Unblinding
In Running the trial
Also known as: code break, emergency unblinding
Unblinding is revealing which treatment a participant received. Emergency unblinding is permitted when knowing is necessary for that person's medical care, and is normally done through the IRT system so it is time-stamped and recorded. Any unblinding must be documented and reported to the sponsor, because it can affect how that participant's data is analyzed.
Example
A participant arrives at an emergency department overnight and the treating team needs to know what they received. The investigator unblinds that one participant through the IRT system and documents why.
Related terms
Career paths that use this
Turn the vocabulary into a career
The free CRLN Career Finder maps your background to a clinical-research role and builds a step-by-step roadmap. No cost, no card.
Get your free roadmap →Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.