Principal Investigator (PI)

Catalog

The lead researcher responsible for the design, conduct, and oversight of a clinical or scientific study. They ensure the integrity of the research and compliance with regulatory and ethical standards. PIs often hold senior academic or clinical positions and have extensive experience in their field. They are accountable for the study’s progress, data accuracy, and reporting outcomes to sponsors and regulatory bodies.

Featured Courses

Auditing of a Clinical Research Site

This module provides a detailed understanding of the auditing process in clinical research and how it ensures compliance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. Learners are introduced to the distinctions between monitoring, auditing, and inspection, as well as the purpose, scope, and procedures that define an effective audit. The course outlines auditor qualifications, essential steps before, during, and after an audit, and the documentation required for evaluation, including regulatory binders and investigator credentials.

2026

View course

Introduction to Healthcare Delivery Science

The goal of this program is to enhance researchers' understanding of key principles in healthcare delivery science using an multidisciplinary approach.

Researchers who are interested in applying to the Health System Innovation and HDS Seed Grant funding opportunities are encouraged to view all introductory lectures before submitting a Letter of Intent.

View course

Monitoring of a Clinical Trial Site

This module introduces the fundamental principles and practices involved in monitoring clinical trial sites. It covers definitions and types of clinical trials, the application of Good Clinical Practices, and the roles and responsibilities of sponsors, investigators, and institutional review boards. Learners will review essential documentation processes and quality functions such as data capture, quality control, and assurance. The module also explains the purpose and scope of trial monitoring, including the qualifications and responsibilities of monitors, data standards like ALCOA + CCEA, and the different types of monitoring activities.

2026

View course

Regulatory Science Symposium: Product Development in a Digital World

View course

Seminar Series

The Seminar Series is an educational initiative that supports clinical and translational researchers through expert-led sessions focused on innovation, collaboration, and career development. Covering topics from scientific communication to regulatory science and team leadership, the series equips researchers with the tools and knowledge to accelerate the translation of discoveries into real-world health solutions.

Self Paced/Ongoing

View course

Site Preparedness for FDA Inspection

This module provides an overview of the FDA inspection process and the steps sites should take to ensure continuous readiness. Learners will explore the similarities and differences between audits and inspections, the key stages of an inspection, and the circumstances that may prompt an FDA site visit. The course emphasizes the importance of mock inspections as a tool to evaluate compliance and identify areas for improvement before an official inspection occurs.

2026

View course