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Posted On: 01/10/2021 6:42:31 PM
Post# of 154851
Re: reallypeople? #72104
reallypeople?
The poster is Science + Compliance
He recently added the following:
I have worked on the Sponsor side for about 30 yrs (and currently do today). I've also done about 50 CRO audits, so I understand their processes pretty well. I think some may be misinterpreting what I'm saying. The subjects are still blinded, but by looking at the lab data one could make a determination what arm they were in. This is an output of a well designed trial as well as drug product characterization.
If any data were unblinded it would be a study deviation that would be critical in nature and would have more severe impact.
The poster is Science + Compliance
He recently added the following:
I have worked on the Sponsor side for about 30 yrs (and currently do today). I've also done about 50 CRO audits, so I understand their processes pretty well. I think some may be misinterpreting what I'm saying. The subjects are still blinded, but by looking at the lab data one could make a determination what arm they were in. This is an output of a well designed trial as well as drug product characterization.
If any data were unblinded it would be a study deviation that would be critical in nature and would have more severe impact.
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