A sponsor wishing to conduct clinical studies with an investigational drug in the European Union must seek and gain approval before each phase of clinical development. This entails submitting a Clinical Trial Authorisation (CTA) application to the regulatory Competent Authority of each Member State (MS) in which the clinical trial is to be conducted.

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The pharmaceutical industry is undergoing many regulatory changes. Those of us involved in research are directly affected. When carrying out our duties there is a risk of compromising the quality of data we generate and of breaching ethical codes. An understanding of the background and the principles of Good Clinical Practice are critical to ensure ethical research, high quality and credible data.

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Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials.

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India has been identified as an increasingly attractive country for conducting clinical trials and providing data management services. With its large patient population, well-trained investigators and considerably lower trial costs than in developed nations, India has gained wide recognition as a country capable of offering opportunities for conducting clinical trials.

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The purpose of site evaluation and set-up is to ensure that the site has access to the required patient population, has appropriately qualified staff, adequate time and facilities to conduct the study and to ensure the site is fully prepared for the conduct of the clinical trial.

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This module provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials.

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Once a trial is initiated, the crucial role of the clinical research associate (CRA) is to monitor the conduct of the trial and the integrity of the data recorded.

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Clinical trial sites of sponsors and investigators are subject to rigorous inspection by regulatory agencies to ensure compliance with Good Clinical Practice (GCP). Auditing assures the agency (and the sponsor) that good standards are being maintained and that the sites are fit for undertaking clinical research studies.

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