概要

DIA is pleased to present a three-part online training series focusing on clinical monitor oversight. Hear from experienced faculty on the trends impacting monitors, requirements, approaches, selection, and how to manage a site monitor’s performance. This course also focuses on the elements of risk-based monitoring.
Course Level: Intermediate

何を学ぶか

Trends in the clinical development landscape driving change
ICH and FDA requirements for site monitoring
Current approaches to risk-based monitoring
Warning signs and problems with site monitors
Managing site monitors and their performance
Common errors made in site monitoring
Metrics used to measure site monitor performance

参加対象

Professionals who work with or manage site monitors
Sponsors from small-to-mid-size pharmaceutical, biotechnology, and device companies who have clinical operations responsibilities including interaction with sourcing site monitors

学習目的

At the conclusion of this activity, participants should be able to:

Describe the current factors impacting clinical development necessitating change
Recognize the impact on approaches to risk-based monitoring from FDA Guidance and TransCelerate viewpoints
Identify audit trends and inspection findings relative to site monitoring
Discuss how to develop measurable expectations and objectives for site monitors
Identify best practices in managing site monitors

Oversight of Clinical Monitoring: Trends and Strategies

概要

何を学ぶか

参加対象

学習目的

最新情報や機会を逃さないで