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.
- 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.
Senior Director, Compliance Programs
Director, Data & Privacy Protection
Who should watch?
This content applies to research coordinator and regulatory staff from hospitals, universities, academic medical centers, and independent research sites as well as study sponsors and monitors.
This session meets the Certified IRB Professional (CIP) recertification guidelines for a maximum of 0.5 credit.
Provider approved by the California Board of Registered Nursing, Provider Number 16549, for 1 contact hour. This documentation must be retained by the licensee for a period of 4 years after the course concludes.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.
If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.
Certificate of Attendance
After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.
DATE: April 1, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour