A Competency-Based Approach to Principal Investigator Responsibilities™

This course builds on foundational knowledge and provides practical, hands-on learning based on real-world scenarios, giving employers confidence that investigators are properly equipped to navigate problem resolution and risk mitigation.

This one-day course will look at the practical application of clinical research competencies as they relate to the role of the principal investigator and site staff. Through lecture, case examples and interactive exercises this course will focus on both the “WHY BEHIND” and the “HOW TO TRANSLATE” regulatory requirements into more efficient clinical trial conduct. By leveraging the competency requirements of clinical research coordinators and other research staff, participants will learn how to be more efficient in delegating responsibilities so that they are more effective as well as compliant in performing their duties as a Principal Investigator.

Learning Objectives

At the end of this session the participants should be able to:

• Describe the core elements of key regulatory guidance documents as they relate to the roles and responsibilities of the Principal Investigator
• List the expectations that regulatory agencies and sponsors have for Principal Investigator oversight of clinical trial conduct and examine whether given situations fulfill these expectations
• Explain the role, value and purpose of competency guidelines and how they can be used to facilitate the appropriate delegation of responsibilities to other staff
• Identify key risk areas with regard to investigator oversight and delegation of responsibility and develop strategies for minimizing risks and maximizing the quality of clinical trial conduct

Audience

Investigators

Accreditation Statements

• Jointly provided by Postgraduate Institute for Medicine and ACRP.
• This activity has been approved for AMA PRA Category 1 Credit(s)™.

This course is approved for 7.0 CME hours. No ACRP contact hours are offered.