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 2021 ABPI/BHBIA Guidance notes on collecting adverse events, product complaints and special reporting situations during market research.
Example wording to use with market research participants when:
- informing them that the MRA will give the MAH details of any AEs/PCs/SRSs
- asking if they are willing for the MRA to give their contact details to the MAH should an AE/PC/SRS come to light during the research
This wording is for information only and is neither mandatory nor constitutes legal or regulatory advice.
(Please note: These are not fully formed consent agreements, and you will need to add further specific detail e.g. the name of the recipient company. For more information about consent agreements please see the BHBIA’s Consents for Market Research – what is required and when? guide in the Privacy & Data Protection section of the website, or section E4.2 of the BHBIA’s Legal and Ethical Guidelines).
This document includes the following specific standard paragraphs:
- 6.1 Recruiting an HCP to participate in market research
- 6.2 Before an HCP participates in market research
- 6.3 When an HCP raises an AE/PC/SRS during market research
- 6.4 Recruiting a patient/caregiver to participate in market research
- 6.5 Before a patient/caregiver participates in market research
- 6.6 When a patient/caregiver raises an AE/PC/SRS during market research
- 6.7 The start of a market research internet study where HCP respondents can enter free text
You should work with the MAH to agree:
- the appropriate privacy notice that the MRA should give market research participants
- when to give the privacy notice
- appropriate record keeping of the privacy notice given to them