Remote Monitoring: Study Compliance in a Changing World

Effective remote monitoring plans enable sites and sponsors to maintain trial participant safety, data quality, and data integrity. With limited availability to access research sites in person over the past year, sponsors and monitors rapidly changed how they review study procedures, subject status, and study progress at research sites. Challenges included: HIPAA-compliant tools to provide remote access to source materials, restricting medical record access to only the information needed, limiting the amount of time information is available, and promptly removing access when remote monitoring is complete. Risks to cancelled and delayed monitoring visits include late identification of serious or continuing non-compliance, including serious adverse events.

It has never been more important for sponsors, monitors, and sites to learn how best to conduct monitoring visits remotely and securely. In this webinar, Emily Eldh and Ben Shankle of Advarra will provide considerations for implementing remote monitoring in a changed research landscape.

Learning Objectives:

• Analyze the risks of missed monitoring visits with the challenges of implementing remote monitoring methods.
• Understand the FDA’s guidance on delayed or missed monitoring visits due to the COVID-19 pandemic including documentation requirements for changes in monitoring methods and timing.
• Consider FDA Inspectional Readiness in a remote environment.
• Review methods for conducting remote monitoring visits, avoid technological challenges, and minimize data privacy and security concerns.
  

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