2018 Volume 8 Issue 3 Pages 165-177
Following the fraudulent incident of data manipulation and conflicts of interest arising in clinical research, compulsory legal regulation was introduced from April 1 in 2018 in place of conventional research ethics guidelines. Taking into consideration the balance with promoting clinical research, the Clinical Trials Act set minimum rules on the relationship between the four action entities (authorities, researchers, certified review boards, marketing authorization holders of medicines etc.) and planned to clarify the procedure of clinical research and improve the quality. The implementation of high quality clinical research depends on the performance of the certified review board. In order to utilize the results of high-quality clinical research, we would like to advance the environment to raise the reliability of clinical trials and carry out with the patients and society.
