Key Research Stages - Before Fieldwork
E. Approval and Registration of Proposals Prior to Fieldwork4.1
Researchers MUST inform clients if any of the work to be carried out for them is to be combined or syndicated with work for other clients (any other clients do not need to be named and MUST not be named without their permission).
In Spain, Farmaindustria member companies MUST provide prior notification to the Farmaindustria Code of Practice’s Surveillance Unit (CPSU) when carrying out, financing or sponsoring market research studies. This is NOT mandatory if:
–The pharmaceutical company funds less than 50% of the study OR
–The company does not have access before, during or after study, to the identity of the participating healthcare professionals and has not intervened in their selection beyond defining participating group described in the study protocol OR
–The study does not provide direct or indirect remuneration to the participating healthcare professionals OR
–The study involves paid participation of less than 20 healthcare professionals. It is not allowed to split a study into smaller units that share approach, objectives and methods.
Communication should be addressed to the Farmaindustria Code of Practice Surveillance Unit (CPSU) and sent at least ten working days before the study is due to start. The pharmaceutical company is responsible for reporting the study.
Prior approval from the CPSU is required if the market research could involve any of the following:
-A disproportionate or unusual sample structure in quantitative market research
-Linking the market research to a specific product/medicine
-Using results within any publication or promotional material.
However the CPSU recommends that all market research studies carried out in Spain should be reported on a voluntary basis (not just those that it is compulsory to report). For full details please see: http://www.farmaindustria.es/Farma_Public_ING/Codigo/codeofsanitaryprofessionals/index.htm
In Spain market research studies MUST be approved before being carried out by the pharmaceutical company scientific service or by the compliance officer in Spain, this is required by the Spanish Code of Good Practices for the Promotion of Medicines and Interaction with Healthcare Professionals.
In Korea KRPIA member companies must reports details of surveys quarterly on the form provided by the KRPIA and market research agencies MUST not disclose the identity of participating HCPs to the client company and selection of HCPs MUST be conducted independently by the agency.