PharmaSchool: Sponsor Responsibilities for Clinical Trials

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: GGL011

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Duration: 1 day

Description:

This course provides a working knowledge of the key responsibilities of Sponsors of clinical trials

Who it is suitable 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.

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
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

Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
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