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criskorea@korea.kr

FAQ

FAQ
Question What clinical study needs to be registered?
Type General
Answer

Any clinical study which will be conducted with human participants in Korea, aiming to prevent, detect, diagnose or treat diseases, can be registered. Therefore, observational study can be registered as well as interventional study. It is highly recommended to register a clinical study prior to the first subject´s enrollment. However, we currently accept the clinical study which has been already completed or is being conducted.

In Korea, the registration of clinical study is not legally required, but recommended.

If a clinical study is funded by Ministry of Health and Welfare and its affiliates such as Korea Centers for Disease Control and Prevention, however, it should be registered with the CRIS based on [the Regulation for Management of Health and Medical Technology R&D Projects] since February 2012.

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Next How do I register a clinical study with the CRIS? 2015.08.11
Previous What information is entered into the CRIS? 2015.08.11