In the clinical trial dossiers of in vitro diagnostic reagents, the implementation plan of the clinical trial and the corresponding written comments of the ethics committee agreeing to carry out the clinical trial shall be submitted. Due to the change of clinical trial protocol, there may be multiple versions. The following principles should be noted when submitting application dossiers:
If the the clinical trial protocol changes before the formal implementation of the clinical trial, the clinical trial protocol of the final version shall be submitted, together with the written comments of the ethics committee corresponding to the version.If the clinical trial has started and the protocol is changed in the process, the clinical protocol before and after the change and its ethics documents shall be submitted together, and the reasons for the protocol change and its impact on the conducted clinical trial shall be clearly explained.It should be noted that before the clinical trial, the scientificity, rationality, feasibility and compliance of the protocol should be fully studied, the protocol should be formulated and strictly implemented. During the clinical trial, the protocol shall not be changed at will for unnecessary reasons.
