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MHRA revises Phase I Accreditation Scheme 27/11/2013

Posted by Shirley Hallam in Approvals, Ethics.
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MHRAThe MHRA has updated the Phase I Clinical Trials Accreditation Scheme.  The voluntary scheme, which was introduced in the aftermath of the Te Genero incident in 2006, is designed to promote “best practice” procedures encompassing the highest standards for avoiding harm to trial participants and for handling medical emergencies.

The revision to the scheme puts in place a single level of accreditation, which has been extended to include academic units and patient volunteer trials.

Units that are not accredited are not excluded from conducting Phase I clinical trials, since the scheme is voluntary. However, sponsors are advised to take the absence of accreditation into account when considering the trial site and to consider conducting their own site inspection.