EU Clinical Trials Directive: Effects on clinical research

The European Union (EU) Directive 2001/20/EC (commonly referred to as the Clinical Trials Directive) outlines new procedures for conducting trials involving medicinal products in human subjects (healthy volunteers and patients). In this white paper, Fulcrum Pharma Developments Inc. outlines the main objectives of the Clinical Trials Directives and how research companies and institutions undertaking clinical research will be affected. It also reviews how to respond to the new regulations so that clinical trials can be performed in the most cost- and time-effective manner.

The new regulations of the EU Clinical Trials Directive will impact all major aspects of the clinical trial process and affect anyone performing research involving human subjects. This includes pharmaceutical and biotechnology companies, charities, research institutes, hospitals, and academic departments. A primary objective of the Directive is to protect clinical trial participants, regardless of the organization that is conducting or funding the study. Clinical trials will require a sponsor who will assume legal responsibility for all aspects of the clinical research.

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