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ENCePP Guide on Methodological Standards in Pharmacoepidemiology


12.4. 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 520/2012, GVP Module I, FDA’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 GPP 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 textbooks of epidemiology cited in the Introduction chapter of this Guide.

Chapter 15.7 (Real-world evidence and pharmacoepidemiology) discusses recommendations issued by regulatory authorities as regards the quality of studies based on observational data conducted for regulatory purposes in terms of, e.g., reliability of data sources, relevance, study designs and transparency.

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



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