GM1 ARA.MED.330 Special medical
circumstances
ED Decision 2016/008/R
GENERAL
(a) When the terms ‘medical assessment protocol’, ‘research protocol’ and
‘protocol’ (as mentioned in ARA.MED.330 and its associated AMC) are used,
they all refer to a ‘medical assessment protocol’.
(b) The protocol is to enable experience to be gained in special medical
circumstances in a controlled manner. This is to facilitate a better
understanding of the treatment or condition, so that an evidence-based
decision concerning its implementation may be considered.
(c) The protocol and its implementation should comply with the principles
described in the following publication of the World Medical Association (WMA):
“WMA Declaration of Helsinki - Ethical Principles for Medical Research
Involving Human Subjects”, as last amended.
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