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I can’t help feeling too much is being

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Horseb4CarT   Monday, 06/22/20 08:04:44 PM
Re: biosectinvestor post# 290985
Post # of 311810 
I can’t help feeling too much is being made of soft vs hard trial database lock.

It seems to me the difference is largely that prior to either lock there is a team of people under the CRO that are simultaneously validating the trial data and making changes to the database as required.

When all the data is validated to the maximum extent that is to be extremely, filling previously missing data items and addressing the anomalous or questioned data, the database would be locked and no further change can be made.

Soft lock appears to be a potential intermediate step which I would venture may be used where the database has essentially been validated except perhaps waiting on a small enough set of i’s to be dotted and t’s to be crossed so to speak, that the database is close enough to final to propose soft lock presumably allowing the data to be unblinded for the statistical analyses to be performed. During soft lock only one person is able to make the final remaining changes leading to hard lock.

Either state of lock would be significant to advancing to TLD since even soft local would only be worth doing if the database is close enough to allow the stats work to begin. I’m also guessing that when hard lock is declared the stats would quickly be completed.

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