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Thursday, April 23, 2020 8:10:36 AM
Do you think they will PR datalock?
If you mean NWBO, I would say I don't know.
I can't see why not.
It would mean (hopefully) that every single data query for every single subject, had been sorted and triple-checked.
And it was also mean that the CRO's task would have effectively been completed at that point.
Then they would be largely back in control of timescales themselves.
Any further Covid slippage is likely to be before datalock, because of the requirement to physically check records, including on-site.
The process after datalock should be achievable entirely by online communication (or good old phone).
They might need a zoom conference or two (or three).
Any post-unblind communication between the company, statisticians, SAB's, steering committee etc. needs to be very secure, for obvious reasons.
Opinion.
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