The GCPs of Essential Documents December 2012

Dec 12, 2012


	Order the DVD of this seminar Single Copy - $695.00Site License - $1,695.00

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 ICH GCP E6 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.

VideoPreview

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

Nikki Christison, B.S.

Click here for complete trainer biographies

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.

On-Demand GCP Refresher Training

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.

Barnett "Hands-On" Workshops are designed to provide intensive, hands-on training in a highly targeted clinical research topic area in a very interactive and engaging learning environment. To view more details and available courses, click here.

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