Randomisation – Emergency Unblinding

We are looking at how to provide back-up for blinded trials in the event that our online randomisation system is down.

 

In the past we have used sealed envelopes but we will be moving to a new system that automatically generates allocations and therefore we will no longer have the data file to produce the envelopes.

 

We are aware that others use this type of system and wondered if you would be willing to share your experience of dealing with emergency unblinding, specifically in the event that computer systems are down?

 

Thanks

Ruth

Database Management Team Leader

Newcastle CTU

[Author]

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