Abstract
Important matters allowing medical investigators to adequately perform clinical trials are described.
Clinical trials can provide abundant and clinically important information concerning the efficacy, safety, and pharmacokinetics or pharmacodynamics （PK/PD） of drugs, which are essential for adequate medical treatment. However, for subjects, clinical trials occasionally produce adverse events or present ethical problems. Therefore, investigators should be qualified by education, training, and experience to assume responsibility for properly conducting trials. To ensure scientific data reliability and protect subjects from all clinical trial risks, investigators must follow certain regulations, including the GCP or Ethical Guidance for Clinical Research, as well as the Declaration of Helsinki. Furthermore, all investigators, following the Act on the Protection of Personal Information or other ethical guidelines related to research, must protect the personal information of subjects. The independent ethics committee and the institutional review board serve very important roles in the appropriate performance of clinical trials by reviewing protocols and informed consent documents. Last, the investigators are required to understand how a clinical trial should be carried out in terms of the health insurance system.
Keep in mind that qualified investigators can accomplish socially appraised and valuable clinical research.
