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Thursday, April 19, 2018 4:31:03 PM
data entered in database --> database as complete as is timely possible -->
database locked --> data unblinded --> analyse and report.
The point is: A clinical trial database is not like Starbuck's toilet door which gets unlocked and locked at request. When clinical trial database is locked it stays locked. Only exception I remember is predefined interim analysis and that is typical for long duration trials like cancer trials, where interim analysis for OS is performed typically at the same time as the nominal final analysis for PFS.
in our case here: all conceivable data must be in before any analysis. There is no separate lock date for topline data and for the rest of the stuff. That is my understanding, but it can be faulty understanding. Please advice.
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