RT Journal Article
SR Electronic
T1 Academic clinical research in the new regulatory environment
JF Clinical Medicine
JO Clin Med
FD Royal College of Physicians
SP 39
OP 41
DO 10.7861/clinmedicine.5-1-39
VO 5
IS 1
A1 Brian Gennery
YR 2005
UL http://www.rcpjournals.org/content/5/1/39.abstract
AB As a result of European legislation passed in 2001 (Directive 2001/20/EC), all clinical trials, whether sponsored by industry, a major national body or charity, or done by a single academic investigator, must get approval from the Medicines and Healthcare products Regulatory Agency (MHRA) as well as obtaining ethical approval. This requires all studies to be carried out to the standards of ‘Good Clinical Practice’ and places burdens on investigators in terms of reporting adverse events and archiving. A new directive has been published in draft form that will finally define what is meant by Good Clinical Practice in Europe.