Background and importance Despite a strict regulatory framework of clinical trials (CTs), few standardised tools are available. Our national survey conducted in 2020 demonstrated that all clinical research pharmacists (CRPs) have initiated a quality approach, which is however very heterogeneous and implemented more in university hospital centres and cancer centres, with a high activity level. New standardised tools for the investigational health products (IHPs) circuit would be of interest to 88/94 CRPs. The most useful tool was the self-assessment grid, according to 94% of CRPs. Thus we developed such a tool to manage specific risks of IHPs (complex protocols, assignment of treatment numbers, confusing packaging or labelling).
Aim and objectives The aim of this work was create a standardised self-assessment grid to manage the specific risks of IHPs.
Material and methods A pharmacy resident and two doctors of pharmacy of a regional working group defined a list of 66 evaluation criteria, mainly based on good clinical practices and on a professional guide of 2020 by the national university centre hospitals’ pharmacists commission. The criteria were divided into three main parts: general organisation and support functions; pharmaceutical management of CTs; and risk assessment and risk management. Then the grid was sent for validation to the 94 CRPs who had answered our national survey. The Delphi method was used and consensus among experts was defined by a satisfaction rate of >80% for relevance, clearness and accessibility.
Results The first round of proofreading by 16 pharmacists led to a consensus of 85% (56/66) for the criteria, which were considered relevant, clear and assessable. This led to 36 modifications, 4 deletions and 2 additions of criteria. The second round by 8 pharmacists led to a consensus of 88% (60/68) for the criteria and resulted in 18 modifications and 2 deletions. There remained only one criterion considered irrelevant, which was deleted. These results led us to validate the final version of the grid, including 62 criteria.
Conclusion and relevance This interactive tool will be disseminated in a free public online ‘CTs’ toolbox. It will provide a conformity score per process, allowing specific risks to be identified across the circuit of IHPs, by pharmacies in any healthcare facility, whatever the level of activity.
Conflict of interest No conflict of interest
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