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Guidelines for Randomisation in Clinical Study

This document outlines the steps for randomisation in the clinical study via a secure website. Users can access the randomisation system by logging into the provided link. A telephone backup system is available 24 hours a day. Before initiating randomisation, it is crucial to ensure study oximeters are marked as 'available for use' and complete Part A of the Study Entry Form. If allocated oximeters are missing or damaged, users can log in to change them. Proper completion of all eligibility questions is mandatory to proceed with randomisation.

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Guidelines for Randomisation in Clinical Study

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  1. Randomisation • Randomisation via secure website • https://rct.npeu.ox.ac.uk/boost/ • Telephone backup system available 24 hours a day

  2. Randomisation • Login: • Select centre • Enter username • Enter password

  3. Randomisation • Before randomising, study oximeters must be assigned as ‘available for use’ • Login to randomisation website • Select Assign new oximeters as ‘Available for use’

  4. Randomisation • Complete Part A of the Study Entry Form before randomising • Login to randomisation website • Select Randomise baby

  5. Randomisation • If the allocated oximeter cannot be found or is broken: • Login to randomisation website • Select Change oximeter (non-routine) If possible, a new oximeter will be allocated

  6. Randomisation • Randomisation cannot proceed if all the eligibility questions are not completed properly

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