The Common Problems and Countermeasures in the Process of Informed Consent of Drug Clinical Trials
Xie Jiangchuan, Wei Guo, Xie Linli, LI Ming-hong, Pan Xinmei, Cao Li-ya, Chen Yong-chuan
Abstract
Xie Jiangchuan, Wei Guo, Xie Linli, LI Ming-hong, Pan Xinmei, Cao Li-ya, Chen Yong-chuan
Abstract
Drug clinical trial is an important link to determine whether a new drug is safe and effective.Informed consent is an important document to protect the rights and interests of subjects in clinical trial.Based on its own work and combined with clinical trials projects,this paper discussed the problems existing in the signing of informed consent and analyzed the problems existing in the informed consent form and the problems that bidders,researchers,ethics committee and subjects should pay attention to when signing the informed consent form.To standardize and improve the problems of informed consent signing in order to contribute to the development of clinical trials.
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Drug clinical trial is an important link to determine whether a new drug is safe and effective.Informed consent is an important document to protect the rights and interests of subjects in clinical trial.Based on its own work and combined with clinical trials projects,this paper discussed the problems existing in the signing of informed consent and analyzed the problems existing in the informed consent form and the problems that bidders,researchers,ethics committee and subjects should pay attention to when signing the informed consent form.To standardize and improve the problems of informed consent signing in order to contribute to the development of clinical trials.
Key concepts: Informed consent, Clinical trial, Clinical research, Drug trial, Ethics committee, Medicine, Alternative medicine, Family medicine