Impartiality of inspectors
Article 23
The competent authority shall ensure that inspectors are free of any undue influence that could affect their impartiality and judgment. Inspectors shall be independent, in particular, of: (a) the sponsor; (b) the management and personnel of the clinical trial site; (c) the investigators involved in the clinical trials where the investigational medicinal products manufactured by the inspected manufacturer are used; (d) the persons financing the clinical trial in which the investigational medicinal product is used; (e) the manufacturer. Inspectors shall make an annual declaration of their financial interests in the parties inspected or other links to them. The competent authority shall take the declaration into consideration when assigning inspectors to specific inspections.