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RegisterI thought I have seen everything [Study Assessment]
Hi Helmut!
4 out of 30 subjects had this fiasco. Get this one --> Sampling time at 3.5 and 4.0 hour... They were late 35 mins for the 3.5 (meaning it crossed over into the 4 hr timepoint). They then draw a 4 hr timepint sample with a delay of 11 mins (It's obvious why, they didn't want to miss collecting a sample!!!)So now I have a 3.5hr sample with a +35min deviation and a 4 hr with a +11min deviation!!! what should I use for PAUC0-4??????
Reason for deviation? Couldn't get blood from sites of puncture! 35mins!???? how many time did they poke on the subjects arm(s)!!!!!
I wouldn't have gone ballistic if the reason was "Subject went into hiding somewhere in the dosing area"
❝ ❝ […] Tada, some CRO managed to screw up some early timepoint collection by as much as 35mins!
❝
❝ That’s a fucking lot! What happened? Normaly time deviations outside an “allowance window” stated in the protocol must be not only documented as such but also a comment in the CRF should be given justifiying the event. 35min?!
4 out of 30 subjects had this fiasco. Get this one --> Sampling time at 3.5 and 4.0 hour... They were late 35 mins for the 3.5 (meaning it crossed over into the 4 hr timepoint). They then draw a 4 hr timepint sample with a delay of 11 mins (It's obvious why, they didn't want to miss collecting a sample!!!)So now I have a 3.5hr sample with a +35min deviation and a 4 hr with a +11min deviation!!! what should I use for PAUC0-4??????
Reason for deviation? Couldn't get blood from sites of puncture! 35mins!???? how many time did they poke on the subjects arm(s)!!!!!
I wouldn't have gone ballistic if the reason was "Subject went into hiding somewhere in the dosing area"
Complete thread:
- I thought I have seen everything jag009 2013-08-19 20:40 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- I thought I have seen everything Helmut 2013-08-20 15:43
- I thought I have seen everythingjag009 2013-08-20 18:09
- Gimme some data! Helmut 2013-08-20 18:16
- Gimme some data! jag009 2013-08-20 18:19
- Gimme some data! Helmut 2013-08-20 18:34
- Gimme some data! jag009 2013-08-20 19:54
- Gimme some data! Helmut 2013-08-20 18:34
- Gimme some data! jag009 2013-08-20 18:19
- Gimme some data! Helmut 2013-08-20 18:16
- I thought I have seen everythingjag009 2013-08-20 18:09
- I thought I have seen everything Helmut 2013-08-20 15:43
Ing. Helmut Schütz