XVI.Add.II.4. Reporting on RMM effectiveness studies

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XVI.Add.II.

XVI.Add.II.4.1. Study registration

All non-interventional studies evaluating the effectiveness of RMM should be a priori registered in the HMA-EMA Catalogue of Real-World Data Studies11 . As for all non-interventional postauthorisation safety studies (PASS), the requirements for study reports, reporting of adverse reactions/events and data relevant to the risk-benefit balance of the studied medicinal product apply and should be reported by the organisation responsible for the conduct of the study in line with the requirements of GVP Module VIII.

XVI.Add.II.4.2. Checklist for harmonised reporting of study results

Established reporting standards such as the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) Statement12 may have limited effects on the reporting quality of studies evaluating RMM effectiveness (while being appropriate for other purposes). This is because these standards focus on single study designs without addressing the underlying rationale and critical factors relevant to the implementation of health interventions such as RMM in healthcare contexts. The recent Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE) 13 , tailored to study designs frequently used for RMM evaluation (42), should be used to standardise reporting of the results of such studies. Reporting items have been derived from the RIMES-SE standard for reporting results of RMM effectiveness studies (see Table XVI.App.II.1., RIMES-SE items are marked by #), to facilitate the completion of the final report in the format described in GVP Module VIII.

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