Introduction to Clinical Trials Monitoring

• Importance of Research & Development, Discovery, Design Prototype in pre-Healthcare Authority Studies
• Role of the Clinical Research Team
• Historical Perspectives for Clinical Research Monitoring and Official Documents
• Role and Functions of Monitors
• Role of Sponsor, Institutional Review Committees, Investigators, and Study Subjects

Navigating the Regulatory Framework 

• Definitions of Regulatory Terms
• Managing the Revisions to the Medical Device Directive
• Assuring a Successful Transition from the Old to New Directive
• Clinical Trials Regulation and Guidelines
• Development of Clinical Research Plan, Clinical Utility, Statistical and Clinical Endpoints

Marketing and Strategic Management for Medical Devices 

• Device Classification
• Applications for Medical Devices
• Science-Based Product Life Cycle
• Quality System Requirements / Design Control Plans
• Good Clinical Practice and Management of the Clinical Study Design
• Regulatory Differences/Nuances Between Major Global Areas: U.S., EU, Japan, Latin America
• Organizing and Managing the Clinical Trial

Good Science as it Relates to Clinical Studies  

• Definition of Good Science
• Development of Scientific Methods
• Concepts of Quality Data and Integrity
• Role of the Principal Investigator and the Laboratory in Clinical Trials
• Role of Institutional Review Boards (IRBs), Principal Investigator, and Clinical Sites 
• Principle Applications of Clinical Research Combined with Health Care Delivery System

DAY TWO

Importance of Informed Consent

• Research Practice, Ethical Principles, and Study
• Informed Consent, Oral or Written
• Waiver / Liability
• Investigational Device Use
• Health Insurance Portability and Accountability Act (HIPPA) for Privacy and Security Compliance

Patient Information and Studies   

• Recommendations for Information Sheets
• Protection of Human Subjects
• Principles and Guidelines for Clinical Studies involving Human Subjects

Applications for Informed Consent

• Assessment and Monitoring of Benefits vs. Risks
  Institutional Review Committees Membership and Operations
• Assuring Compliance and Monitoring Visits, Records, Reports and Use of Source Documents

Monitoring Safety and Adverse Events Requirements

• Monitoring of Data Integrity
• Monitoring Documents
• Good Document Practices

Good Clinical Practice - International Conference on Harmonization Published Guidelines (ICH-GCPs)

• Committee Membership and Responsibilities
• Composition, Functions, Operations, Procedures, and Records
• Approval and Disapproval
• Documentation on Device History Files and Master Records
• Risk Management and Role of Clinical Safety in Product Life Cycle
• Post-Marketing Studies / Bioresearch Monitoring
• Device Examples and Case Studies

Sponsor Documentation

• Pre-study Documentation
• Clinical Research and Investigator Documentation
• Sponsor Study File
• Management of New Product Development, Evaluation Phases, and Final Approval

Staying “Leading-Edge in Good Monitoring Practices”

• Sources of Information
• Advantages of Surveillance on Regulatory Changes, Information Technology and New Tools
• Time Management – Surveillance Options and Efficiency Gains Concepts

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