Conduct of Clinical Trials/Research
Recommendations guiding medical doctors in biomedical research involving human subjects are contained in the Declaration of Helsinki, adopted by the World Medical Assembly in Helsinki in 1964, and updated subsequently.
Originally introduced in connection with pharmaceutical company trials the principles of Good Clinical Practice have now been adopted (to a greater or lesser degree) by all conducting clinical trials (ie both pharmaceutical companies and academia). The EU Directive on GCP in Clinical Trials, aimed at standardising trial conduct throughout Europe and effective from lst May 2004, brings an increasing level of regulatory requirements to the conduct of clinical trials, and represents the biggest single challenge faced by those working in the area of clinical trials.
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