Unblinding
The process of revealing which treatment each participant received, either during a trial (for safety reasons) or at the end of the study for analysis. Emergency unblinding may be necessary if a participant experiences a serious adverse event requiring knowledge of the treatment received.
Technical Context
Emergency unblinding procedures: the investigator contacts the sponsor's 24/7 safety hotline (or accesses the IRT system) and receives the treatment assignment only if knowledge of the assignment would change the patient's acute medical management. The event is documented with justification. The unblinded patient typically continues in the study (to preserve ITT analysis integrity) unless the investigator determines discontinuation is necessary. Planned unblinding occurs at study completion or after database lock. The DSMB has access to unblinded data throughout the trial for safety monitoring but operates under strict confidentiality. Any accidental unblinding (e.g. through laboratory values, distinctive side effects, or labelling errors) is documented as a protocol deviation.