IRB Reviews on Medical Device Trials

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

Sound ethical practices must be applied in clinical trials using human subjects for medical device development. The 2^nd course in a 7-part series, medical device review will be discussed from the perspective of the Institutional Review Board (IRB).  Topics explored include FDA regulations and guidance for Significant Risk (SR) and Non-Significant Risk devices (NSR), Humanitarian Use Device (HUD), Emergency Use, custom device, exempt review, and local IRB application processes. 

Topics:

1. FDA classifications of medical devices
   • Class I, II, and III devices
   • Examples
2. Premarket Notification (510k)
3. Premarket Approval (PMA)
4. Humanitarian Use Device (HUD) and Humanitarian Exemption (HDE)
   • Definition
   • Submission requirements
5. 21 CFR Part 812: Investigational device exemptions
   • Significant Risk Devices
   • Non-Significant Risk Devices (NSR)
6. Institutional Review Board (IRB) responsibilities for NSR device studies
7. Exempt review studies
8. IRB review responsibilities
9. FAQ on devices
10. Emergency Use/Expanded Access
11. Compassionate Use
12. Custom device
13. Local device electronic submission example

Speaker:

Kristin J. Craun, MPH, CIP, is the Director of the IRB at the University of California Los Angeles. She received her B.A. from Boston University and her MPH from the University of California Los Angeles. Kristin is completing her Doctorate in Higher Education Leadership at the University of Southern California. Kristin is an AAHRPP council member and site reviewer. She is a faculty member of Public Responsibility in Medicine and Research (PRIM&R) and the Association for Accreditation of Human Research Protection Programs (AAHRPP). She was also the recipient of the 2016 Distinguished Site Visitor Award for AAHRPP.   kristin.craun@research.ucla.edu

Learner Level: Beginner

Audience:

This symposium is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience.  Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.  Attendees to this CNE activity will be awarded 0.75 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the second course in a seven session program. To complete the entire program and earn badge Click Here.

Learner Disclosures:

Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.

Awarding Contact Hours: To obtain contact hours participants must:

·       Review the entire activity

·       Pass the quiz

·       Complete the evaluation at the end

 Certificates will be distributed at the end of the evaluation.

Enduring Materials Dates:

·       Start Date: 4/22/2024

·       Expiration Date: 4/22/2027