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Course Details

Course Title

Sponsor Responsibilities for Clinical Trials
Course Format

One day classroom course with a mix of presentations and workshop sessions
Learning Objectives

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 is it for?

The course is aimed at those assuming sponsor responsibility for clinical trials and is particularly useful for those who contract out the bulk of the operational aspects of the trial, or non-commercial organisations new to the role of sponsor.
Course Content

Introduction to the clinical trial process

  • Clinical Trial Lifecycle
  • Key roles and responsibilities

ICH GCP Chapter 5

  • Definition of a sponsor
  • Sponsor responsibilities
  • Roles and delegation

EU Legislation

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

Contracts

  • Managing subcontractors
  • Key contents for contracts
  • Managing investigational sites
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