Training Program Title

Monitoring and Reporting Safety

Contributor

Duke University

CTSA Hub Administered

no

Training Program Description

This module defines adverse event and serious adverse events. It provides specific guidance for documenting an event correctly. This module provides regulatory guidance for determining if an event is reportable under 45 CFR Part 46. In addition, it discusses what, when, and how to report events to the FDA, sponsor, funding agency, ClinicalTrials.gov, and the DUHS IRB.

Competency Keywords

Best practice, Adverse event

Digital Commons Disciplines

Medical Education

Public

no

Cost to Access

no

Delivery Method

Online

Target Learners

Clinical Research Professionals (other than PI)

Learning Level

Skilled

Frequency

On demand

Associated Assessment

no

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