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Posted On: 01/27/2021 1:03:05 PM
Post# of 154090
Re: Borel Fields #74575
thanks borel.
ok so seven point ordinal scale has four entreis for each patient (days 0 14 28 42)
sofa score has fourteen more entries for each patient.
i dont think the entry for leronlimab yes or no is included at this point. probably the auditor is supposed to be blinded to that while the auditor suses all the rest ouf of the data.
presumably each set of patient records comes with a scoresheet for the trial, and then the auditor has to check the scoresheet to make sure all 18 entries for each patient are correct.
the patient records are probably in electronic format. if paper the audit could take a month.
a one month hospital stay generates at least five hundred pages of data I suspect. and each hospital has different formatting.
So for a single entry, the auditor has to search around for some key terms and make sure that everything is correct. he/she will work carefully on each entry.
I would not be surprised at three minutes for each entry.
390*18*3= 21,060 minutes = 351 hours
that seems like a lot. but the fda must have a protocol that describes the quality control (and auditing?) on the data. maybe amarex has a lot of people working on the audit?
ok so seven point ordinal scale has four entreis for each patient (days 0 14 28 42)
sofa score has fourteen more entries for each patient.
i dont think the entry for leronlimab yes or no is included at this point. probably the auditor is supposed to be blinded to that while the auditor suses all the rest ouf of the data.
presumably each set of patient records comes with a scoresheet for the trial, and then the auditor has to check the scoresheet to make sure all 18 entries for each patient are correct.
the patient records are probably in electronic format. if paper the audit could take a month.
a one month hospital stay generates at least five hundred pages of data I suspect. and each hospital has different formatting.
So for a single entry, the auditor has to search around for some key terms and make sure that everything is correct. he/she will work carefully on each entry.
I would not be surprised at three minutes for each entry.
390*18*3= 21,060 minutes = 351 hours
that seems like a lot. but the fda must have a protocol that describes the quality control (and auditing?) on the data. maybe amarex has a lot of people working on the audit?
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