This site uses cookies which will be set when you visit another page, unless you then choose to opt out. Find out more about our cookies.

BHBIA

Adverse Event Guidelines

Guidance notes on collecting adverse events, product complaints and special reporting situations during market research – produced by the BHBIA in conjunction with the ABPI PEN (Pharmacovigilance Expert Network).

The Guidance Notes explain:

  • What you need to do to meet your obligations to drug safety;
  • Specific requirements in introduced in 2018 that apply when collecting Adverse Events (AEs), Product Complaints (PCs) and Special Reporting Situations (SRSs) directly from patients/consumers;
  • How to manage data protection requirements when forwarding AEs, PCS and SRSs.

Download the August 2018 Guidance notes on collecting adverse events, product complaints and special reporting situations during market research now - This document replaces all previous versions.

  • AE guidlines

The following associated resources are available as word documents, for your convenience when adapting for specific projects:

AE/PC/SRS Data Collection Form

AE/PC/SRS Reconciliation Form

Frequently Asked Questions: our AE/PC/SRS reporting FAQ resource is a selection of real-life queries from members and the responses from our Ethics Advisor. It supplements the Guidance Notes, but does not cover all topics – please always check the main Guidance Notes document first – view the FAQ.

Cookies required

To use this functionality please enable cookies. Find out more about our cookie policy.

  Cookies are currently off.