Confirmation of Unblinding

Please confirm that each of the following conditions have been met prior to unblinding

• Unblinding is medically necessary in this situation (knowledge of treatment allocation will alter the participant’s immediate clinical management) and cannot be managed by assuming a trial participant is taking the highest active dose of any IMP and by withholding the trial medication.
  
  
• The unblinding clinician has considered making contact with the MRC CTU at UCL trial team or the local trial team at the recruiting hospital (in the case of unblinding by a doctor not involved in the trial) to discuss the case. Note that, where this is not possible (e.g. for out of hours emergencies) or where the clinician feels that emergency unblinding is essential in order to manage the case, unblinding should not be delayed.
  
  
• The unblinding clinician is aware that information relating to treatment allocation is to be shared with as few people as possible (in general, only those people involved in the participant’s immediate clinical management). It should not normally be communicated to staff at the MRC CTU at UCL nor to the participant.