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ENCePP Guide on Methodological Standards in Pharmacoepidemiology


13.4. Quality management in observational studies

Quality management principles applicable to observational studies with primary data collection or secondary use of data are described in the Commission Implementing Regulation (EU) No 520/2012GVP Module IFDA’s Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Health Care Data Sets, in recommendations from scientific societies such as the ISPE Guidelines for Good Pharmacoepidemiology Practices or the Guidelines and recommendations for ensuring Good Epidemiological Practice (GEP): a guideline developed by the German Society for Epidemiology (Eur J Epidemiol. 2019;34(3):301-17), and in general epidemiology textbooks cited in the Introduction of this Guide. The Strengthening the Reporting of Observational studies in Epidemiology (STROBE) Statement Guidelines for reporting observational studies has established recommendations for improving the quality of reporting of observational studies and seeks to ensure a clear presentation of what was planned, done, and found.

The following articles are practical examples of quality aspects implementation or assessment in different settings:


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