Preliminary study of risk management mode for investigator-initiated clinical trials / 中华医学科研管理杂志

ABSTRACT

Objective To explore the risk management model of investigator-initiated clinical trials (IITs) from the prospective of clinical research management personnel,to provide further reference for its construction and implementation in China.Methods The risks in IITs and its current situation of risk management were analyzed.Risk management standards including ISO 31000 and related guidelines were adopted to explore the risk management mode for China-based IIT.Results This article proposed the new risk management mode for IITs and also introduced the specified frame and procedures of related risk management.Conclusions The risk management model proposed in this article provided reference for clinical research management.