COURSE DESCRIPTION

OVERVIEW

The recent COVID-19 outbreak has disrupted clinical trials drastically. Monitors are grounded but data still needs to be monitored. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released new guidance with updates for industry about COVID-19 and patient safety. The question remains – how do we do this without putting our monitors or trial subjects at risk while staying compliant?

This course discusses the real feasibility of remote monitoring of the quality of original source data in compliance with clinical trial predicate rules, including HIPAA and FDA. This is not asking trial sites to be burdened with scanning and redacting documents or, to risk security breaches. The review of source data in a risk-based regulatory environment is centered on the quality of the documentation – not the comparison of the source to the electronic case report form (eCRF). As such, this crisis is an opportunity to propel us further into enhancing a risk-based culture while having the agility to keep trials moving during crises…like the current pandemic.

During this webinar, our expert instructor will present:

• Application of the FDA and EMA guidance to real case scenarios
• A simple process for working together as sponsor and site to ensure quality data during forced remote work
• How to overcome the many barriers of quality data review when remote monitoring
• The elements in a quality management system (QMS) that need to be in place or updated at trial sites (and within sponsor firms) to initiate successful remote monitoring now and in the future
• Strategies to ensure audit readiness for all

LEARNING OBJECTIVES

Attend this interactive live session and you will be able to:

• Clarify what data are accessible remotely from HIPAA covered entities
• Develop agreements between stakeholders to support remote source review
• Identify how to evaluate the feasibility of remote monitoring of the quality of site source data without threat of security breach
• Promote better remote monitoring practices and documentation