Adverse Events
Identifying and monitoring adverse events (AEs) is critical to protecting research participants and ensuring quality data. This module will provide an overview of AEs, including assessment, documentation, recording, and reporting including non-AEs that are reportable to the IRB. The content of this module is from the “Introduction to the Principles and Practice of Clinical Research” course presented by Elizabeth Ness, MS, BSN, RN, CRN-BC™ in July 2023. Once you have completed all 4 required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
Module Objectives
At the conclusion of this module, learners will be able to:
Required | ||||
Part 1 | IPPCR: Adverse Events Reporting Part 1 of 4: AE Definitions (16 minutes) | |||
Part 2 | IPPCR: Adverse Events Reporting Part 2 of 4: AE Assessment and Documentation (33 minutes) | |||
Part 3 | IPPCR: Adverse Event Reporting Part 3 of 4: AE Reporting for IND and IDE Trials (28 minutes) | |||
Part 4 | IPPCR: Adverse Events Reporting Part 4 of 4: Event Reporting to the IRB (23 minutes) |