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 sponsor’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

The primary route for reporting AEs/PCs/SRSs is using the AE/PC/SRS Data Collection Form

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

• Requirements apply to all research types and methodologies including social media, except where data is taken from longitudinal patient databases