PI Safety Responsibilities—Clearly Explained
Understand what U.S. regulations and global standards expect from Principal Investigators when adverse events occur—and how those responsibilities extend beyond signing off on forms.
Practical Tools to Support PI Oversight
Walk through key tools and documentation resources that help PIs evaluate seriousness, relatedness, and expectedness, ensure participant care, review safety reports, and maintain oversight across the safety lifecycle.
Built for Real-World Site Practice
Designed for coordinators, investigators, and site staff who need practical clarity—not theory—before moving into reporting pathways, timelines, and regulatory submissions.
PI Oversight in Practice
Adverse event management is one of the most critical responsibilities of a Principal Investigator—and one of the easiest places for uncertainty to creep in. In this session, we focus on PI responsibilities for adverse events under U.S. clinical trial regulations, walking through what PIs are expected to recognize, evaluate, document, and oversee when safety events occur. You’ll learn how seriousness, relatedness, and expectedness are assessed in practice—and how those assessments drive participant care, reporting obligations, and regulatory oversight. Beyond definitions, this session emphasizes practical tools and documentation resources that support PI oversight across the safety lifecycle. We walk through how PIs use structured approaches, safety reports, and documentation practices to maintain visibility into participant safety, respond appropriately to events, and demonstrate ongoing oversight to sponsors, IRBs, and regulators. Designed for real-world site practice, this session translates regulatory expectations into clear, usable workflows—helping PIs and site teams move from uncertainty to confident, defensible decision-making. If you support or serve as a PI in a U.S.-regulated clinical trial and want clarity on what oversight really looks like in practice, this session provides the foundation.
Want to keep building your safety reporting foundation?
This session is part of the Safety Reporting for Sites: A Foundations Series bundle, which brings four safety reporting sessions together into one cohesive learning path—available in the ClinIQ Academy catalog.
Curriculum
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1
Safety Reporting- Site Responsibilities and Documentation- Drugs and Devices
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(Included in full purchase)
Safety Reporting- Site Responsibilities and Documentation- Drugs and Devices
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(Included in full purchase)
Start learning on your path to clinical research confidence.
Safety reporting starts with strong PI oversight. Build clarity around investigator responsibilities, protect participants with confidence, and support compliant, inspection-ready site practice from the very first adverse event.
$10.00