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marzan

06/27/19 2:28 PM

#234851 RE: flipper44 #234849

no flipper, please you are the one adamant not to believe in Soft Lock, I beg your pardon. The Query discussion only erupt when you come to the data lock stages. There are two stages of data lock, one is soft and the final is hard. Query word is used only during this time. I agree with you SAP might be the showstopper now. And data scrubbing might well be done over. But the most time consuming process in the unblinding is Queries and Scrubbing and this take long very long in my mind. SAP is a document here with your non proportional hazard accounted for; OS will decide the outcome anyway. Sorry, had I been persistent.
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sentiment_stocks

06/27/19 7:54 PM

#234886 RE: flipper44 #234849

I agree that the soft sat lock discussion doesn’t really matter. I don’t think anyone including myself intended to sow confusion; although that was somewhat what ended up happening. But in the end it seems to me that the soft data lock will likely be very closely behind the hard data lock. As they approach the time when a hard data lock is feasible, they will inquire of the CRO how far back in time they must go to capture all the perfectly scrubbed data. And when they are finally ready to hard data lock, then they will back the clock officially to the point in time where the CRO can assure that data is entirely accurate and there are no more existing queries to be answered.

Pretty simple really. But it’s a little confusing at first... kind of like thinking of the survival curve in this trial really being just one continuous timeline, despite all the years over which these events have occurred in real time.