Principal Investigator (PI) Primer 06/12/25

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Add to Calendar Principal Investigator (PI) Primer 06/12/25 6/12/2025 1:00:00 PM 6/12/2025 2:45:00 PM America/Chicago For More Details: https://umncpd.cloud-cme.com/course/courseoverview?EID=6231 Description: It is essential that Principal Investigators (PIs) understand their role and responsibilities in conducting human research to ensure the rights, safety, and welfare of their research participants. The PI is ultimately responsible for the outcomes of a research study. There are Ethical Codes, Federal Regulations, and Institutional Policies specific to research that PIs must to know and follow. As the le... Live Webinar false MM/DD/YYYY


Date & Location
Thursday, June 12, 2025, 1:00 PM - 2:45 PM CST, Live Webinar

Overview

It is essential that Principal Investigators (PIs) understand their role and responsibilities in conducting human research to ensure the rights, safety, and welfare of their research participants.  The PI is ultimately responsible for the outcomes of a research study. There are Ethical Codes, Federal Regulations, and Institutional Policies specific to research that PIs must to know and follow. As the leader of the study, PIs are responsible for communicating these requirements to study team members. All human research studies at the University of Minnesota are subject to audits/inspections; therefore, it is important to be compliant.  Lastly, individual and institutional conflicts of interest will arise for some PIs. Identifying these conflicts can be challenging; but conflicts can be managed, if caught early. Recognizing when conflicts of interest occur is critical to the integrity and overall success of a research study. 


Objectives
At the conclusion of this course, learners should be able to:

  1. Describe the roles and responsibilities of a PI, according to the International Harmonization for Good Clinical Practice (ICH-GCP), Federal Regulations (FDA, DHHS, ect.), and University of Minnesota Policies.
  2. Identify the root causes for receiving an FDA 483.
  3. Discuss how to address and prevent common inspection findings.
  4. Define individual and institutional conflict of interest (COI).
  5. Identify the first step to manage COIs per institutional policy.

Registration
Registration for this course is limited to individuals affiliated with the University of Minnesota. For registration information, please contact Jess Wright,  at [email protected], Clinical and Translational Science Institute (CTSI); Translational Workforce Development Program.

Accreditation
In support of improving patient care, University of Minnesota, Interprofessional Continuing Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

Credit Designation Statements

American Medical Association (AMA)

 The University of Minnesota, Interprofessional Continuing Education designates this live activity for a maximum of 1.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Other Healthcare Professionals
Other healthcare professionals who participate in this CE activity may submit their statement of participation to their appropriate accrediting organizations or state boards for consideration of credit. The participant is responsible for determining whether this activity meets the requirements for acceptable continuing education.