Investigator

From IDWiki
  • In the context of clinical research in Canada, an investigator is a person responsible for the conduct of a clinical trial at a trial site
    • If research at the site includes a team, the investigator is the responsible leader and may also be referred to as the principal investigator or qualified investigator
  • A principal investigator is US terminology, not applicable in Canada
  • A qualified investigator is defined by Health Canada as the person responsible to the sponsor for the conduct of the clinical trial at the site, who is entitled to provide health care under the laws of the province where the site is located, and who is a physician and a member in good standing of a professional medical association
    • There is only one QI per study per Canadian study site, so it is effective the principal investigator for a given study site in Canada
  • A sub-investigator is a qualified member of the clinical trial team who is designated and supervised by the investigator at the trial site to perform trial-related procedures or make trial-related decisions
    • Typically a physician, associated, resident, or research fellow