Course Summary

The sponsor of a clinical trial takes responsibility for its initiation, management, and/or financing. A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a contract research organisation, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. Duties and functions discussed in this short course include trial design, selection of investigators, QA and QC, data handling and record keeping, finance and compensation, regulatory submissions, management of investigational product(s), safety reporting, monitoring, audit, dealing with noncompliance, and clinical trial reports. ICH guideline E6 (revision 2) encourages sponsors to adopt a risk-based approach to managing the quality of trials. We discuss this approach in general, and aspects such as risk-based monitoring in particular.

Who will benefit from this module?

This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.

Learning Objectives

• Summarise the main responsibilities of a clinical trial sponsor
• Outline a risk-based approach to managing trial quality
• Describe data-handling and record-keeping functions
• Outline the basis of agreements with investigators
• Describe the management of investigational products
• Specify requirements for safety and ADR reporting
• Specify the purpose and outline the scope of trial monitoring
• Identify responsibilities for audit and dealing with noncompliance

Module Outline

Key topics covered in this module include:

• Risk-based quality management
• Trial management
• Data handaling and record keeping
• Investigator selection
• Regulatory submissions and confirmation of IRB/IEC
• Management of invetigational product(s)
• Safety and ADR reporting
• Monitoring
• Audit
• Noncompliance and premature termination and suspension of a trial
• Clinical trial reports

Assessment - Multiple-choice assessment.