AE/PC/SRS reporting guidance
Full ABPI/BHBIA Guidance notes on collecting adverse events, product complaints and special reporting situations during market research explaining how to identify and record AEs/PCs/SRSs uncovered during MR project can be found on the BHBIA’s website. The guidance notes have been updated in February 2021 to include medical devices.
There is also a dedicated training module - see Online Training section for the training programme which includes a competency test.
The Guidance includes AE/PC/SRS reporting from social media and refers to specific ABPI Guidance notes on the management of safety information and product complaints from digital activities