Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not have conflicts of interest, are independent of the sponsor, the investigators involved and of natural or legal persons financing the performance study, as well as free of any other undue influence.
Il s'agit notamment, dans le cas d'études des performances, de l'évaluation des performances analytiques et, dans le cas d'études interventionnelles des performances cliniques, de l'évaluation des performances analytiques, des performances cliniques et de la validité scientifique, compte tenu de l'état de l'art;