Principal Investigators (PI)
The role of the nurse as a PI, you assume responsibility for the whole of your research study, including any responsibility delegated to study coordinators and research team members. The full scope of PI responsibilities is described in the Investigator’s Agreement which you electronically sign in iRIS when you submit a study. Use the link below to review the Duke IRB policies about serving as a PI.
All Principal Investigators must complete the following modules in addition to the Duke Health Biomedical Research with GCP (Good Clinical Practice) CITI training modules.
1. Additional CITI training for Duke Health and Staff Responsible Conduct of Research (an additional 6 modules). This is found at https://www.citiprogram.org, and you add this course to your CITI account (see the attached PDF, as it requires several steps to access it).
2. Complete the following modules in the Duke Health Learning Management System:
• Responsibilities of Principal Investigators Conducting Research at Duke Health – DOCR 00151084
• Study Documentation Regulations and Best Practices – DOCR 00137344
• Informed Consent Process and Procedures for Clinical Research – DOCR 00150119
• Fundamentals of Clinical Research Data Management & Collection – DOCR 00163171
3. OnCore Training: All studies, including QI exempt, are linked to OnCore. Nurse PIs can complete this optional PI training in OnCore (OnCore PI Essentials by DOCR), but not required as our Nursing Research Program will enter the minimum required footprint for QI exemptions. However, suppose subject accrual entry is required for a research study. In that case, the PI of the study MUST complete OnCore Training for the Clinical Research Coordinator in order to request the OnCore account. In addition, you must complete the OnCore Training for the Regulatory Coordinator who is needed to complete the minimum footprint to register subjects. Info on OnCore training is attached for you to keep for future reference.
Individuals Who May Serve as PIs for Duke HRPP
The status of principal investigators is granted as a matter of privilege to regular rank faculty and to select senior administrative staff. The Duke IRB does not permit students to be Principal Investigators on any project. The Nursing Research Program will identify the appropriate PI for your project.
