ECSingleCenterStudiesEthicalReview object
Ethical approval (favourable opinion) to be obtained from
Local EC linked to the trial site
Additional Information
Single-centre studies are submitted to an EC set up by the health care provider on whose site the clinical investigation will be carried out.
The EC gives written consent to the conduct of clinical trials of a MD and oversees their progress in terms of safety and respect for the rights of subjects. For this purpose, it assesses the competence of examiners, including the principal investigator, the appropriateness of the equipment, procedures, and selected groups of subjects, independently of the authorities, investigators and administrative or other authorities.
