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 7, dated July 2018.
The 7th Revision of the Guide on Methodological Standards in Pharmacoepidemiology includes revisions, amendments and new references in all the chapters. Revisions were performed by the authors in collaboration with the editorial group. External comments received were also considered.
Due to developments in some areas or need for restructuring and clarification, the ENCePP Guide has been more significantly revised in the following chapters:
Chapter 5.9 is complemented by Annex 2 which provides more detailed guidance on methods for pharmacovigilance impact research developed by an ENCePP Special Interest Group.
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 may be forwarded to firstname.lastname@example.org.
|10. Specific topics|
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|
|Annex 2.||Guidance on methods for pharmacovigilance impact research|