Clinical Research Education Series (CRES) | “PI Oversight in Clinical Research: From Regulation to Practice"

October 21, 2026

This session will explore the Principal Investigator’s responsibilities for effective oversight of clinical research, from understanding regulatory expectations to applying them in day-to-day study conduct. Participants will learn how to distinguish regulatory requirements from institutional, IRB, and protocol-specific expectations; appropriately delegate and supervise study activities; maintain oversight of critical areas such as informed consent, adverse events, and data review; and implement practical strategies for documenting PI involvement and oversight throughout the study.

 

Target Audience

Employees at Houston Methodist Hospital Research Institute 

Learning Objectives

Participant Learning Outcomes:

  • Identify key regulatory and GCP requirements related to PI oversight and involvement in clinical trial conduct.
  • Differentiate regulatory requirements from institutional policies, IRB requirements, protocol-specific requirements, and best practices. 
  • Describe the PI’s responsibilities when delegating trial-related activities, including appropriate qualification, training, and supervision of study personnel. 
  • Discuss PI oversight responsibilities related to informed consent, adverse events, laboratory and clinical data review, and other critical study activities. 
  • Evaluate strategies for documenting effective PI oversight, including delegation records, review/sign-off processes, and communication with the study team.

Course summary

Available credit: 
  • 1.00 Attendance
Course opens: 
09/08/2026
Course expires: 
10/26/2026
Event starts: 
10/21/2026 - 12:00pm CDT
Event ends: 
10/21/2026 - 1:00pm CDT
Add to calendar: 
Virtual Meeting
Houston, TX
United States

Virtual - ZOOM link with be provided to the registered participants.

Presenter(s) Info:

Brandi Showalter, PhD, RN, CNE
Assistant Professor of Nursing, Instructional

UTHealth Houston | Cizik School of Nursing

Department of Undergraduate Studies | 

 

1.00 Attendance

Available Credit

  • 1.00 Attendance
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