Guidelines & Legislation

A pro-innovation approach to AI regulation - GOV.UK White Paper

ABPI Disclosure Requirements

Disclosure requires pharmaceutical companies to make publicly available the details of MR-related payments, on a named basis, IF the identities of HCPs or HCOs who take part in the MR are intentionally known or disclosed to the pharmaceutical company. This summary outlines the basics of the requirements.

AE/PC/SRS Collection from Market Research - Quick Guide

This guide is suitable for anyone who needs an overview of the adverse event, product complaint and special reporting situation reporting requirements that apply to market research conducted in the UK.

AE/PC/SRS Data Collection Form

The AE/PC/SRS Data Collection Form as a word document, for your convenience when adapting for specific projects.

AE/PC/SRS Reconciliation Form

The AE/PC/SRS Reconciliation Form as a word document, for your convenience when adapting for specific projects.

AE/PCS/SRS Reporting - FAQs

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.

An Introduction to Data Protection Law

An overview of the main principles and requirements of the GDPR

BHBIA/ABPI guidance on reporting adverse events, product complaints and special reporting situations

The Guidance notes on collecting adverse events, product complaints and special reporting situations during market research are produced by the BHBIA in conjunction with the ABPI.

Consent Guidelines

Consent is the freely given specific and informed agreement by a person (i.e. the ‘data subject’ or ‘respondent’) to take part in the MR and for the processing of their personal data. This guide summarises what you need to know (and includes all the new requirements under GDPR).

Consents for Market Research - what is required and when

Details the different consents that might be required during the course of a primary market research project and at what stage these consents must be secured, before or during fieldwork.