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Re: Millstone post# 98084

Friday, 07/24/2020 4:16:07 PM

Friday, July 24, 2020 4:16:07 PM

Post# of 232977
Millstone..All the data HAS to be collected..before unblinding.. The Principal Investigator from each site has to sign off.. validating it..

If now Site A does not record a pulse for Day7.. The Sponsor has to issue a query.. The site coordinator answers the query.. The PI signs off of it.. NOW the pulse can be tabulated . By the Statistician.. Consider now the hundreds to thousands of queries being issued .. Patient A name is John Doe.. However you’ve entered JKD.. Please clarify.. and on and on..

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