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21st Nov 2024, 07:15 AM
#1
Availability of unblinded treatment allocation
What should be done with the record of treatment allocation (e.g. opened randomisation envelope) following [emergency] unblinding of a trial participant?
My impression is that once the participant has been unblinded, "the cat's out of the bag" so to speak, and there's generally no point maintaining secrecy amongst all site staff if the investigator +/- coordinator now know the treatment assignment. The treatment allocation should therefore be filed in the source documents.
Obviously this would be subject to any trial-specific stipulations, and I can think of reasons to keep the allocation secret from some parties, like the below examples. But I'm mostly looking for a general rule here.
- The sponsor wouldn't necessarily need to know (other than the fact that unblinding has taken place)
- Any independent rater at site would need to remain blinded
Look forward to hearing your thoughts!
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