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ENCePP Guide on Methodological Standards in Pharmacoepidemiology


11.4. 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, 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).


Real-World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe (Clin Pharmacol Ther. 2019; 106(1):36-9) describes four criteria for acceptability of RWE for regulatory purposes: Derived from data source of demonstrated good quality, Valid (internal and external), Consistent and Adequate. Challenges for this acceptability and possible solutions in the EU context are presented.

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


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