patients entered. The patients may be listed by study or for all the studies at the data centre. It also enables a notification to be regenerated, in case of loss.

DATA EXPORT

This enables the patient data to be exported to packages including SAS, MS-ACCESS, COMPACT, and SMART.

STRATA TOTALS VERIFICATION

This is for minimised studies and it allows the number of patients allocated to each treatment to be viewed, printed and verified.

PRIVILEGED OPERATIONS

These options are only available to privileged data centre users, normally only a single person at a node. These options include 'manual randomisation' ie to allow the treatment to be chosen, in cases where the randomisation has been done elsewhere or not using the program and enables a patient to be deleted if they have been entered in error.

ADDRESS BOOK FOR CANCER

This provides participation lists for all the investigators, institutes and centres involved in each study. Other work groups may be set up and labels, and mail merge files produced in order to aid data managers in managing the studies.


HOW TO GET ACCESS


There is no charge for entering a patient, or using any of the services held at your local EuroCODE node. In order to obtain an account you should contact your local EuroCODE representative, who can also provide you with a comprehensive user manual.

The Registration-Randomisation program may be acquired by other interested data centres. In order to set up studies and act as a data centre for the Registration - Randomisation software you must run a version of both the program and the package Supernova at your site.

For further information you may contact :

Linda Jenkin, The Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam. Tel: + 31 20 512 2665, Fax: + 31 20 512 2679 Email: laj@nki.nl

 

In order to enter patients into studies held at the NKI see the instructions below. For patient entry at other sites running the software please contact the data centre concerned.

To connect to the NKI:

Dial +31 20 512 2676 if you use a PC equipped with a modem

type telnet eurocode.nki.nl if you are connected to internet