Time allowance windows? [Study Performance]
Hi Helmut,
thank you for your reply.
We have removed “magic” time allowance window (TAW) from our protocol. So every blood sampling deviation, will be reported in CRF and statistical analysis.
But one of our customer, ask us, to put TAW in our protocol. Since we can't justify the deviation, we can't accept the request. What I know from training, TAW will be specific for any kind of drug molecules, it can't 5%, more or less, depend on the impact to pharmacokinetic analysis.
But we don't how to decide the percentage of blood sampling deviation which can't make an effect to pharmacokintetic analysis.
Would you mind to share how to decide the percentage of blood sampling which can't categorize as deviation, so TAW won't be "magic" again, but scientifically sound.
Thank you
joy_fm
thank you for your reply.
We have removed “magic” time allowance window (TAW) from our protocol. So every blood sampling deviation, will be reported in CRF and statistical analysis.
But one of our customer, ask us, to put TAW in our protocol. Since we can't justify the deviation, we can't accept the request. What I know from training, TAW will be specific for any kind of drug molecules, it can't 5%, more or less, depend on the impact to pharmacokinetic analysis.
But we don't how to decide the percentage of blood sampling deviation which can't make an effect to pharmacokintetic analysis.
Would you mind to share how to decide the percentage of blood sampling which can't categorize as deviation, so TAW won't be "magic" again, but scientifically sound.
Thank you
joy_fm
Complete thread:
- Acceptable deviation of blood sampling time joy_fm 2015-08-10 08:50 [Study Performance]
- Time allowance windows? Helmut 2015-08-11 00:44
- Time allowance windows?joy_fm 2015-08-11 04:07
- Actual vs. scheduled times Helmut 2015-08-11 13:09
- Actual vs. scheduled times joy_fm 2015-08-13 19:00
- Time allowance windows? Ohlbe 2015-08-17 17:51
- Actual vs. scheduled times Helmut 2015-08-11 13:09
- Time allowance windows?joy_fm 2015-08-11 04:07
- Time allowance windows? Helmut 2015-08-11 00:44