Where an adverse event (AE), product complaint (PC) or special reporting situation (SRS) is raised during market research it is subject to the normal reporting rules

For full details see the joint ABPI/BHBIA Guidance notes on collecting adverse events, product complaints and special reporting situations during market research.

Reporting AEs/PCs/SRSs uncovered during fieldwork 

The market research agency should be supplied with a list of medicines for which the commissioning company holds the marketing authorisation (or for medical device research, a list of devices for which they hold the certificate of conformity).

ALL respondents citing an AE/PC/SRS must be asked for their contact details so that they can be approached for further information (if this is required) at a later date by the commissioning company’s PV department

• Respondents must be made aware of the requirement at recruitment and again at the start of the interview
• Contact details can only be passed on if the respondent gives their consent or another lawful basis is in place
• If a respondent declines to pass on their/ personal contact details, the interview can still take place and the event reported anonymously

In some situations, it is acceptable to provide tabulated AE/PC/SRS reports

• Where this is the case the arrangement will be made between the pharmacovigilance (PV) department, the research agency and the company person running the study

An AE/PC/SRS reconciliation form must be completed at the end of every study – including those where no AEs, PCs or SRSs are reported