Answer： The IIT of pre market drugs is currently mainly divided into two categories: firstly, the experimental drug is approved by the national drug regulatory department for clinical trials, and the researcher initiates other clinical trials related to this experimental drug. In this case, the applicant remains the responsible subject, and for SUSAR occurring in IIT, it belongs to "other sources", Rapid reporting is required as required; Secondly, the experimental drug has not been reviewed and approved by the national drug regulatory department, and is only conducted spontaneously by the researcher. It is mostly reviewed and approved by the academic professional committee and ethics committee of the researcher's institution, and there is no registration acceptance number. Therefore, in this case, SUSAR does not need to be quickly reported to the drug review center The sponsor/drug provider needs to sign a safety data exchange agreement with the researcher to specify the type and method of reporting safety data to the sponsor/drug provider, in order to ensure compliance with the submission requirements of national drug regulatory authorities and continuous monitoring of drug safety. Reference: "Common issues and recommendations for rapid reporting of suspicious and unexpected serious adverse reactions during drug clinical trials in China", Journal of Chinese Pharmacovigilance, Volume 19, Issue 2 (182 of the total), pp. 176-179.