Principal Investigator (PI)
The Principal Investigator is the person who has primary responsibility for the design, execution, and management of a research project and is involved in the project in a significant manner. The PI is also responsible for the protection of the rights and welfare of the human subjects and adherence by all study personnel to UMKC requirements, as well as applicable university policies, state statutes, and federal regulations.
This can be a Sub-Investigator, Co-Investigator, Student Researcher, Resident or Fellow. Student, Resident, and Fellows acting as Investigators are not considered by UMKC to be the PI on any research project.
The individual who most often has the responsibility of monitoring the day to day operations of the research study. Although the PI is responsible for the conduct of the research, it is often the Coordinator who carries forward the research goals, thereby playing a significant role in the success of the research study. Most importantly, Coordinators are often involved in conducting the informed consent process and ensuring compliance with the protocol. Although not inclusive, some of the Coordinators responsibilities include preparing the Institutional Review Board submission, helping to design the informed consent document, working with the institutional official in contract negotiations, subject recruitment, patient care, adverse event reporting, preparing the case report form (CRF), submitting CRFs and other data to the IRB as necessary and study close-out.
The Administrative Contact is an individual who has administrative responsibilities on the project and/or is the administrative assistant for the PI. The Administrative Contact could also be one of the study personnel.
Other (Study) Personnel includes any individual who contributes in a substantive way to the design, conduct, and/or analysis of the data of a study at or on behalf of UMKC that does not meet one of the criteria identified above. In addition, this Personnel section is designed to capture individuals not currently found in the UMKC eProtocol system.