Question: ArrayIf the situation described in the plan as "definitely relevant", "possibly relevant", or "unable to determine" is relevant, it will be considered as the PV of the CRO, Do you need to confirm with the applicant that 'possibly unrelated' situations are also relevant, and that meeting SUSAR standards also requires rapid reporting? @ @ According to Article 33 of China's Good Clinical Practice for Drug Trials, the applicant entrusts a contract research organization (CRO) When carrying out work, it is necessary to clarify the specific tasks entrusted and the corresponding standard operating procedures. Therefore, it is recommended that CRO communicate fully with the sponsor before the project is launched, reach an agreement on the criteria for correlation judgment and SUSAR reporting, and implement this standard uniformly in the research project. If there are exceptions, it is necessary to communicate fully with the applicant and researcher in a timely manner, and keep records of the relevant communication and discussion results as well as judgment criteria. There are currently different standards in the industry regarding whether 'possibly unrelated' should correspond to 'relevant'. For example, according to Clinical Trial Regulation (EU) No.536/2014 Q&A, if researchers use WHO's causal relationship classification, it may be considered irrelevant. According to the CDE's "Common Issues in Rapid Reporting of Safety Data during Drug Clinical Trials (Version 1.0)", Q9 mentions that causal relationships are "unable to be evaluated" or "unknown", which are not standardized, but cannot exclude correlations and require rapid reporting according to SUSAR. It is recommended that applicants establish internal procedures based on compliance and scientific considerations to standardize the evaluation criteria for causal relationships. Reference: Clinical Trial Regulation (EU) No.536/2014 Q&A, May 2022 Quick Report on Safety Data during Drug Clinical Trials FAQ (Version 1.0)