The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies). The investigator should be thoroughly 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 in other information sources provided by the sponsor. A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.
This topic describes: Adequate Resources, Medical Care of Trial Subjects, Communication with IRB/IEC, Compliance with Protocol, Investigational Product(s), Randomization Procedures and Un-blinding, Informed Consent of Trial Subjects, Records and Reports, Safety Reporting, Premature Termination or Suspension of a Trial and Final Report(s).