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H2R

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H2R

Re: WHSmith post# 32092

Friday, 06/26/2020 4:32:25 PM

Friday, June 26, 2020 4:32:25 PM

Post# of 44552
My guess is about 6 weeks after data lock.

As far as I know, we don't have data lock (I have not see a filing or a PR on it). They could data lock without a PR. For me, the clock start ticking at data lock. Before that, there is just too much to contend with. It's a big trial, COVID may divert hospital resources away from trial communication with the CRO, even if it's just a couple of hold-outs. Each site must finalize their 'own data lock' if you will (maybe not the exact term), queries may be outstanding... Even if the CRO says it's 'close', as long as it's not over, no starting of the clock.


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