Good Clinical Practice (GCP) for Medical Devices
Agenda: Day One
I. Overview of Medical Device Regulation
- Outline FDA organizational structure and roles of offices within the Center for Devices & Radiological Health (CDRH)
- Identify FDA laws, regulations and guidelines governing device regulation
- Define and describe the three medical device classification categories and distinguish between Significant Risk (SR) and Non-significant Risk (NSR) devices/studies
- Clarify clinical trial regulatory requirements and processes
- Illustrate pre-market pathways
- Define key terms and acronyms
Exercise: Determine Participants' Level of Experience and Course Goals
II. Interpret FDA/ICH GCP Regulations and Guidance
- Identify regulations and guidance governing good clinical practice
- Elucidate key differences between medical device and pharmaceutical requirements
- Apply relevant ICH GCP guideline elements to medical device studies
- Determine good clinical practice resources
III. Clarify Roles and Responsibilities of Key Personnel Involved in Clinical Trials
- Identify the roles of the sponsor, monitor and clinical investigator
- Determine the role of the Institutional Review Board (IRB)
- Review criteria for making SR and NSR determinations
- Discuss tools for preparing an investigational device exemption (IDE) application
Exercise: Create an IRB Assessment Plan for Clinical Site Qualification
IV. Protect Human Subjects Enrolled in Medical Device Clinical Trials
- Determine the requirements for informed consent
- Identify exceptions to informed consent requirements
- Write appropriate informed consent documentation
- Elucidate applicable Privacy Rule (HIPAA) requirements
Exercise: Critique an Informed Consent Document for Regulatory Compliance
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.