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Clinical trial sponsor’s ICH E6(R3) GCP responsibilities
Course Summary
The sponsor takes responsibility for the trial’s initiation, management, and the organisation of financing. The responsibility of the sponsor entails the implementation of risk-proportionate approaches to ensure the protection of trial participants and the reliability of trial results throughout the clinical trial life cycle. Added in the third revision of ICH GCP are expectations of the sponsor’s resources, qualifications and training of personnel, agreements (including with service providers), and oversight of trials. In this course, we set out the sponsor’s responsibilities in detail.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Outline GCP expectations for the preparation and design of a clinical trial
• Summarise the sponsor’s responsibilities for trial oversight
• Describe the sponsor’s responsibilities for quality management, including risk management,
quality assurance and quality control
• Outline measures to deal with noncompliance
• Specify the sponsor’s responsibilities for safety assessment and reporting
• Specify the sponsor’s responsibilities for the quality and supply of the investigational product(s)
• Outline GCP expectations of the sponsor regarding data and records
• Describe GCP expectations of the sponsor’s use of computerised systems
• Describe the sponsor’s responsibilities for statistical programming and data analysis
• Identify reports required of the sponsor
Who will benefit from this course
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.
Module Outline
Roles
Research, Regulatory, Compliance
CPD Points
No
Region
Level
Foundation
Course Study Time
Approx 50 minutes
USA, Europe, Other