Randomisation and blinding

Ensuring integrity of the trial through a randomisation and blinding process



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Clinical trials often involve a randomisation process which require careful planning to ensure integrity of the trial. Trial staff should then follow the trial randomisation procedures to ensure that any blinded code is broken only in accordance with the protocol. As such, this procedure describes randomisation and blinding for a clinical trial, which may be supplemented with a trial-specific process document(s).