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Master Thesis

Erreur médicamenteuse dans les essais cliniques institutionnels : d’un retour d’expérience à une ligne directrice nationale

Abstract : The investigational drugs system is complex and has specific risks. Medication Errors (ME) associated with adverse reactions may occur. Because of two serious adverse events related to ME during a clinical trial sponsored by the Caen University Hospital, pharmacovigilant has been confronted with interpretation’s difficulties of the regulations. This work aims to change practices in the methods of collecting, coding and reporting EM in institutional clinical trials. A national survey was disseminated, to which 25% of REVISE’s group members (safety officers of French institutional sponsors) responded. It underlined practice’s heterogeneity. It was necessary to develop the culture of reporting these errors in clinical trials and a working group was established. Recommendations were issued by the REVISE group to clarify the investigator and sponsor responsibilities through guidelines, in particular that any serious or potentially serious ME or other “special situation” should be notified immediately to the sponsor by the investigator. Locally, some measures have also been taken by the Caen University Hospital’s sponsor and the pharmacist’s sponsor, in order to manage safety’s patients in the trials. The clinical research pharmacist role is essential to detect ME. The determination of pharmacist’s role into the reporting system, could be discussed with clinical research professionals and health authorities.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03448949
Contributor : Ufr Santé Unicaen Connect in order to contact the contributor
Submitted on : Thursday, November 25, 2021 - 2:25:42 PM
Last modification on : Wednesday, December 15, 2021 - 3:48:06 AM

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  • HAL Id : dumas-03448949, version 1

Citation

Chloé Fourage. Erreur médicamenteuse dans les essais cliniques institutionnels : d’un retour d’expérience à une ligne directrice nationale. Sciences pharmaceutiques. 2021. ⟨dumas-03448949⟩

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