Discussion on the management of Suspected Unexpected Serious Adverse Reaction reports during clinical trials / 中华医学科研管理杂志

ABSTRACT

Objective:According to the new GCP regulations issued by national medical products administration, this paper discusses the management mode of Suspected Unexpected Serious Adverse Reaction (SUSAR) reports during clinical trials.Methods:Combined with GCP regulations and working practice, this paper comprehensively analyzes the issues identified and related reasons for the management of SUSAR reports during clinical trials, and propose possible countermeasures.Results:There are some problems in the management of SUSAR reports among different stakeholders during clinical trials, such as defects in the performance of obligations and responsibilities. It is suggested that investigators should be more carefully to fulfill GCP responsibilities; sponsors should be more accurately implement the reporting procedures; institutional and ethical supervision should also be strengthened to assure better conduct of clinical trials.Conclusions:Multi-party collaboration and management mode play crucial roles in conducting high-quality clinical trials.