International standards for conducting trials

Clinical trials should be conducted in accordance with the principles set out in the International Conference on Harmonization's Good Clinical Practice (ICH GCP) Guideline. This guideline defines GCP as: 'A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.' The ICH GCP guideline was developed to provide a unified standard for the European Union, Japan and the US in order to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. It was developed in accordance with the current GCP of the countries involved and of Australia, Canada, the Nordic countries and the World Health Organization. It is primarily concerned, however, with the development of new, investigational, medicinal products. In the UK, the British Medical Research Council, in consultation with the National Health Service Research and Development Programme, has therefore published guidelines, based on the ICH GCP principles but adapting the guideline for more general application, intended to be of use as a practical handbook to any engaged in conducting clinical trials ( [1].

The list of publications and web sites shown in Box 7.2 should prove useful for reference purposes.

These documents define the individuals and groups involved in conducting trials and list their roles and responsibilities. They also make recommendations on protocol design; statistical matters; trial coordination and monitoring; data collection, verification and handling; and ethical issues. The COREC web site is a useful route to other relevant sites.

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