Here’s what we’ve identified. You may have thought of other points too:

• Yes, this type of research can be done but it must be made clear that it is a hypothetical situation
• It is a launched product so all types of AE/PC/SRS may be raised – however off label use is the most likely and lack of efficacy may come up frequently (these are both Special Reporting Situations)
• There is the potential for a large volume of AEs/PCs/SRSs – what is the research methodology and would tabulated reporting be suitable?
• Has the PV department been consulted on volume and approach?
• Look for a statement of the need for reporting AEs/PCs/SRSs on both screener and guide – including anonymity statement and collection and recording of respondents’ willingness to proceed and under what terms