Resources
ABPI/BHBIA suggested wording/standard paragraphs:
Click on the links below for word documents containing suggested wording/standard paragraphs which members can adapt to their own needs for inclusion in questionnaires, guides etc.
These documents are based on the Annexes to the 2013 ABPI/BHBIA Guidance notes on the collection of adverse events and product complaints from market research programmes.
Annex 4 - Prior to MR activity - HCP
Annex 5 - During MR study - HCP
Annex 8 - If an AE is raised - HCP
Annex 9 - Prior to MR activity - patient/non-HCP
Annex 10 - During MR study - patient/non-HCP
Annex 11 - If an AE is raised - patient/non-HCP
Annex 12 - Introduction to an internet MR study - HCP
ABPI Publications (2013):
BHBIA Publications (2011):
- AE Reporting Frequently Asked Questions
Responses to some of the most common queries from BHBIA members over the 12 months following the significant changes to AE reporting guidance that came into effect in 2010, produced in conjunction with the ABPI PEN.
