| Good Clinical Practice in Neonatal Clinical Research. |
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Min Soo Park |
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Director, Clinical Trials Center/Head, Department of Clinical Pharmacology, Severance Hospital, Yonsei University Health System, Korea. neoclipha@yuhs.ac, minspark@yuhs.ac |
| 신생아 임상연구에서의 Good Clinical Practice |
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| Abstract |
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Clinical research is a necessity, not an option, for developing better and new medicines and therapeutic modalities. But in the course of clinical research, there are rules and guidelines that should be followed to ensure the due respect for persons, beneficence, and justice for persons who voluntarily participate in the research as described in the Belmont Report. Good Clinical Practice (GCP) is an "international scientific and ethical quality standard for designing, conducting, recording, and reporting" clinical trials. The main purposes of GCP would be to protect rights, safety, and well-being of trial subjects, in compliance with the principles of Declaration of Helsinki, and to assure that the data obtained from clinical trials are credible. In order to achieve these, investigators must be fully aware of the meanings as well as actual procedures involved in the research and should make the best effort to comply with GCP. For those individuals who belong to vulnerable populations, such as neonates, in addition to the general principles of GCP, further measures to ensure added protection should be implemented. It is our duty to develop and provide better care through clinical research even for neonates. But in doing so, we have to make sure that the importance of protecting the rights, safety, and well-being of the subjects supersede the interests of science and society. |
| Key Words:
Good clinical practice (GCP); Clinical research; Clinical trials; Declaration of Helsinki; Belmont report; Neonates |
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