Are there any restrictions on the qualifications of the trial investigators of clinical trials?

刊登日期:2019-11-11  |  點閱次數 : 925 次 

According to Article 4 of the Regulations on Human Trials, the trial conductor referred to in the preceding article shall possess the following qualifications:

I. Being a licensed physician, dentist, or traditional Chinese medicine physician with five or more years of experience in clinical practice.

II. Having received human trial related training of more than thirty hours within the past six years; being the investigators in Human Trials of somatic cells or gene therapy with additional five or more hours of relevant training.

III. Taking medical ethics related courses for more than nine hours within the past six years..

Those who have been subject to physician disciplinary or whose licenses have been suspended for more than one month or abolished due to any violation of laws and regulations related to Human Trials shall not serve as an investigator.



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