2.1.1 The investigator(s) should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial and should provide evidence of such qualifications.
2.1.2 The investigator should be familiar with the appropriate use of the investigational product(s) as described in the protocol, in the current Investigator’s Brochure, in the product information and/or in other information sources provided by the sponsor.