Course Description

FDA inspections in today’s regulatory climate go beyond checking for a signed consent form and source data verification of the case report form. Today, inspections focus on how the cycle of quality is implemented for all aspects of the sponsor’s investigational plan. This includes Clinical Investigator supervision of the protocol’s execution in alignment with state statute/regulatory requirements. When there is an error/deficiency identified during the trial execution — what is done to address and correct this finding? And, if the same problem occurred again in the clinical trial do you know how to respond? In this web seminar, these questions will be further examined and examples will be reviewed on how sites implement ‘quality practices’ for trial execution that includes the health care standards/statutes for the site location.

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Learning Objectives

• Understand that clinical trial execution requirements in 2016 is more than being compliant — it is about the prospective cycle of quality
• Distinguish attributes of patient care/health care standards/clinical care and scope of practice that apply to the execution of clinical trials
• Translate regulatory agency expectations regarding Clinical Investigator supervision, oversight and control of the clinical investigation

Who Should Attend

• Principal Investigators
• Clinical Research Coordinators
• Directors: Clinical Trial Unit and Clinical Trial Offices
• Office of Research Compliance and Risk Management Personnel
• Managers/Directors: Clinical Operations
• Study Managers and Monitors/Clinical Research Associates (Centralized, On-site)
• Quality Assurance Professionals

Instructor

The course will be led by one of the following instructors:

Liz Wool, R.N., B.S.N., C.C.R.A., CID, CMT

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.