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European Pharmaceutical Contractor
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The most important factor in any research or clinical trial is patient safety. The quality of the research or trial must be consistent with good clinical practice, the principles of which have been internationally agreed in clinical trials. They aim to protect the rights, safety and wellbeing of patients and to uphold the ethical and quality standards for design, conduct and reporting of trials. There are various sources for such guidance, these are outlined in the reference and further reading list, and the ethical principles of the Declaration of Helsinki which are consistent with good clinical practice and applicable regulatory requirements.
The European Clinical Trials Directive aims to protect trial participants and to simplify and harmonise trials across Europe. In the UK an additional level of guidance is provided by the Research Governance Framework, which sets out broad principles of good research governance to ensure that health and social care research is conducted to high scientific and ethical standards. This article addresses the impact of some of the changes which the European Directive 2001/20/EC could bring in good regulation and legislation of clinical trials, served by working together to provide appropriate regulation, supervision and standards. This is the first of a series of three articles on clinical trials; the second one will cover preparing subjects/patients and informed consent for trials; and the third will cover risk management of trials.
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