Abstract: Objective To describe the formulation process and checklist items of the Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE), and to advance our understanding and applications of the RIMES-SE checklist tool. Methods The background of updating the reporting standards for pharmaceutical risk minimization evaluation studies was summarized. Following a translation integrity procedure involving forward and backward translation steps, the translation of the RIMES-SE checklist was completed. An illustrative interpretation using the effective evaluation research of valproate risk minimization measures implemented in Europe was attempted. Results The RIMES-SE checklist was organized into two dimensions—risk minimization interventions and implementation strategies—comprising a total of 27 items. The reporting of the valproate risk minimization program was clear in structure and methodologically sound. However, the principles about implementation science, explicit definitions and threshold setting for effectiveness of risk minimization measures, and clarity regarding the extent to which interventions were delivered as intended to all participants needed to be improved. Conclusion With the progressive adoption of RIMES-SE by pharmacovigilance authorities worldwide, this reporting standard will provide an important framework to guide more rigorous and standardized pharmaceutical risk minimization evaluation studies in China.

Key words: Risk Minimization Evaluation Studies, RIMES-SE, Complex Intervention, Implementation Strategy, Effectiveness Evaluation, Reporting Statements