This course is designed to provide a brief overview of clinical research, terminology, and acronyms followed by a comprehensive review of FDA GCP and ICH GCP (E6). It also reviews the fundamental elements involved in coordinating a clinical trial from the investigator’s perspective. It includes practical tips and suggestions that can be applied to promote a GCP and HIPAA compliant clinical trial, including preventative measures and problem solving techniques of some of the most common GCP non-compliance issues. MRM provides each participant with a credit card size CD-ROM Regulatory Reference and access to source document templates and check lists.

• Discuss the drug/biologic development process.
• Define GCP and identify its application in clinical research.
• List the key components of a clinical trial.
• Determine the GCP requirements for the informed consent, adverse and serious adverse events, source documentation and study drug accountability.

Day 1

I. Overview of Clinical Research

• Phases of Research
• Terminology
• Roles and Responsibilities of the Clinical Research Team

II. FDA GCP & ICH GCP-The Investigator's Perspective

Day 2

III. Clinical Trial Fundamentals

• FDA Form 1572 and Protocol/Protocol Amendments and Investigator Brochure
• Investigational Medicinal Product Storage, Documentation, and Problem Solving
• Consenting Subjects
• Source Documentation Strategies
• Case Report Form and Data Clarification Records
• HIPAA compliant Subject Recruitment and Retention
• Interactions with the Monitor
• Budget Issues and tracking payments
• SAEs and Non-SAEs Recognizing and Reporting

Clinical research professionals with limited experience or experienced CRCs interested in obtaining a greater understanding of the GCP and HIPAA requirements, or anyone interested in the field of clinical research.

Seminar Dates	Seminar Location	Seminar Time	Seminar Fees
August 13-14, 2009	Coral Springs, FL	9 AM - 4 PM	$995.00 (15% discount for 3 or more)
October 15-16, 2009	Coral Springs, FL	9 AM - 4 PM	$995.00 (15% discount for 3 or more)
December 10-11, 2009	Coral Springs, FL	9 AM - 4 PM	$995.00 (15% discount for 3 or more)
Register by Phone: 877-633-3322 OR Print Application (pdf) and Fax To: 954-346-2791		Accommodations Coral Springs: Coral Springs Marriott Ask About Student Discount (Availability limited)

Florida State Provider #NCE3423, Provider approved by the California Board of Registered Nursing, Provider #CEP 13617 for 11 contact hours. Credits can be applied to ACRP 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.