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Recent articles in the BMJ on the implications of the
EU Directive on Clinical Trials have not yet discussed one important point
: Once the EU Directive is
incorporated into UK legislation (and who knows just when that may be), it
will be a criminal offence to conduct a clinical trial which is not GCP-
compliant. This will apply to all clinical trials, including academic and
Those who subscribe to the popular beliefs that
(a) GCP refers to clinical practice and is something to do with clinical
(b) GCP will only ever apply to industry-sponsored research,
should do their homework.
The lawyers will certainly be doing theirs.