History, Terms, Definitions and Regulatory Requirements

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:

This course will explore core concepts of FDA regulations including: study risk categorization and device classifications, IDE application process for industry and investigated-initialed trials, requirements and responsibilities in IDE trials, trial types for commercialization, guidance in consulting FDA, and coordination on multi-site IDEs.

Topics:

1. Clarifying between Drugs vs. Devices in clinical trials
2. Device Classifications
   • Class I
   • Class II
   • Class III
3. Study Classifications
   • Studies subject to IDE regulations
     • Significant Risk
       • Full requirements
   • Non-significant Risk (NSR)
     • Abbreviated requirements
     • IRB determination
   • Studies exempt from IDE regulations
4. IDE exempt devices
   • Studies of devices or substantial equivalent if used according with labeling
   • Most in vitro diagnostic devices
   • Previously cleared devices testing:
     • Consumer preference
     • Certain device modifications
     • Comparison testing
   • Basic physiology / research studies
5. NSR Study Examples
6. Significant risk device IDE requirements
   • Who decides significant risk determination?
7. Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studieshttps://www.fda.gov/media/75459/download
8. Office of Device Evaluation
9. Combination Devices
   • Primary Mode of Action
     • FDA Center for Devices and Radiological Health (CDRH)
     • FDA Center for Drug Evaluation and Research (CDER)
10. Stages of Trials for Commercialization and Comparison
    • Early feasibility trials
    • Feasibility trials
    • Pivotal trials
11. Early feasibility trials:
    • Requirements
    • Timelines
12. IDE submission requirements
    • Device information
    • Report of prior investigations
    • Risk analysis
    • Clinical protocol
    • Manufacturing information
    • Labeling
    • Additional requirements
13. Investigator’s reporting requirements
14. Sponsor’s reporting requirements
15. Governing regulations: drugs vs. devices
    • Drugs
      • 21 CFR Part 211: Current Good Manufacturing Practices
      • 21 CFR Part 312: Investigational New Drug Application
    • Devices
      • 21 CFR Part 820: Quality Systems Regulations
      • 21 CFR Part 812: Investigational Device Exemption
16. Complexity in device protocols
17. Typical features of device trials
18. Advice for clinical research associates/coordinators
19. Adverse event reporting differences
20. Problems in early device trials

Speaker:

Frances Richmond, PhD is a Professor in the Department of Regulatory and Quality Sciences and the Director of the D.K. Kim International Center for Regulatory Science in the School of Pharmacy. She comes to USC from Queen’s University, where she was Professor and Director of the Medical Research Council in Sensory-Motor Neuroscience. Dr. Richmond’s research interests have included both basic and applied studies of movement systems. She is conducting animal and clinical trials of implantable devices and consults on regulatory aspects of medical product development. She is currently directing Program of Certificate, Master’s and Doctorate programs in Regulatory Science at the University of Southern California. Her current interests are focused on the regulatory and clinical management of new product development in biomedical areas.   fjr@usc.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 2.0 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 first 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