3.7.1 The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by education, training and experience and should demonstrate they have adequate resources and facilities to properly conduct the trial. If a coordinating committee and/or coordinating investigator(s) are to be utilised in multicentre trials, their organisation and/or selection are the sponsor’s responsibility, and their roles and responsibilities should be documented prior to their involvement in the trial.
3.7.2 The sponsor should provide the potential investigator(s)/institution(s) with the protocol and an up-to-date Investigator’s Brochure as well as sufficient time for the review of the protocol and the information provided.