Question: ArrayIf a clinical trial protocol requires more than 6 visits, a subject will upgrade the protocol to version 2.0 upon completion of V2, and the informed consent form of our center will be upgraded to version 2.0 and obtain ethical approval. The researchers and participants were informed according to the content of the 2.0 version of the informed consent form, but the participants stated that they need to consider before deciding whether to agree. This informed consent process is properly recorded in the original records. During V3 and V4, the subjects stated that they were still considering it because they did not sign the informed consent form. Therefore, the operations of V3 and V4 continued to follow the 1.0 version protocol. After the end of V4, the subjects only signed the 2.0 version informed consent form. So, does the subject need to report protocol violations for treatment during V3 and V4