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Introduction

This introductory course describes the role and responsibilities of CRAs and their job function through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations pertinent to clinical monitoring. The content for this course focuses on drugs and biologics development.

Key Topics
• Good Clinical Practices (GCP)
• Regulatory requirements for clinical research
• Clinical research methodology and its role in drug development
• CRA's role in clinical research
• Monitoring clinical trials to ensure valid and useful study data
• Investigator selection and evaluation
• FDA audits
• Basic HIPPA requirements
• Basic protocol development.

Useful links

Venue

Four Points by Sheraton Washington DC Downtown

Four Points by Sheraton Washington DC Downtown, 1201 K Street NW, Washington, 20005, United Kingdom

Useful links

Organised by

Drug Information Association

Contact information

Mr Marketing Manager
800 Enterprise Road,, Suite 200, Washington, 20005, United States of America
+1.215.442.6100
Contact us by email

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