Workshops are NOT included with Full Conference registration and require a separate fee.

This pre-conference workshop is aligned with the ICH E6 Good Clinical Practice Guidelines and the ACRP Core Competency Guidelines to help build a solid foundation of knowledge for all clinical research professionals. The workshop will be broken up into two parts with all attendees together for the first half of the day to learn the general information and then breaking up into Clinical Research Site Team Members and Sponsor/CRO Team Members to emphasize on the responsibilities pertaining to their tasks and opportunity for a few exercises.

Objectives:

1. Recognize the key guidelines utilized in the clinical research industry.

2. Describe the Informed Consent Process and the key elements of Informed Consent.

3. Outline the Safety Reporting process.

4. List the responsibilities of the key stakeholders in the clinical research industry. (Sponsor, CRO, Principal Investigator, IRB, etc.)

CEU: 8.00 ACRP

Trainers:

• John Rowell, Jr., MSN, CEO, Bio Research Consulting

• Mary Lord, RN, MS, CCRA, CRA Manager, Site Management and Monitoring, Merck

• Brian Hollis, MD, Research Investigator, Quality Clinical Research

• Laura Herrera, DNP, APRN, FNP-C, CPI, Sub-Investigator, Western Sky Medical Research

• Cassandra Reynolds, Clinical Trials Manager, Cardiovascular Medicine, Vanderbilt University Medical Center

Please choose W24-01: Clinical Research 101: Setting the Foundation for Success to register for this event. Lunch will be provided for full-day workshop registrants.

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