Fairplay Consultants, Inc. - FCI Clinical Trial Research Professional Self-Study Course

FCI Clinical Trial Research Professional Self-Study Course

Description:

This is a six-week self-study course divided into two modules comprised of information related to the fundamentals of clinical trial research created especially designed for the transitioning employee and entry-level professional.

Course Level:

Beginner

Overview:

This is a six-week self-study course divided into two modules comprised of information related to the fundamentals of clinical trial research created for and especially designed to assist the new and transitioning entry-level clinical trial professional. This course can also serve as a comprehensive review of the basics in Good Clinical Practice (GCPs) for clinical trial professionals including Clinical Research Associates (CRA), Investigators (PI/Sub-PI), Clinical Research Coordinators (CRC), Institutional Review Board Members (IRBs), and other clinical research team members.

New and experienced clinical trial industry professionals will benefit from this intensive self-study program designed to introduce the clinical research professional to the world of pharmaceutical drug research and development (R&D), good clinical practices (GCPs), the FDA regulatory agencies, and the International Conference on Harminozation (ICH).

Who Should Attend:

Seasoned professionals can use this self-study course to prepare for the ACRP and SoCRA certification examinations, in that, the course materials present many current predicate rules, guidelines, and regulations which comprise Good Clinical Practices (GCPs). This course will ensure an understanding of the clinical trial process and nuances of drug development with special attention devoted to human safety protection ethical considerations. The participant will begin to develop skills and knowledge to effectively adapt to their "on-the-job" performance during clinical trial conduct. Each participant will earn a "Certificate of Participation" for successful completion of Module Entry Level (two-week introductory course) and Module Senior Level (4-week comprehensive "Foundations" course). Lead Trainer: Carolyn E. Rugloski, MS.

Objectives:

Understand the responsibilities, regulations, and guidelines associated with the ethical conduct of clinical trials.

Agenda:

Self-Study

Please note:

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

For further training in this subject area, please consider:

Human Research Protection Workshop

Notes:

2 modules, Module Entry Level is required prior to taking the Module Senior Level.