The Guide on Methodological Standards in Pharmacoepidemiology offers a single web resource for methodological English language guidance in pharmacoepidemiology. For each topic covered, direct electronic access is given to internationally agreed recommendations, and key points from important guidelines, published articles and textbooks are highlighted. Where relevant, gaps in existing guidance are addressed with what ENCePP considers good practice.
The current version of the Guide is Revision 9, dated July 2021.
The 9th Revision of the Guide includes extensive amendments, new references in most of the chapters, and an improved structure.
The Foreword highlights the importance of the Guide in the context of the COVID-19 pandemic and vaccination campaigns. Nearly all chapters contain relevant guidance on methodological standards to be used in COVID-19 studies, with references to selected publications illustrating relevant methodological aspects.
The Guide is updated annually by structured review to maintain its dynamic nature. It may also be amended as necessary in response to comments received. For this purpose, any comment and additional relevant guidance document(s) may be forwarded to ENCePP_Secretariat@ema.europa.eu.
|Foreword to ENCePP Guide Revision 9|
|10. The statistical analysis plan|
|11. Quality management|
|12. Dissemination and communication of study results|
|13. Data protection and ethical aspects|
|14. Specific topics|
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|