Adverse Event Reporting Resources

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 2018 ABPI/BHBIA Guidance notes on collecting adverse events, product complaints and special reporting situations during market research.

Annex 2

Example of market research contract clause wording relating to AE/PC/SRS reporting requirements

Annex 6

Examples of wording for use in market research interviews in relation to AE/PC/SRS reporting

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 eg. the name of the recipient company. For more information about consent agreements please see the BHBIA’s GDPR Update on Consent for market research or section E4.2 of the BHBIA’s Legal and Ethical Guidelines).

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