Clinical trial? According to ICH-GCP definition yes! [Off Topic]
❝ Out of interest, Caffeine is released and available, so this isn't a clinical trial, but what regulations do apply ?
Dear Paul
According to ICH-GCP a clinical trial is any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining ist safety and/or efficacy.
IMHO the students were treated with a drug (coffeine as pure drug and not as cup of coffee) and nobody thought about the consequences neither for the students nor for themselves.
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Students given 30g dose of Caffeine in Sports study paulhurleyuk 2017-01-26 11:04 [Off Topic]
- Clinical trial? According to ICH-GCP definition yes!Dr_Dan 2017-01-31 08:42