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Posted On: 07/18/2020 5:41:56 PM
Post# of 148903
I'll admit it's been a couple decades, but,
Among the major services Amarex is supplying is an FDA-compliant data system. They have computer-operated bookcases where all the original documents sent in from the trial sites are stored. Those docs are also all scanned into a document management system that feeds forward into the analytical data sets and backwards to the physical documents. The FDA can drop in on no notice and ask them to trace back from any number in any sheet to the source document.
The data set isn't locked until they are sure they can meet those inquiries, and it's not unblinded until after it is locked.
As Sunclouds notes, the detail of the statistical analysis plan is 100% documented before the trial is approved. That even includes the criteria for the DSMB.
The code that runs the analyses is also FDA audited, though that might not have happened yet. There is no way 100% of the statistical analysis software was not written and verified before the data became available. Running it takes no time.
Among the major services Amarex is supplying is an FDA-compliant data system. They have computer-operated bookcases where all the original documents sent in from the trial sites are stored. Those docs are also all scanned into a document management system that feeds forward into the analytical data sets and backwards to the physical documents. The FDA can drop in on no notice and ask them to trace back from any number in any sheet to the source document.
The data set isn't locked until they are sure they can meet those inquiries, and it's not unblinded until after it is locked.
As Sunclouds notes, the detail of the statistical analysis plan is 100% documented before the trial is approved. That even includes the criteria for the DSMB.
The code that runs the analyses is also FDA audited, though that might not have happened yet. There is no way 100% of the statistical analysis software was not written and verified before the data became available. Running it takes no time.
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