Overall objective: To ensure the market research meets company and regulatory standards with regard to the appropriateness of approach and the materials used.

MR material should be examined by the commissioning client company to ensure that it does not contravene the ABPI Code of Practice 2021. (certification is not required). The appointed person should be sufficiently familiar with the ABPI Code, and all MR materials i.e. screeners, guides/questionnaires and stimulus should be examined.

The purpose of examining/reviewing market research materials is to help ensure that:

• The ABPI Code is adhered to (e.g. avoiding disguised promotion – more detail on this to follow) and regulators’ requirements are met
• Your company’s MR projects meet internal standards
• Data protection legislation has been complied with
• Pharmacovigilance (PV) / Drug Safety requirements related to the MR process are met (This might include understanding the potential for any AEs/PCs/SRSs, ensuring appropriate PV information is provided to participants, and that the means to collect/reconcile PV information is in place)
• Incentives are in line with company fair market value rates

Reviewers from any or all of the following departments may be involved in examining and evaluating the materials to ensure that they comply with the policies required by the reviewer’s area of expertise:

• Medical/Medical Affairs
• Compliance/Legal
• Pharmacovigilance (PV)/Drug Safety
• Other commercial departments such as Product Strategy, Market Access and Communications
  

Refer to the following sections of the Guidelines for further information:

• Section H3: Research Ethics Committee Approval
• Section H4: Disguised promotion
• Section H6: Adverse Events/Product Complaints/Special Reporting Situations

See also the full BHBIA/ABPI guidance on reporting adverse events, product complaints and special reporting situations