Sponsor Responsibilities

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.

Example content:

Introduction to the clinical trial process

Clinical Trial Lifecycle
Key roles and responsibilities

ICH GCP Chapter 5

Definition of a sponsor
Sponsor responsibilities

  • Quality Management
  • Study design
  • Risk Assessment and mitigation plans
  • Finance
  • 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

EU Legislation

Sponsor responsibilities under EU legislation
Approvals/licenses required
Local legislation where applicable


Vendor Selection

Managing vendors
Key contents for contracts

Vendor oversight
Issue Escalation and Quality Management

Please contact me for more information and to organise your course.

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