There is a good website for the Medicines Regulations implications for studies that already have ethical approval at www.ct-toolkit.ac.uk
The R&D Forum has useful links www.rdforum.nhs.uk/ctregulations.htm
TROICA is the stimulus to the revision of the regulations as there is no time to get a Legal Representative to consent before the treatment has to be given.
Tim.
-----Original Message-----
From: Accident and Emergency Academic List
[mailto:[log in to unmask]]On Behalf Of Anton van Dellen
Sent: 08 February 2005 18:27
To: [log in to unmask]
Subject: thrombolysis
The TROICA study did indeed get ethical approval - unfortunately, that
does not remove the fact that it is not in accordance with the law as
currently framed - hopefully very soon to be rectified as notified.
Anton
Staffs
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