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RegisterStick to the protocol, but… [Design Issues]
posted by Helmut 
– Vienna, Austria, 2014-12-18 15:02 (4205 d 10:17 ago) – Posting: # 14109
Views: 16,014
Hi cher0424,
The former. Other re-tests are common.
Formally yes. Whether you want a volunteer on TCAs in the study is another question. Common sense: Given the side-effects of TCAs I don’t think that the subject took them for fun. I guess the pre-study exam contains a complete anamnesis (including neurologic or psychiatric illness, prior/present medication & therapy). Maybe he/she lied? Even if there are no interactions possible with the study’s drug, I would exclude the subject.
If the subject will jump out of the window in a suicidal episode, would the PI keep him/her in the study only because this was not foreseen as one of the exclusion criteria in the protocol?
❝ You mean no retesting in drug abuse or other clinic exam also?
The former. Other re-tests are common.
❝ TCA isn't listed in protocol, but can be test out in our drug abuse test card. So here is a pratical operated problem. The protocol writer didn't combine the reality with protocol. So all the things just refer to the protocol, then ignore the positive result of TCA?
Formally yes. Whether you want a volunteer on TCAs in the study is another question. Common sense: Given the side-effects of TCAs I don’t think that the subject took them for fun. I guess the pre-study exam contains a complete anamnesis (including neurologic or psychiatric illness, prior/present medication & therapy). Maybe he/she lied? Even if there are no interactions possible with the study’s drug, I would exclude the subject.
If the subject will jump out of the window in a suicidal episode, would the PI keep him/her in the study only because this was not foreseen as one of the exclusion criteria in the protocol?
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- BE study inclusion & exclusion criteria cher0424 2014-12-16 01:30
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study inclusion & exclusion criteria Helmut 2014-12-16 14:53
- BE study inclusion & exclusion criteria Ohlbe 2014-12-16 17:29
- BE study inclusion & exclusion criteria cher0424 2014-12-17 02:19
- Drugs of abuse Helmut 2014-12-17 14:42
- Drugs of abuse cher0424 2014-12-18 04:54
- Stick to the protocol, but…Helmut 2014-12-18 14:02
- Drugs of abuse cher0424 2014-12-18 04:54
- Drugs of abuse Helmut 2014-12-17 14:42
- BE study inclusion & exclusion criteria Helmut 2014-12-17 13:33
- BE study inclusion & exclusion criteria cher0424 2014-12-17 02:19
- BE study inclusion & exclusion criteria cher0424 2014-12-17 02:02
- BE study inclusion & exclusion criteria Helmut 2014-12-17 14:24
- BE study inclusion & exclusion criteria Ohlbe 2014-12-16 17:29
- BE study inclusion & exclusion criteria Ohlbe 2014-12-17 17:35
- BE study inclusion & exclusion criteria Helmut 2014-12-16 14:53
Ing. Helmut Schütz