International Psoriasis Council

Chapters

Opening
Introduction
Chapter 1
The Evolution of the Clinical Trials Process - A Brief History Lesson
Chapter 2
It Takes a Village to Conduct a Clinical Trial
Chapter 3
Not All Clinical Trials are Created Equal - Understanding the Different Phases
Chapter 4
There's No Going Outside the Lines - Ethical Considerations in the Conduct of Clinical Trials
Chapter 5
What You Need to Know to Live in Harmony with Your Institutional Review Board and Research Ethics Committee
Chapter 6
Be Informed About Informed Consent
Chapter 7
Practical Advice for Following Good Clinical Practice
Chapter 8
Living in a Material World - What is Needed to Run a Successful Clinical Trial
Chapter 9
Clinical Trial Coordinators - A Vital Sign of a Good Clinical Trial
Chapter 10
The Subject of Recruitment and Retention
Chapter 11
The Investigational Compound - Like Handling Kryptonite
Chapter 12
Budgets and Contracts - Show Me the Money
Chapter 13
Everything You Write Can Be Used Against You in a Court of Law - Understanding Proper Documentation
Chapter 14
Audits/Inspections - Be Prepared for Anything
Chapter 15
Conducting Clinical Trials Without Ending Up on Trial

Opening

What You Need to Know to Conduct a Clinical Trial and How to Avoid Common Pitfalls

Program Overview

The International Psoriasis Council (IPC) identified a need for educating clinicians interested in clinical research, as well as nurses and administrators, on the various aspects of conducting clinical trials, hopefully, to increase the number of clinical researchers. This initiative, consisting of 15 original chapters, is derived from a clinical conference sponsored by IPC to discuss important elements of conducting clinical research in both private practice and academic settings. It is designed to help the reader gain insight into aspects of conducting good clinical research, identifying common pitfalls, and providing practical and technical details of the clinical research process. This is a resource for those interested in becoming involved in their first clinical trial or those who are already involved and looking for greater participation.

Program Chairpersons

Craig Leonardi, M.D., Central Dermatology, St. Louis University Medical School, St. Louis, MO

Kim Papp, M.D., Ph.D., Probity Medical Research, University of Western Ontario, Waterloo, Ontario

Audience

This activity has been designed to meet the educational needs of physicians and other healthcare providers who are interested in participating in clinical trial research.

Release date: June 1, 2009

Expiration date: May 31, 2011

Estimated time to complete activity: 7.5 hours (total time for all 15 chapters)

Requirements: This activity requires one of the following browsers: Firefox, Safari, or Internet Explorer 6+. Certain educational activities may require additional software to view multimedia, presentation or printable versions of their content. These activities will be marked as such and will provide links to the required software.

For more information, please contact the Postgraduate Institute of Medicine at www.pimed.com

Jointly sponsored by the Postgraduate Institute for Medicine, BioCentric, Inc., and the International Psoriasis Council