PROGRAM OUTLINE

Good Clinical Practice

Duration: 2 days

Audience :

• Medical department personnel in pharma industry
• Clinical trial management personnel
• Biometrics related personnel
• Ethics committee members
• Investigators and research personnel

Content

• Drug development process
• Introduction to GCP
• Regulatory requirements
• Independent Ethics Committee (IEC)
• Investigator
• Sponsor's Responsibilities
• Monitor's Responsibilities
• The Investigational product
• Safety & Adverse Event Reporting
• Clinical Trial Protocol and Amendments
• Investigator’s brochure
• Essential Document

On successful completion of the course, the participant will be able to:

• Demonstrate an understanding of the importance of the interwoven laws, frameworks and guidelines which govern the set up and conduct of clinical research
• Demonstrate an understanding of the roles and responsibilities of different individuals and organisations in clinical research
• Identify a range of essential documents and the purpose of maintaining a trial master file
• Understand the process of receiving informed consent and the roles and responsibilities of those involved in this process
• Demonstrate the ability to correctly and accurately complete case report forms and other relevant documentation and understand the process for data query resolution
• Demonstrate an awareness of the correct reporting requirements that ensure patient safety