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I. INTRODUCTION

I. INTRODUCTION — Scope and Purpose for Clinicians, R&D Scientists, Formulation Scientists, Regulatory Affairs Personnel, QA/QC, and Validation

II. BACKGROUND

II. BACKGROUND — Regulatory Framework for Safety Reporting in IND and IDE Studies

III. DEFINITIONS

III. DEFINITIONS — Key Terms for Drugs and Devices Safety Reporting

A. Drugs — Definitions Relevant to IND Safety Reporting

B. Devices — Definitions Relevant to IDE Safety Reporting

IV. INVESTIGATOR RESPONSIBILITY FOR REVIEWING SAFETY REPORTS

IV. INVESTIGATOR RESPONSIBILITY FOR REVIEWING SAFETY REPORTS — Assessment, Documentation, and Communication

V. INVESTIGATOR REPORTING TO SPONSORS FOR IND STUDIES

A. Serious Adverse Event Reporting — Criteria and Required Content for IND Studies

B. Timing of Serious Adverse Event Reporting — Immediate and Follow-up Requirements

C. Study Endpoint Reporting — Differentiation from Adverse Events

D. Nonserious Adverse Event Reporting — Collection, Evaluation, and Submission

Quiz: IND Investigator Reporting to Sponsors — SAE, Timing, Endpoints, and Nonserious Events

VI. INVESTIGATOR REPORTING TO INSTITUTIONAL REVIEW BOARDS FOR IND STUDIES

VI. INVESTIGATOR REPORTING TO INSTITUTIONAL REVIEW BOARDS FOR IND STUDIES — Required Submissions and Timelines

Quiz: IRB Reporting for IND Studies — Unanticipated Problems and Continuing Review

VII. INVESTIGATOR REPORTING TO SPONSORS AND INSTITUTIONAL REVIEW BOARDS FOR IDE STUDIES

VII. INVESTIGATOR REPORTING TO SPONSORS AND INSTITUTIONAL REVIEW BOARDS FOR IDE STUDIES — Unanticipated Adverse Device Effects and Other Requirements

Quiz: IDE Investigator Reporting — UADEs, Device Incidents, and Timelines

VIII. SPONSOR RESPONSIBILITIES

VIII. SPONSOR RESPONSIBILITIES — Interface with Investigator Safety Reporting

Quiz: Sponsor and Investigator Interfaces — Signal Detection and Required Communications

Investigator Responsibilities

Capstone Quiz: Investigator Responsibilities — Integrated Safety Reporting for IND and IDE Studies

Course Feedback Survey — Safety Reporting for Investigational Drugs and Devices

Strengthen your clinical research compliance with Investigator Safety Reporting for IND Drugs and Devices—a practical, regulation-aligned course designed for investigators and study teams working under FDA IND and IDE requirements. This course demystifies the who, what, and when of safety reporting so you can confidently assess events, document findings, and communicate with sponsors and IRBs within mandated timelines. You’ll learn how drug and device regulations differ, how to distinguish study endpoints from adverse events, and how to manage serious versus nonserious cases with precision. Through focused modules, real-world scenarios, and targeted quizzes, you’ll build a repeatable workflow for event triage, causality and expectedness assessments, expedited reporting, and follow-up documentation. The curriculum spans foundational definitions through advanced reporting interfaces with sponsors, IRBs, and device-specific UADE requirements—equipping clinicians, R&D and formulation scientists, regulatory affairs, QA/QC, and validation professionals with shared language and standard practices. By the end, you’ll know exactly what to report, to whom, and by when—reducing site burden, avoiding over-reporting, and improving participant safety oversight. If you’re ready to translate FDA expectations into day-to-day actions and pass audits with confidence, this course is for you.

Investigator Safety Reporting for IND Drugs and Devices

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            <p>Investigator Safety Reporting for IND Drugs and Devices equips practicing clinicians, R&D and formulation scientists, regulatory affairs professionals, and QA/QC and validation specialists with a rigorous, end-to-end understanding of safety obligations in clinical investigations. Grounded in the FDA’s IND and IDE frameworks, the course clarifies scope and purpose across functional roles, ensuring that participants can distinguish regulatory expectations, harmonize internal procedures, and uphold subject protection and data integrity. Through a progressive structure—beginning with foundational background and definitions for drugs and devices—learners develop fluency with critical terminology that underpins accurate assessment, documentation, and communication of safety information.</p>

<p>Building on that foundation, the course details investigator responsibilities for reviewing safety reports, reporting to sponsors in IND studies (including criteria, content, timing, and differentiation from endpoints), and reporting to Institutional Review Boards. It further addresses IDE-specific requirements, emphasizing the correct handling of unanticipated adverse device effects and related timelines. The program also maps sponsor responsibilities and the investigator–sponsor interface for signal detection and required communications, reinforcing operational alignment across teams. Knowledge checks and capstone assessments consolidate learning to ensure participants can implement compliant, timely, and high-quality safety reporting practices tailored to the demands of their roles in clinical development.</p>
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