Topic

Speaker **

 Session I: Patient’s Rights / Investigator Ethics

Why is Investigator Training Important?  Investigator Ethics

Michael J. Koren, MD, FACC

Protecting Patients’ Rights / Informed Consent Issues

Michael McIvor, MD

The Role of the Institutional Review Board

John M. Isidor, JD

HIPAA and Legal Considerations in Clinical Research 

John M. Isidor, MD

Case Studies: Ethical Issues in Clinical Research

Susan N. Greco, MD, MPH
Michael McIvor, MD
John M. Isidor, JD

Session II: Understanding Clinical Trial Operations

Clinical Trial Participation / Outreach Methods

James Powell, MD

Managing and Reporting Adverse Events and Lab Abnormalities

Susan N. Greco, MD, MPH

Source Documents and Data Organization

Susan N. Greco, MD, MPH

Non-traditional Trials: Devices, Gene Therapy and Imaging Research

Michael McIvor, MD

Case Studies: Patient Management Issues in Clinical Trials

Susan N. Greco, MD, MPH
James Powell, MD
John M. Isidor, JD

Session III: Managing a Research Practice

How to Start & Manage a Successful Clinical Research Practice

Michael McIvor, MD

Financial and Practical Consideration in Clinical Trial Success

Michael J. Koren, MD, FACC

Case Studies: Managing a Research Practice

Michael J. Koren, MD, FACC
Michael McIvor, MD