First of all the ICH definition - Blind Review is the checking and assessment of data during the period of time between trial completion (the last observation on the last subject) and the breaking of the blind, for the purpose of finalizing the planned analysis.
So how do we do it ? We look at the Clinical Protocol and create a Blind Review Criteria document which will list out all the conditions that needs to be checked against the data to make sure that there is no violations. For eg. if Visit 1 were to happen with in 15-20 days of the screening visit, then we compare the dates of screening and visit1 and if the difference falls below 15 and above 20, then boom we have a violation. Then we write a SAS program to check all those conditions and run it to create a protocol violation document.
Easily said. But to do it and to make sure that all the violations are caught is one hell of a task Johnny.
So how do we do it ? We look at the Clinical Protocol and create a Blind Review Criteria document which will list out all the conditions that needs to be checked against the data to make sure that there is no violations. For eg. if Visit 1 were to happen with in 15-20 days of the screening visit, then we compare the dates of screening and visit1 and if the difference falls below 15 and above 20, then boom we have a violation. Then we write a SAS program to check all those conditions and run it to create a protocol violation document.
Easily said. But to do it and to make sure that all the violations are caught is one hell of a task Johnny.
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