Fairplay Consultants, Inc. - Clinical Research 101

Clinical Research 101

Description:

Basics of setting up a clinical trial research site, reading the protocol, delegating duties, conducting research, setting up SOPs, and securing grants and trials.

Overview:

This course is the most basic research course known to be currently available. Participants will be taken from a presumed zero knowledge base to a basic working ability to start working appropriately with clinical trials. Highlights will include an introduction to Good Clinical Practice, the Code of Federal Regulations, and the importance of ethics in research practice. The role of the Clinical Research Coordinator and Clinical Research Associate will be defined; how they differ, how they are similar, as well as how they interact together. The roles played by other members of the research team will be introduced, defined, and discussed -- including the FDA, other regulatory authorities, the sponsor, the CRO, the IRB, and the rest of the Research Alphabet Soup. One textbook and two original course manuals will be used (provided) in this course: The Fairplay Consultants Inc. "Model SOP Manual" and the "Model Investigator Manual." Both of these manuals will be invaluable as office reference books following the course and are not available outside of course participation. We will also refer to the Code of Federal Regulations and the International Conference on Harmonization for Good Clinical Practice. Discussion will be laced with interesting highlights from the history of clinical research, world events precipitating our existing laws and guidelines, and good-natured clinical research humor. Clinical Trial Study Site tools-of- the-trade will be introduced for future study site set-up reference and use.

Who Should Attend:

Anyone who desires a basic introduction to the proper conduct of clinical trial research practice! For example: Principal Investigators Clinical Research Coordinators Clinical Research Associates Clinical Research Nurses Clinical Research Pharmacists Department Administrators interested in an overview of clinical research -- or any other ancillary clinical trial personnel

Objectives:

The participant will:

Demonstrate a basic knowledge of GCPs and study-site tools needed to set-up a study site and conduct clinical research.

Discuss the overview of the clinical development process

Identify ways to secure new clinical trials and grant opportunities

Describe how to effectively and efficiently conduct clinical trials

Explain how to set up and manage a research center

Agenda:

Two textbooks offered as optional purchases for this course are entitled "Lessons from a Horse Named Jim" which includes a CD-Rom on-line review and exam. The second optional textbook is the Centerwatch The Investigator's Guide to Clinical Research. Two original FCI site manuals are provided with course registration and will prove to be invaluable to study site start-up. A Certificate of Participation is provided along with the opportunity to earn continuing education units (CMEs)through the Centerwatch textbook purchase.

As our learning environment is intended to be open and interactive, we invite you to dress comfortably (business casual) but to be prepared for a cool room, if necessary. We hope each participant's learning experience will be a personal one and also invite you to be prepared with questions specific to your situation.

Please note:

If you would like to see this course offered in your area, please contact us for scheduling opportunities and fees.