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How to submit information which reveals treatment assignment in a double-blind study (so-called "unblinding information")

Solution

Consider the following

  1. the applicant is the principal investigator who is supposed to be blind to the treatment assignments, and

  2. a SUSAR or DSUR needs to be submitted where treatment assignment is revealed.

If the SUSAR/DSUR is submitted through normal channels via BASEC, the PI, through his access to the study as stored in BASEC, will be unblinded.  

In that case, the Sponsor can send the unblinding information per email to the responsible (lead) Ethics Committee. The Ethics Committee will confirm receipt. Please note that unblinding information is the only information that will be accepted via email, outside of BASEC

 
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