TRIAL TREATMENT: A participant was allocated usual care, but they have now been prescribed the trial treatment by their clinician; how do I record this?
The treatment the participant received should just be recorded on the follow-up form. It is not a protocol violation. If this happens too often it will seriously harm the trial, so staff should avoid recruiting patients to a treatment comparison if they are likely to receive that treatment regardless of allocation (although this will inevitably happen sometimes). This is monitored centrally, and the coordinating office will investigate if adherence to treatment allocation is consistently poor.