Randomisation

Last edited 21/02/17 by Priya Francis

Participants will be randomised via the EORTC Online Randomised Trials Access (ORTA) system. ORTA runs in a standard web browser, requires Java to be installed on the PC being used and can be accessed here. The log in details to be used are the same as those assigned for the EORTC database.

The ORTA system will show the following screen:















- The 'Institution number' can be found on the top of your screening log
- The 'Protocol' number will always be 1308 for the ROAM trial
- The 'Step' will always be 1 - New Patient for the ROAM trial
- Select the PI name from the list given
- The 'Patient code' will be the screening code assigned to the participant on the screening log
- The 'Patient birth date' will be entered and you will then click 'Start'

ORTA will go through the inclusion/ exclusion criteria, one by one. Once a participant is randomised, a message will appear detailing the allocated arm; this information will also be emailed to the PI/ROAM team. Approximately 1 hour after randomisation, the participant's CRFs will be visible on the EORTC database.

In case of problems randomising online, randomisation can be carried out via the EORTC call centre: (+32) 2774 1600. The call centre is available 09:00 - 17:00 (Belgian local time) from Monday to Friday. Randomisation via the call centre is not available on Belgian holidays - a list of these holidays is available on the EORTC website and is updated annually.
 




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