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Year : 2015  |  Volume : 2  |  Issue : 1  |  Page : 4-8

Quality in clinical research activities: Role of institution/clinical trial site

Department of Medicine, JSS Medical College, Mysore, Karnataka, India

Correspondence Address:
Dr. Pratibha Pereira
38/D, 2nd Cross, Krishna Jayalaxmipuram, Mysore, Karnataka
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2319-1880.160232

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There is an increasing focus on having quality systems in place during the planning stages of clinical trials. Such systems require the development and implementation of standards for each step. Although this is not imposing something totally new on clinical research, a systematic approach will produce a more reliable and useful end product-high-quality data obtained without compromising the protection of human subjects' rights and welfare. A suggested quality system with standards for each step is addressed in this article. The organization measures and improves when necessary, compliance with organizational policies, procedures, and applicable laws; regulations, codes, and guidance. The organization also measures and improves when necessary, the quality, effectiveness, and efficiency of the clinical trial process to protect the research participant.

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