Thanks CT. I started at the newest messages on thi
Post# of 153884
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Posted On: 01/26/2021 9:28:51 PM
Thanks CT. I started at the newest messages on this discussion
It does seem reasonable to me that patient file audits should take a week.
It does seem even longer if the auditor is requesting the trial site investigators provide missing data. Probably each request like that takes at least 24 hours to clear.
It also seems reasonable to me that the auditor must be blinded while this sort of patient medical record review is taking place.
If Amarex has only one primary auditor, who works through each and every patient file, then it does seem like it could take at least a week for one individual to work through 390 patient files, even if the auditor has gophers he can use every time he develops an issue. Even if there are two primary auditors probably they each review all 390 patients just to get some error prevention.
I suppose that careful review of the data by the still blinded auditor could also include careful setup of spreadsheets and calculators that contain all information except placebo vs. treatment, and that when all the auditing is finished, the endpoint results are quickly available because the calculations are fully set up and just waiting for the placebo vs. treatment plugin.
It does seem reasonable to me that patient file audits should take a week.
It does seem even longer if the auditor is requesting the trial site investigators provide missing data. Probably each request like that takes at least 24 hours to clear.
It also seems reasonable to me that the auditor must be blinded while this sort of patient medical record review is taking place.
If Amarex has only one primary auditor, who works through each and every patient file, then it does seem like it could take at least a week for one individual to work through 390 patient files, even if the auditor has gophers he can use every time he develops an issue. Even if there are two primary auditors probably they each review all 390 patients just to get some error prevention.
I suppose that careful review of the data by the still blinded auditor could also include careful setup of spreadsheets and calculators that contain all information except placebo vs. treatment, and that when all the auditing is finished, the endpoint results are quickly available because the calculations are fully set up and just waiting for the placebo vs. treatment plugin.
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