The clinical trial sponsor carries ultimate responsibility for a clinical trial. This training explains why this is so important and where the specific responsibilities come from. We also look at how these responsibilities can be met and also how you can demonstrate compliance and oversight in the event of an inspection.
We can also cover responsibilities when contracting out work to a vendor: how to select and manage vendors and how to demonstrate oversight of contracted tasks, duties and functions
By the end of this course participants will be able to:
- Describe the main milestones of the clinical trial process
- Outline the responsibilities of the clinical trial sponsor
- Identify the key aspects to consider when delegating to vendors and investigational sites
Who it is suitable for:
The course is aimed at those assuming sponsor responsibility for clinical trials and can be tailored for those who contract out the bulk of the operational aspects of the trial, or non-commercial organisations new to the role of sponsor.
Introduction to the clinical trial process
Clinical Trial Lifecycle
Key roles and responsibilities
ICH GCP Chapter 5
Definition of a sponsor
- Quality Management
- Study design
- Risk Assessment and mitigation plans
- Site management
- Site Selection
- On-site and centralized monitoring
- Site closeout
- Supply and handling of IMP
- Safety reporting
- Data Integrity
- Final Study Report and other reports required
Roles and delegation
Sponsor responsibilities under EU legislation
Local legislation where applicable
Key contents for contracts
Issue Escalation and Quality Management
Please contact me for more information and to organise your course.
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