On-Demand Webinar

Thorny Issues in Medical Device Research

Governed by a complex thicket of regulatory requirements, the landscape surrounding device research can sometimes seem a dense and prickly space.

Watch this webinar to learn how to navigate thorny issues in medical device research, including which regulatory requirements apply to different types of device studies and the unique challenges of studies involving mobile apps and wearable devices.

IRB chairpersons Kindra Cooper and Robert Romanchuk will explore key questions like:

  • What makes a device a medical device—what types of studies require a device determination?
  • What are the differences between non-significant risk (NSR) and significant risk (SR) device studies—and who determines the status of a device as used in a clinical trial?
  • How can researchers plan ahead—what information is essential for IRB review of device research?

Learning Objectives:

  • Identify which regulations apply to studies of medical and non-medical devices.
  • Describe the differences between NSR and SR device studies.
  • Explain how to navigate the submission process for IRB review of device protocols.

Presented By

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Robert Romanchuk

BSHS, CIP, CCRC, CRCP

IRB Chairperson
Advarra

Kindra Cooper.png

Kindra Cooper

JD, MPA, MA (Bioethics)

IRB Chairperson
Advarra

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Who should watch?

This content applies to IRBs members, investigators, sponsor representatives, research site representatives, research coordinators, research compliance professionals, and other research professionals involved in planning or conducting device research or research utilizing devices

CE Credits

Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.

This session meets the Certified IRB Professional (CIP) recertification guidelines for a maximum of 1 credit.

Provider approved by the California Board of Registered Nursing, Provider Number 17600, 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: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour

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