Time allowance windows? [Study Performance]
Dear Joy,
What I often see in protocols is that any time deviation of more than a certain value will be considered as a protocol deviation and will be reported as such in the study report. But all time deviations are reported and are considered in the PK analysis.
I have seen strange interpretations of such protocol provisions: allowed deviation ± 2 min, actual deviation + 5 min, reported deviation + 3 min...
I agree with Helmut: there is no reason why any sample should be collected early. Meaning that any sample collected early should be considered as a protocol deviation. After all, if a subject arrives late for an ambulatory sample there is little you can do; but if he arrives early you can ask him to wait. He was informed of the protocol constraints and agreed to them when signing the consent form.
What I often see in protocols is that any time deviation of more than a certain value will be considered as a protocol deviation and will be reported as such in the study report. But all time deviations are reported and are considered in the PK analysis.
I have seen strange interpretations of such protocol provisions: allowed deviation ± 2 min, actual deviation + 5 min, reported deviation + 3 min...
I agree with Helmut: there is no reason why any sample should be collected early. Meaning that any sample collected early should be considered as a protocol deviation. After all, if a subject arrives late for an ambulatory sample there is little you can do; but if he arrives early you can ask him to wait. He was informed of the protocol constraints and agreed to them when signing the consent form.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Acceptable deviation of blood sampling time joy_fm 2015-08-10 08:50
- 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