Course Description

Understanding the big picture of how essential study documents impact the approval and ethics of a clinical research trial often gets overlooked in the rush of document collection and requests. The foundation of this web seminar is the site study file, what the documents are, and why they are important as related to the ICH GCP E6 Guideline Essential Documents and 21 CFR 50, 54, 56 and 312. This web seminar will also provide a reference point for why the paperwork is so critical within the process of a study.

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Learning Objectives

• Describe the investigational product development process and the role of documentation
• Discuss the roles and responsibilities during the study document handling process
• Review the importance of study files and essential documents handling including review of FDA audit findings

Who Should Attend

• Study Coordinators
• Site Regulatory Managers
• Clinical Research Associates
• Project Assistants
• Regulatory Assistants
• Site Managers

Instructor

Marla Hoelle, B.S.N., R.N., C.C.R.A., ACRP-PM., P.M.P.

Click here for complete trainer biographies

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