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Principal Investigator

  • Assures all investigators and key study personnel complete initial and continuing education in human research protections annually, to remain up-to-date on federal regulations, Vanderbilt policies and procedures, and compliance expectations. This entails completing the three to four required CITI modules initially, then one additional module or human research protection educational session annually providing documentation of completion to the IRB.
  • Adheres to federal regulations, state and local laws, institutional policies, IRB policies and procedures regarding the safety and protection of human participants, and Good Clinical Practice (GCP) guidelines.
  • Reports adverse events and unexpected problems involving risk to participants and others to the IRB according to Institutional policy, IRB policies and procedures, DSMB/C, VU or VUMC Risk Management, sponsors, and appropriate federal agencies as required.
  • Assures continuing review applications are submitted in a timely manner so that review occurs prior to the expiration date. The Investigator acknowledges that the federal regulations do not allow a grace period. The Investigator is responsible for being aware of the current literature in his/her field of study to assure participants are no longer placed at risk if additional risks have been identified or no benefit has been proven. The Investigator should build off previously conducted research to decrease the potential for participants to be needlessly placed at risk.
  • Acts as a liaison between the IRB and the sponsor.
  • Supervises the research process. Takes responsibility for assuring key study personnel are properly trained, qualified, and have appropriate facilities and resources to conduct the research. Assures adherence to the study protocol. Monitors the informed consent process. Communicates regularly and effectively with the research staff. Responsible for protection of the safety and welfare of research participants.
  • Oversees external performance sites, assuring adequate staff, resources, pharmacy practices, and Federal assurances with appropriate IRB approvals.
  • Assures the IRB protocol is reflected in the grant proposal for extramural or intramural support, informs the IRB of any updates or modifications to the protocol prior to their implementation and in compliance with federal and institutional regulations.
  • Assures proper performance of the informed consent process. Retains a copy of the signed and dated informed consent document in the study file and provides a copy to the research participant.
  • Promotes compliance and maintains documents in accordance with federal and state regulations, sponsor, and institutional policies and procedures regarding the safety and welfare of human participants.
  • Reviews and approves IRB applications, amendments, and adverse events prior to submission to the IRB, as documented by a signature on the IRB application.
  • Assures participant privacy and confidentiality according to HIPAA guidelines, institutional regulations, and IRB policies and procedures.