This 3 day, interactive Good Clinical Practice (GCP) training course is designed to provide CRAs, Research Coordinators, Investigators, IRB and Clinical Research staff with a thorough knowledge and understanding of Good Clinical Practices (GCP) for medical device (IDE/SR) clinical research conducted under the US FDA Code of Federal Regulations (CFR), associated guidances and guidelines, ISO 14155 Medical Device Clinical Investigations and EU Medical Device Directives and Amendments. Through lectures, activities, exercises, case study review and multi-media tools, attendees practice applying the regulations/FDA Guidance Documents in situations that they will encounter 'on the job'.

*Note: This course does not address 510 (k) device regulations*

Faculty:
Liz Wool, RN, BSN, CCRA, CMT
President
Association of Clinical Research Professionals (ACRP)
Northern California Chapter
President and CEO, QD-Quality and Training Solutions, Inc.™

Duration: 24 hours

Course Objectives

• Define medical devices and classifications of devices
• Explain the historical background of clinical research and GCP.
• Examine ethics and conflict of interest in clinical research.
• Identify the regulations, standards and requirements for GCP.
• Understand and apply the sponsor/investigator obligations for the conduct of clinical research in medical devices.
• Compare the US FDA regulations, to ISO 14155 and EU Medical Device Directives and Amendments.
• Describe Good Documentation Practices

Course Outline

Day 1

• Introduction
• Overview of Good Clinical Practice
• Good Clinical Practice: Historical Overview
• Definition and Classification of Medical Devices
• Significant Risk vs. Non-significant Risk Device
• Ethics and Conflict of Interest in Clinical Research
• Financial Disclosure Requirements: Clinical Investigators (21 CFR Part 54) FDA Guidance Document: Financial Disclosure by Clinical Investigators
• HIPAA and HIPAA Authorizations

Day 2

• Human Subject Protection - Informed Consent: Procedure, Process, and Documentation
• Institutional Review Boards/Independent Ethics Committees
• Sponsor and Investigator Responsibilities
• Review of FDA Guidance Documents for these topics
• Group Activities: Review of FDA 483s and Warning Letters/Case Studies for these topics

Day 3

• Adverse Events: Definition, identification, documentation, reporting and follow-up
  • 21 CFR 812 Investigational Device Exemptions
  • ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects
  • EU Clinical Trial Directive: Medical Devices
• Product Quality Complaints Overview: Identification and reporting requirements
• Good Documentation Practices
• Electronic Records and Electronic Signatures (21 CFR Part 11)
• FDA Guidance Document: Computerized systems in clinical research: investigator, sponsor responsibilities
• Wrap-Up

Registration

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