Interpretations of reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES) statement

doi:10.19803/j.1672-8629.20220527

Abstract

Abstract: Objective To help implementers and readers better understand and apply the reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES) statements by introducing the checklist of RIMES statements and interpreting them. Methods The characteristics and current research of RIMES were summarized. Meanwhile, the checklist of RIMES statements was translated based on the translation integrity procedure (TIP) through forward and backward translation. Results There were 43 items in the RIMES checklist in four dimensions, including key information, research design, implementation and evaluation. Conclusion With the increasing regulators of global pharmacovigilance, RIMES statements will provide an important framework for RIMES.

Key words: Pharmaceutical Risk Minimization Evaluation Studies(RIMES), complex intervention, effectiveness evaluation, statement

CLC Number:

R951
R994.11

NIE Xiaolu, TANG Shaowen, YU Jinyang, SONG Haibo, FU Zhu, SUN Feng. Interpretations of reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES) statement[J]. Chinese Journal of Pharmacovigilance, 2023, 20(5): 524-529.

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