Investigator responsibilities

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  • By signing the FDA Form 1572, the Principal Investigator (PI) agrees with the FDA to have total oversight of the protocol at his/her site. The PI can delegate the procedures but agrees to follow the protocol and protect patients rights with Good Clinical Practice
  • To be available to meet with monitors, sponsors, and FDA auditors
  • Attend investigator meetings
  • In addition to completing the subject visit, he/she will need to review:
    • Obtained informed consent process
    • Inclusion and Exclusion Criteria
    • Assessments per protocol: Labs, Physicals, AEs, and EKGs
    • IND Safety Reports and Confirm they are submitted to IRB