Clinical Trials Directive

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Clinical Trials Directive

The Clinical Trials Directive (klin-i-kal try-als di-rek-tiv) is a piece of legislation that was implemented by the European Union (EU) to regulate the conduct of clinical trials across its member states.

Etymology

The term "Clinical Trials Directive" is derived from its purpose. "Clinical trials" refers to the scientific studies conducted to find better ways to prevent, screen for, diagnose, or treat diseases. "Directive" is a legal term used in the EU to denote a legislative act that sets out a goal that all EU countries must achieve.

Definition

The Clinical Trials Directive, officially known as Directive 2001/20/EC, was adopted in April 2001. Its main objective is to ensure the protection of human health during the conduct of clinical trials. It sets out the procedures for the authorization of clinical trials, the responsibilities of the sponsor, the protection of clinical trial subjects, and the quality and safety of investigational medicinal products.

Related Terms

  • Clinical trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects on health outcomes.
  • Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.
  • Investigational Medicinal Product (IMP): A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial.
  • Directive 2001/20/EC: The official name of the Clinical Trials Directive.

See Also

External links

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