This is how I spent my lovely Friday morning (8/2). I received some DCFs for a 2005 trial. Let me put it this way, to say they are outrageous is an undeserved compliment. Ok, one of them goes like this:
“Item: Platelets = 95 10^3/mcl
Problem: corresponding LNR 050302 (eff.31JAN2004)
Comment: LAB: Platelet(08MAR2007) is outside the corresponding LNR 140 – 415 10^3/mcl and represents a violation of the inclusion/exclusion criteria. Please check & verify result, and provide comment.”
It certainly looks like a protocol violation. But why did it take 6 years for them to find it out?
(1) Get the CRF binder and patient chart to confirm the platelet value done on 3/8/2007 is correct.
(2) Get the protocol, and read the inclusion/exclusion criteria to confirm value 95 is out of the accepted range for enrolment.
(3) Check if there was other CBC lab done during that period. Check physician order and lab reports. Yes, one was done on 3/1/2007, with acceptable platelet value.
(4) Search protocol to see if the 3/1/2007 lab is within the timeframe to meet screening requirements.
(5) Patient consent on 4/5/2007 and was registered on 4/23/2007. The 3/1/2007 lab is out of the window.
(6) Check to see if patient had any medical activities during that period. Found patient went to have a surgery in late March 2007.
(7) Call the hospital to see if patient had any labs done while at the hospital.
(8) Faxed a formal request form to the hospital, as I was told.
(9) Follow up with the hospital later and
(10) Have to constantly keep related persons updated
No ending yet. Wait for their response and go from there.
It would be an easy solution if I admitted and submitted a protocol violation, but a violation is a major offense which we try to avoid.
I was in a bad mood after going through these actions, as I don’t like wasting my time cleaning up the mess left by others years ago. I lament greatly the loss of my time over one simple idiotic mistake that other people made. There is no word that can satisfactorily describe what upset I was on that day.
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