Fundamentals of Clinical Research Monitoring Blended Learning Course

Venue: Loews Philadelphia Hotel

Location: Philadelphia,, Pennsylvania, United States

Event Date/Time: Nov 07, 2011 End Date/Time: Nov 08, 2011
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This blended learning offering provides a two-part webinar series focusing on the fundamental concepts of clinical research monitoring and GCPs followed by a live two day course of interactive lectures and hands-on workshop training methods that will provide you with the tools to effectively monitor clinical studies.

What You Will Learn

• Good Clinical Practices (GCP)

• Regulatory requirements for clinical research

• The role of the IRB and IRB interactions

• The importance of the Informed Consent Document and tips for improving readability

• Clinical research methodology and its role in drug development

• CRA’s role in clinical research

• How to identify and handle adverse events at the site

• Monitoring clinical trials to ensure valid and useful study data

• Practical tips for successful monitoring

• Investigator selection and evaluation

• FDA audits

• Basic HIPAA requirements

• How to fix common problems found during monitoring visits

• Basic protocol development

Learning Objectives:

At the conclusion of this course, participants should be able to:

• Describe the basic clinical research elements in drug development

• Recognize the basic elements of clinical trial methodology in the conduct of clinical studies

• Identify roles and responsibilities, and regulatory requirements pertinent to clinical research associates

• Apply "hands-on" clinical trial monitoring experience to the conduct of clinical studies

• Discuss the importance of selecting qualified clinical investigators and its impact on the clinical trial process

• Recognize the requirements for safety surveillance

• Apply the principles of auditing in clinical investigations

• Recognize the elements of protocol development

Target Audience:

• Clinical research associates and clinical study monitors with less than two years of experience

• Clinical development personnel wishing to learn more about the role and process of monitoring studies

• Administrative support personnel

• Project Managers

• Data entry personnel

• Emerging Clinical Research Professionals

• Regulatory Affairs professionals

• Statisticians

• Safety Surveillance professionals

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