The standard clarifies the pre-clinical trial preparations, the protection of the rights and interests of subjects, the clinical trial protocol, the responsibilities of the ethics committee, the responsibilities of the sponsor, the responsibilities of the clinical trial institution and the investigators, records and reports, the management of experimental medical devices, and the management of basic documents.
According to the specification, medical device clinical trial refers to the process of confirming or verifying the safety and effectiveness of the medical device to be registered under normal conditions of use in an accredited medical device clinical trial institution; the principle of law , ethical principles and scientific principles shall be followed..
The CFDA pointed out that obtaining valid data through clinical trials is one of the important ways to evaluate whether medical devices are safe and effective. Standardize the responsibilities of clinical trial sponsors, clinical trial institutions and investigators, and clinical trial regulatory authorities according to the actual situation in China, referring to relevant international standards and foreign advanced management experience, and emphasizing the sponsor's management responsibility for clinical trials. , Refine the responsibilities and obligations of clinical trial institutions and investigators.
In order to strengthen the protection of the rights and interests of the subjects, the standard proposes that before the subjects participate in the clinical trial, the investigator shall fully explain the details of the clinical trial to the guardians of the subjects or persons without or with limited capacity of civil conduct , including known and foreseeable risks and possible adverse events, etc. The sponsor shall bear the cost of treatment and corresponding financial compensation for the subjects who suffer from trial-related injury or death.
In terms of strict risk management of clinical trials, the standard clarifies the risk control of the whole process of clinical trials and the mechanism of suspension and termination of clinical trials. By implementing the main responsibility of the sponsor, the safety and controllability of the clinical trial process is guaranteed.
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