RESUMEN
OBJECTIVES: Carry out a national inventory of the current situation regarding the quality management of the investigational health products circuit, to develop adapted standardised tools. METHODS: A survey of 76 questions, developed by a regional working group, was conducted among clinical research pharmacists in French facilities. Tools were developed to meet the identified needs and validated by participating pharmacists, using the Delphi method. The consensus was defined by achieving a score above 80% on relevance, clarity and evaluability. RESULTS: Among 94 pharmacists participating in the survey, 88 were interested in standardised tools. The score for the implementation of a quality approach depended on the type of health facility (P<0.0005) and increased with the number of active trials (P<0.0005). All nine proposed tools were useful for over two thirds of pharmacists, but the self-assessment and audit grids have been prioritised. Indeed, only 26% of pharmacies carried out a prior risk assessment and 14% carried out internal audits. The review of both grids led to a consensus on 89% and 97% of the criteria respectively. The validated grids include 62 and 72 criteria respectively. DISCUSSION: The quality approach of the investigational health products circuit is heterogeneous in the participating centres, with a strong need for standardised tools. The two grids are relevant tools developed by and for professionals. CONCLUSION: The tools developed will enable to optimise the quality approach by identifying the non-conformities of the investigational health products circuit.