The Association of Clinical Research Professionals

ACRP Competency-Based Approach to PI Responsibilities™ Training Program

ACRP’s competency-based approach to PI training 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.

ACRP’s Competency-Based Approach to PI Responsibilities™ program guides learners through interactive discussions of some of the most common challenges faced by investigators, providing a roadmap for a long and productive PI career.

Learning Objectives

Upon completion of this course, 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 to investigator oversight and delegation of responsibility and develop strategies for minimizing risks and maximizing the quality of clinical trial conduct and product

Specs & Features

  • Facilitated by Dedicated ACRP Instructors Who Are Subject Matter Experts
  • Delivered Through Combination of Independent Learning and Facilitated Instructor-Led Training
  • Designed to Meet Various Learner Styles Through Use of Text, Audio, and Learning by Doing
  • Community-Based Learning in Cohorts to Foster a Positive, Active-Learning Environment
  • Flexible Delivery Options Including In-Person, Virtual, or Teach-to-Train
  • Flexible Timelines to Help You Balance Training Commitment with Day-to-Day Priorities*
  • Concludes with Assessment to Validate Knowledge Gain and Justify ROI
  • Learners Earn ACRP Contact Hours to Support ACRP Certification Maintenance (if applicable)**

* This program is typically 40 hours and delivered over multiple days.
**The number of Contact Hours will be determined by the final course length.

Agenda

  • Welcome and Introductions
  • Principal Investigator (PI) Responsibilities: The What and Why
  • PI Oversight Responsibilities: Practical Application
  • Documenting Proper PI Oversight: The How
  • Delegation: Authority, Responsibility, and Logs
  • Clinical Research Competencies: The Basics
  • Puling It All Together: Recap of Regulatory Risk and Mitigations Through Proper Delegation
  • Wrap Up, Q&A, Evaluations