GVP – Module XVI Addendum II: Methods for evaluating effectiveness of risk minimisation measures

In force from: 6. 8. 2024

MODULE - FULL TEXT

MODULE - DETAILS

XVI.Add.II.1. Introduction

XVI.Add.II.2. Data sources

XVI.Add.II.2.1. Data sources for qualitative research

XVI.Add.II.2.2. Surveys

XVI.Add.II.2.3. Registries

XVI.Add.II.2.4. Medical records

XVI.Add.II.2.5. Administrative claims

XVI.Add.II.2.6. Healthcare record linkage

XVI.Add.II.2.7. Spontaneous reporting systems

XVI.Add.II.2.8. Factors influencing the choice of data source(s)

XVI.Add.II.3. Research methods

XVI.Add.II.3.1. Qualitative methods

XVI.Add.II.3.2. Survey methods

XVI.Add.II.3.3. Pharmacoepidemiological methods

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

XVI.Add.II.4.1. Study registration

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