This seminar was designed for those who desire an overview of the device approval process, the regulations that govern IDE studies, the CRA's role in monitoring, and the FDA's role in auditing. It includes a review and discussion on recent monitoring and research site warning letters. It consists of a comprehensive review of the GCP obligations of the sponsor and the investigator, the FDA Guidance: Investigator Supervisory Role, the regulations that protect the rights and safety of human subjects. A glance at the similarities and differences between the FDA regulations and the ICH GCP (E6) guideline, and a review of some key safety definitions from ISO 14155-1:2003. It also reviews the key documents and elements of the clinical investigation at the site level, including the Investigator Study File and the Sponsor's Trial Master file, as well as all the report requirements and the reporting timeframes. Informed Consent and AE Exercises are performed to enhance learning. MRM provides each participant with a CD-ROM Regulatory Reference.

• List the sponsor's, investigator's and IRB's responsibilities in medical device studies.
• Discuss the monitoring activities performed for an investigational device study.
• Identify adverse device effects and their reporting requirements.
• Discuss the differences between the IDE Application versus the 510K and the PMA.
• Recognize the purpose of the FDA BIMO Inspection program.

Day 1

I. Overview of the Medical Device Approval Process

• History/Legislation
• Device Classification (Class 1,2, and 3)
• IDE Submission
• Overview of the Marketing Clearance, including De Novo
• 510 k (Traditional, Special, Abbreviated, de novo)
• PMA, HDE and PDP

II. FDA GCP and ICH GCP

• FDA GCP: Sponsor and Investigator Obligations 21 CFR 812
• FDA Guidance: Investigator Supervisory Role, October 2009
• Overview of ICH GCP (E6) Section 5: Sponsor
• FDA GCP: Investigator Obligations 21 CFR 812
• Overview of ICH GCP (E6) Section 4: Investigator
• Financial Disclosure by Clinical Investigators (21 CFR 54)

Day 2

III. Key Clinical Trial Elements

• Investigator Agreement
• Regulatory Documents: Investigator File versus the Sponsor's Trial Master File
• Clinical Investigational Plan Content
• Study Device Accountability
• Adverse Event definitions (ICH GCP E2A, and ISO 14155-1:2003)
• Adverse Device Effects
• Serious Adverse Device Effects
• Serious Adverse Events
• Unanticipated Adverse Device Effects
• AE Drill Exercise

IV. Protection of Human Subjects

• IRB Role and Responsibility
• Informed Consent Requirements, the use of Exceptions, and Documentation
• ICH GCP (E6) Consent Similarities and Differences
• HIPAA: Research Authorization Requirements
• Informed Consent Compliance Exercise

V. Monitor Role and Responsibilities

• Monitoring Visit Types & strategies for Effective Visits
• Monitoring Responsibilities and Techniques
• MRM Step Monitoring Method, the 8 R’s to Consent GCP Compliance Verification, the 5 R’s to HIPAA Compliance Verification
• Monitoring Plan Content and Documentation

VI. FDA's Bioresearch Monitoring Program (BIMO)

• BIMO Program Objective and Function
• What Happens During an Audit?
• Typical FDA Audit Findings and their Classification
• What is Fraud and Misconduct?

CRA's and other Device Industry professionals who want to gain knowledge about the device approval process, GCP governing IDE studies, and the monitoring role.

Seminar Dates	Seminar Location	Seminar Time	Seminar Fees
Register by Phone: 877-633-3322 OR Print Application (pdf) and Fax To: 954-346-2791		Accommodations Ask About Student Discount (Availability limited)

Florida State Provider #50-11408, Provider approved by the California Board of Registered Nursing, Provider #CEP 13617 for 11 contact hours. Credits can be applied to ACRP and SoCRA certification.

Cancellations by registrants must be provided in writing prior to the start date of the seminar, such registrants shall receive a credit voucher toward a future MRM seminar. Companies may substitute someone registered with another participant at any time. MRM reserves the right to cancel a seminar due to poor enrollment or acts of nature and shall not be responsible for any airfare, hotel, or other costs. MRM shall offer a credit voucher to a future seminar or a complete refund for MRM Seminar cancellations. Seminar topics and speakers may be subject to change without any prior notice.